Nitrous oxide: List of nationally authorised medicinal products - … · Medicinal nitrous oxide SIAD Medicinal gas, liquefied CZ/H/0301/001 05/614/08-C SIAD CZECH SPOL.S.R.O. CZ

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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

30 January 2019 EMA/173529/2019 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: nitrous oxide, nitrous oxide / oxygen

Procedure no.: PSUSA/00010572/201806

List of nationally authorised medicinal products EMA/173529/2019 Page 2/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

OXYNOX 135, gaz pour inhalation, en bouteille

not available NL 30160 AIR PRODUCTS S.A.S FR

ANTASOL 135, gaz pour inhalation, en bouteille

not available 562 165-2 SOL FRANCE FR

ANTASOL 135, gaz pour inhalation, en bouteille

not available 396 424-7 SOL FRANCE FR

ANTASOL 135, gaz pour inhalation, en bouteille

not available 396 425-3 SOL FRANCE FR

ANTASOL 135, gaz pour inhalation, en bouteille

not available 563 387-9 SOL FRANCE FR

ANTASOL 135, gaz pour inhalation, en bouteille

not available 564 423-9 SOL FRANCE FR

ANTASOL 135, gaz pour inhalation, en bouteille

not available 564 439-2 SOL FRANCE FR

PROTÓXIDO DE NITRÓGENO MEDICINAL PRAXAIR, gas para inhalación, en botella

not available 67388 PRAXAIR ESPAÑA, S.L. ES

Protoxyde d'azote médicinal Messer Belgium, 100 % v/v , gaz médical liquéfié

not available BE187327 MESSER BELGIUM N.V. BE

List of nationally authorised medicinal products EMA/173529/2019 Page 3/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Protoxyde d'azote médicinal Messer Belgium, 100 % v/v , gaz médical liquéfié

not available BE226091 MESSER BELGIUM N.V. BE

Medicinski didušikov oksid Messer 100 % medicinski plin, utekocinjeni

not available 5363-I-1354/13 MESSER SLOVENIJA D.O.O. SI

Medicinski didušikov oksid Messer 100 % medicinski plin, utekocinjeni

not available 5363-I-1353/13 MESSER SLOVENIJA D.O.O. SI

Medicinski didušikov oksid Messer 100 % medicinski plin, utekocinjeni

not available 5363-I-1352/13 MESSER SLOVENIJA D.O.O. SI

Medicinski didušikov oksid Messer 100 % medicinski plin, utekocinjeni

not available 5363-I-1351/13 MESSER SLOVENIJA D.O.O. SI

Medicinski didušikov oksid Messer 100 % medicinski plin, utekocinjeni

not available 5363-I-1350/13 MESSER SLOVENIJA D.O.O. SI

Medicinski didušikov oksid Messer 100 % medicinski plin, utekocinjeni

not available 5363-I-1349/13 MESSER SLOVENIJA D.O.O. SI

List of nationally authorised medicinal products EMA/173529/2019 Page 4/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Medicinski didušikov oksid Messer 100 % medicinski plin, utekocinjeni

not available 5363-I-1348/13 MESSER SLOVENIJA D.O.O. SI

Medicinski didušikov oksid Messer 100 % medicinski plin, utekocinjeni

not available 5363-I-1347/13 MESSER SLOVENIJA D.O.O. SI

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/02 MESSER HUNGAROGÁZ KFT HU

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/03 MESSER HUNGAROGÁZ KFT HU

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/04 MESSER HUNGAROGÁZ KFT HU

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/05 MESSER HUNGAROGÁZ KFT HU

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/06 MESSER HUNGAROGÁZ KFT HU

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/07 MESSER HUNGAROGÁZ KFT HU

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/08 MESSER HUNGAROGÁZ KFT HU

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/09 MESSER HUNGAROGÁZ KFT HU

List of nationally authorised medicinal products EMA/173529/2019 Page 5/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Dilämmastikoksiid, 100% meditsiiniline gaas, veeldatud

not available 330800 ELME MESSER GAAS EE

DIAZOTO OKSIDAS ELME MESSER GAAS 100 % medicininės dujos, suskystintos

not available LT/1/11/2556/002 UAB ELME MESSER LIT LT

Dušicni oksidul Messer, medicinski plin, ukapljen

not available HR-H-657282253 MESSER CROATIA PLIN D.O.O. HR

Dinitrogén-oxid MESSER cseppfolyósított orvosi gáz

not available OGYI-T-21825/01 MESSER HUNGAROGÁZ KFT HU

PODTLENEK AZOTU, nie mniej niz 98,0% (VN), gaz medyczny skroplony

not available 9388 MESSER POLSKA SP. Z O.O. PL

DIAZOTO OKSIDAS ELME MESSER GAAS 100 % medicininės dujos, suskystintos

not available LT/1/11/2556/001 UAB ELME MESSER LIT LT

Medische distikstofoxide Messer Belgium, 100 % v/v, medicinaal gas, vloeibaar gemaakt

not available BE187327 MESSER BELGIUM N.V. BE

List of nationally authorised medicinal products EMA/173529/2019 Page 6/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Medische distikstofoxide Messer Belgium, 100 % v/v, medicinaal gas, vloeibaar gemaakt

not available BE226091 MESSER BELGIUM N.V. BE

Mediciniskais slapekla oksiduls ELME MESSER L 100% mediciniska gaze, saskidrinata

not available 12-0123 ELME MESSER L SIA LV

PROTOXYDE D'AZOTE MEDICINAL SOL FRANCE, gaz pour inhalation en bouteille

not available 562 549-5 SOL FRANCE FR

PROTOXYDE D'AZOTE MEDICINAL SOL FRANCE, gaz pour inhalation en bouteille

not available 562 550-3 SOL FRANCE FR

PROTOXYDE D'AZOTE MEDICINAL SOL FRANCE, gaz pour inhalation en bouteille

not available 562 552-6 SOL FRANCE FR

PROTOXYDE D'AZOTE MEDICINAL SOL FRANCE, gaz pour inhalation en bouteille

not available 562 553-2 SOL FRANCE FR

List of nationally authorised medicinal products EMA/173529/2019 Page 7/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PROTOXYDE D'AZOTE MEDICINAL SOL FRANCE, gaz pour inhalation en bouteille

not available 562 554-9 SOL FRANCE FR

PROTOXYDE D'AZOTE MEDICINAL SOL FRANCE, gaz pour inhalation en bouteille

not available 562 555-5 SOL FRANCE FR

PROTOXYDE D'AZOTE MEDICINAL SOL FRANCE, gaz pour inhalation en bouteille

not available 563 409-2 SOL FRANCE FR

PROTOXYDE D'AZOTE MEDICINAL SOL FRANCE, gaz pour inhalation en bouteille

not available 582 267-5 SOL FRANCE FR

Protóxido de nitrógeno medicinal Messer, gas para inhalación, en botella.

not available 67443 MESSER IBÉRICA DE GASES S.A.U.

ES

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/09 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

List of nationally authorised medicinal products EMA/173529/2019 Page 8/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/01 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/02 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/03 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/04 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/05 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/06 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/07 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

Dinitrogén-oxid Bus-Oxy 100 v/v % cseppfolyósított orvosi gáz

not available OGYI-T-22411/08 BUS-OXY EGÉSZSÉGÜGYI GÁZFORGALMAZÓ KFT.

HU

List of nationally authorised medicinal products EMA/173529/2019 Page 9/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Distikstofoxide medicinaal AIR PRODUCTS, 100% v/v, medicinaal gas, vloeibaar gemaakt

not available BE190924 AIR PRODUCTS S.A/N.V. BE

Distickstoff Oxid AIR PRODUCTS, 100% v/v, Gas für medizinische Zwecke, verflüssigt

not available BE226082 AIR PRODUCTS S.A/N.V. BE

Distickstoff Oxid AIR PRODUCTS, 100% v/v, Gas für medizinische Zwecke, verflüssigt

not available BE226073 AIR PRODUCTS S.A/N.V. BE

PROTÓXIDO DE NITRÓGENO MEDICINAL CARBUROS METÁLICOS, Gas para inhalación, 98,0% v/v, en botellas

not available 67409 S.E. CARBUROS METÁLICOS, S.A.

ES

Oxid dusný medicinálny AIR PRODUCTS 100 % V/V plyn na inhaláciu

NL/H/0862/001 05/0569/10-S AIR PRODUCTS SLOVAKIA S R. O.

SK

Distikstofoxide medicinaal AIR PRODUCTS, 100% v/v, medicinaal gas, vloeibaar gemaakt

NL/H/0862/001 RVG 32959 AIR PRODUCTS NEDERLAND B.V.

NL

List of nationally authorised medicinal products EMA/173529/2019 Page 10/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Oxid dusný medicinální AIR PRODUCTS 100% v/v, plyn pro inhalaci, zkapalněný

NL/H/0862/001 89/472/09-C AIR PRODUCTS SPOL. S.R.O. CZ

Protóxido de azoto Medicinal Gasoso Gasin, 100%vv, gás medicinal liquefeito

NL/H/0862/001 5193057 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Protóxido de azoto Medicinal Gasoso Gasin, 100%vv, gás medicinal liquefeito

NL/H/0862/001 5193040 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Podtlenek azotu AIR PRODUCTS, 100% v/v, gaz medyczny skroplony

NL/H/0862/001 20170 AIR PRODUCTS SP. Z.O.O. PL

Dinitrogén-oxid Air Products cseppfolyósított orvosi gáz

NL/H/0862/001 OGYI-T-22203/01 TO OGYI-T-22203/58.

AIR PRODUCTS SPOL. S.R.O. HU

Medicinal nitrous oxide SIAD Medicinal gas, liquefied

CZ/H/0301/001 05/614/08-C SIAD CZECH SPOL.S.R.O. CZ

Dinitrogén-oxid SIAD cseppfolyósított orvosi gáz

CZ/H/0301/001 OGYI-T-21703/01 SIAD HUNGARY GÁZOKAT FORGALMAZÓ ÉS TERMELŐ KFT.

HU

List of nationally authorised medicinal products EMA/173529/2019 Page 11/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Dinitrogén-oxid SIAD cseppfolyósított orvosi gáz

CZ/H/0301/001 OGYI-T-21703/02 SIAD HUNGARY GÁZOKAT FORGALMAZÓ ÉS TERMELŐ KFT.

HU

Dinitrogén-oxid SIAD cseppfolyósított orvosi gáz

CZ/H/0301/001 OGYI-T-21703/03 SIAD HUNGARY GÁZOKAT FORGALMAZÓ ÉS TERMELŐ KFT.

HU

Dinitrogén-oxid SIAD cseppfolyósított orvosi gáz

CZ/H/0301/001 OGYI-T-21703/04 SIAD HUNGARY GÁZOKAT FORGALMAZÓ ÉS TERMELŐ KFT.

HU

Medicinálny oxid dusný SIAD medicinálny plyn skvapalnený

CZ/H/0301/001 05/0007/11-S SIAD SLOVAKIA SPOL. S R.O. SK

Medicinal nitrous oxide SIAD, Medicinal gas, liquefied

CZ/H/301/01-04 8063/2015/01-02-03-04 SIAD ROMANIA SRL RO

Protoxid de azot medicinal SIAD gaz medicinal, lichefiat

CZ/H/0301/001 8063/2015/01 SIAD ROMANIA SRL RO

Protoxid de azot medicinal SIAD gaz medicinal, lichefiat

CZ/H/0301/001 8063/2015/02 SIAD ROMANIA SRL RO

Protoxid de azot medicinal SIAD gaz medicinal, lichefiat

CZ/H/0301/001 8063/2015/03 SIAD ROMANIA SRL RO

List of nationally authorised medicinal products EMA/173529/2019 Page 12/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Protoxid de azot medicinal SIAD gaz medicinal, lichefiat

CZ/H/0301/001 8063/2015/04 SIAD ROMANIA SRL RO

Podtlenek azotu SIAD, gaz medyczny skroplony

CZ/H/0301/001 23145 SIAD CZECH SPOL.S.R.O. PL

Protoxan 50%/50% gas comprimido medicinal

SE/H/1274/001 77884 PRAXAIR ESPAÑA, S.L. ES

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646012 RIVOIRA S.P.A. IT

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646024 RIVOIRA S.P.A. IT

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646036 RIVOIRA S.P.A. IT

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646048 RIVOIRA S.P.A. IT

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646051 RIVOIRA S.P.A. IT

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646063 RIVOIRA S.P.A. IT

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646075 RIVOIRA S.P.A. IT

List of nationally authorised medicinal products EMA/173529/2019 Page 13/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646087 RIVOIRA S.P.A. IT

Protoxan 50%/50%, gas medicinale, compresso

SE/H/1274/001 042646099 RIVOIRA S.P.A. IT

Protoxan 50% + 50% gás medicinal comprimido

SE/H/1274/001 5571021 PRAXAIR PORTUGAL GASES S.A.

PT

Protoxan 50% + 50% gás medicinal comprimido

SE/H/1274/001 5571039 PRAXAIR PORTUGAL GASES S.A.

PT

Protoxan 50% + 50% gás medicinal comprimido

SE/H/1274/001 5571047 PRAXAIR PORTUGAL GASES S.A.

PT

Protoxan 50% + 50% gás medicinal comprimido

SE/H/1274/001 5571054 PRAXAIR PORTUGAL GASES S.A.

PT

Protoxan 50% + 50% gás medicinal comprimido

SE/H/1274/001 5571062 PRAXAIR PORTUGAL GASES S.A.

PT

Protoxan 50%/50% Gas zur medizinischen Anwendung, druckverdichtet

SE/H/1274/01/DC 87872.00.00 PRAXAIR DEUTSCHLAND GMBH DE

Protoxan 50 % / 50 %, medicinsk gas, komprimerad

SE/H/1274/001 47884 YARA PRAXAIR HOLDING AS SE

List of nationally authorised medicinal products EMA/173529/2019 Page 14/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Medicinsk lustgas Yara Praxair 100 %, medicinsk gas, flytande

SE/H/0659/001 24847 YARA PRAXAIR HOLDING AS SE

Medicinsk lustgas Yara Praxair 100 %, medicinsk gas, flytande

SE/H/0659/001 24847 YARA PRAXAIR HOLDING AS SE

Medicinsk lustgas Yara Praxair 100 %, medicinsk gas, flytande

SE/H/0659/001 24847 YARA PRAXAIR HOLDING AS SE

Medicinsk lustgas Yara Praxair 100 %, medicinsk gas, flytande

SE/H/0659/001 24847 YARA PRAXAIR HOLDING AS SE

Medicinsk lustgas Yara Praxair 100 %, medicinsk gas, flytande

SE/H/0659/001 24847 YARA PRAXAIR HOLDING AS SE

Medicinsk lustgas Yara Praxair 100 %, medicinsk gas, flytande

SE/H/0659/001 24847 YARA PRAXAIR HOLDING AS SE

Medicinsk lustgas Yara Praxair 100 %, medicinsk gas, flytande

SE/H/0659/001 24847 YARA PRAXAIR HOLDING AS SE

Medisinsk lystgass Yara Praxair 100 % medisinsk gass, flytende

SE/H/0659/001 06-4613 YARA PRAXAIR HOLDING AS NO

List of nationally authorised medicinal products EMA/173529/2019 Page 15/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Medisinsk lystgass Yara Praxair 100 % medisinsk gass, flytende

SE/H/0659/001 06-4613 YARA PRAXAIR HOLDING AS NO

Medisinsk lystgass Yara Praxair 100 % medisinsk gass, flytende

SE/H/0659/001 06-4613 YARA PRAXAIR HOLDING AS NO

Medisinsk lystgass Yara Praxair 100 % medisinsk gass, flytende

SE/H/0659/001 06-4613 YARA PRAXAIR HOLDING AS NO

Medisinsk lystgass Yara Praxair 100 % medisinsk gass, flytende

SE/H/0659/001 06-4613 YARA PRAXAIR HOLDING AS NO

Medisinsk lystgass Yara Praxair 100 % medisinsk gass, flytende

SE/H/0659/001 06-4613 YARA PRAXAIR HOLDING AS NO

Medisinsk lystgass Yara Praxair 100 % medisinsk gass, flytende

SE/H/0659/001 06-4613 YARA PRAXAIR HOLDING AS NO

Medicinsk dinitrogenoxid ”Yara Praxair” 100 %, medicinsk gas, flydende

SE/H/0659/001 40475 YARA PRAXAIR HOLDING AS DK

Medicinsk dinitrogenoxid ”Yara Praxair” 100 %, medicinsk gas, flydende

SE/H/0659/001 40475 YARA PRAXAIR HOLDING AS DK

List of nationally authorised medicinal products EMA/173529/2019 Page 16/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Medicinsk dinitrogenoxid ”Yara Praxair” 100 %, medicinsk gas, flydende

SE/H/0659/001 40475 YARA PRAXAIR HOLDING AS DK

Medicinsk dinitrogenoxid ”Yara Praxair” 100 %, medicinsk gas, flydende

SE/H/0659/001 40475 YARA PRAXAIR HOLDING AS DK

Medicinsk dinitrogenoxid ”Yara Praxair” 100 %, medicinsk gas, flydende

SE/H/0659/001 40475 YARA PRAXAIR HOLDING AS DK

Medicinsk dinitrogenoxid ”Yara Praxair” 100 %, medicinsk gas, flydende

SE/H/0659/001 40475 YARA PRAXAIR HOLDING AS DK

Medicinsk dinitrogenoxid ”Yara Praxair” 100 %, medicinsk gas, flydende

SE/H/0659/001 40475 YARA PRAXAIR HOLDING AS DK

Niontix 100%, lyfjagas, fljótandi

SE/H/0724/001 IS/1/07/032/01 AGA AB, LINDE HEALTHCARE IS

Niontix 100 % medisinsk gass, flytende

SE/H/0724/001 07-4799 AGA AB, LINDE HEALTHCARE NO

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/001 AGA AB, LINDE HEALTHCARE LT

List of nationally authorised medicinal products EMA/173529/2019 Page 17/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/002 AGA AB, LINDE HEALTHCARE LT

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/003 AGA AB, LINDE HEALTHCARE LT

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/004 AGA AB, LINDE HEALTHCARE LT

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/005 AGA AB, LINDE HEALTHCARE LT

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/006 AGA AB, LINDE HEALTHCARE LT

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/007 AGA AB, LINDE HEALTHCARE LT

NIONTIX 100 % suskystintosios medicininės dujos

SE/H/0724/001 LT/1/07/0866/008 AGA AB, LINDE HEALTHCARE LT

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/009 AGA AB, LINDE HEALTHCARE LT

List of nationally authorised medicinal products EMA/173529/2019 Page 18/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/010 AGA AB, LINDE HEALTHCARE LT

NIONTIX 100 % suskystintosios medicinines dujos

SE/H/0724/001 LT/1/07/0866/011 AGA AB, LINDE HEALTHCARE LT

Niontix 100 % mediciniska gaze, saškidrinata

SE/H/0724/001 07-0339 AGA AB, LINDE HEALTHCARE LV

Niontix 100 %, medicinsk gas, flytande

SE/H/0724/001 19004 AGA AB, LINDE HEALTHCARE SE

NIONTIX 100%, lääkkeellinen kaasu, nesteytetty

SE/H/0724/001 23304 AGA AB, LINDE HEALTHCARE FI

Niontix, 100% meditsiiniline gaas, veeldatud

SE/H/0724/001 552707 AGA AB, LINDE HEALTHCARE EE

Niontix, flydende medicinsk gas

SE/H/0724/001 40848 AGA AB, LINDE HEALTHCARE DK

Antafil 50%/50% v/v, gaz médicinal comprimé

NL/H/2233/001 BE424426 SOL SPA BE

Antafil 50%/50% v/v, gaz médicinal comprimé

NL/H/2233/001 BE424435 SOL SPA BE

List of nationally authorised medicinal products EMA/173529/2019 Page 19/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Antafil 50%/50% v/v, gaz médicinal comprimé

NL/H/2233/001 2012100084 SOL SPA LU

Donopa 50 %/50 % Gas zur medizinischen Anwendung, druckverdichtet

NL/H/2233/001 84903.00.00 SOL SPA DE

Donopa 50%/50% v/v medicinaal gas, samengeperst

NL/H/2233/001 RVG 109415 SOL SPA NL

Donopa 50%/50% v/v medicinal gas, compressed

NL/H/2233/001 PL 35326/0009 SOL SPA UK

Antafil 50%/50% v/v medicinaal gas, samengeperst

NL/H/2233/001 BE424435 SOL SPA BE

Antafil 50%/50% v/v medicinaal gas, samengeperst

NL/H/2233/001 BE424426 SOL SPA BE

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095011 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095023 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095035 SOL SPA IT

List of nationally authorised medicinal products EMA/173529/2019 Page 20/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095047 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095050 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095062 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095074 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095086 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095098 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095100 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095112 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095124 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095136 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095148 SOL SPA IT

List of nationally authorised medicinal products EMA/173529/2019 Page 21/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095151 SOL SPA IT

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001 041095163 SOL SPA IT

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/01 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/02 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/03 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/04 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/05 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/06 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OLGI-T-23041/07 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/08 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/09 SOL SPA HU

List of nationally authorised medicinal products EMA/173529/2019 Page 22/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/10 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/11 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/12 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/13 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/14 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/15 SOL SPA HU

Donopa 50%/50% v/v túlnyomásos orvosi gáz

NL/H/2233/001 OGYI-T-23041/16 SOL SPA HU

Donopa, 50 %/50 % v/v, medicinal gas, compressed

NL/H/2233/001 PA1848/003/001 SOL SPA IE

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/001 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/002 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/003 SOL SPA SI

List of nationally authorised medicinal products EMA/173529/2019 Page 23/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/004 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/005 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/006 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/007 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/008 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/009 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/010 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/011 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/012 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/013 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/014 SOL SPA SI

List of nationally authorised medicinal products EMA/173529/2019 Page 24/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/015 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/016 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/017 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/018 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/019 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/020 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/021 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/022 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/023 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/024 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/025 SOL SPA SI

List of nationally authorised medicinal products EMA/173529/2019 Page 25/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/026 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/027 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/028 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/029 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/030 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/031 SOL SPA SI

Donopa, 50 %/50 % v/v, medicinski plin, stisnjeni

NL/H/2233/001 H/16/02213/032 SOL SPA SI

Donopa 50%/50% V/V, medicinski plin, stlačen

NL/H/2233/001 HR-H-796602530 SOL SPA HR

Donopa 50%/50% V/V, medicinski plin, stlačen

NL/H/2233/001 HR-H-796602530 SOL SPA HR

Donopa 50%/50% V/V, medicinski plin, stlačen

NL/H/2233/001 HR-H-796602530 SOL SPA HR

Donopa 50%/50% V/V, medicinski plin, stlačen

NL/H/2233/001 HR-H-796602530 SOL SPA HR

List of nationally authorised medicinal products EMA/173529/2019 Page 26/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Donopa 50%/50% V/V, medicinski plin, stlacen

NL/H/2233/001 HR-H-796602530 SOL SPA HR

Donopa 50%/50% V/V, medicinski plin, stlacen

NL/H/2233/001 HR-H-796602530 SOL SPA HR

Donopa 50%/50% V/V, medicinski plin, stlačen

NL/H/2233/001 HR-H-796602530 SOL SPA HR

Donopa 50%/50% V/V, medicinski plin, stlacen

NL/H/2233/001 HR-H-796602530 SOL SPA HR

Donopa 50%/50% v/v medicinal gas, compressed

NL/H/2233/001/DC 20160332 SOL SPA BG

Donopa 50%/50% v/v gas medicinale compresso

NL/H/2233/001/DC 137455 SOL SPA AT

NIONTIX 100 % Gás medicinal liquefeito

not available 5092259 LINDE PORTUGAL LDA PT

NIONTIX 100 % Gás medicinal liquefeito

not available 5092267 LINDE PORTUGAL LDA PT

NIONTIX 100 % Gás medicinal liquefeito

not available 5092275 LINDE PORTUGAL LDA PT

NIONTIX 100 % Gás medicinal liquefeito

not available 5092341 LINDE PORTUGAL LDA PT

NIONTIX 100 % Gás medicinal liquefeito

not available 5168125 LINDE PORTUGAL LDA PT

List of nationally authorised medicinal products EMA/173529/2019 Page 27/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

NIONTIX 100 % Gás medicinal liquefeito

not available 5092242 LINDE PORTUGAL LDA PT

NIONTIX 100 % Gás medicinal liquefeito

not available 5655345 LINDE PORTUGAL LDA PT

NIONTIX 100 % Gás medicinal liquefeito

not available 5655337 LINDE PORTUGAL LDA PT

NIONTIX 100 % Gás medicinal liquefeito

not available 5677513 LINDE PORTUGAL LDA PT

MEDICINÁLNÍ OXID DUSNÝ MESSER Medicinální plyn, zkapalnený

not available 89/691/08-C MESSER TECHNOGAS S.R.O. CZ

ÓXIDO NITROSO MEDICINAL LÍQUIDO LINDE, 98,0% gas para inhalación en Recipiente Criogénico Móvil.

not available 67445 ABELLO LINDE, S.A. ES

Medical Nitrous Oxide not available PA 208/1/1 BOC GASES IRELAND LTD IE

Stickoxydul medizinisch Siad Austria

not available 1-26104 SIAD AUSTRIA GMBH AT

OXIDO NITROSO MEDICINAL LÍQUIDO OXIGEN SALUD, 98,0%, gas para inhalación

not available 68345 OXIGEN SALUD S.A. ES

List of nationally authorised medicinal products EMA/173529/2019 Page 28/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

ÓXIDO NITROSO MEDICINAL LÍQUIDO LINDE, 98,0% gas para inhalación en Recipiente Criogénico Fijo

not available 69895 ABELLO LINDE, S.A. ES

PODTLENEK AZOTU N2O gaz medyczny

not available 8122 LINDE GAZ POLSKA SP. Z O.O. PL

Entonox not available PL 00735 / 5017R BOC LTD UK

DINITROX, 100% v/v, medicinaal gas, vloeibaar gemaakt

not available BE218793 AIR PRODUCTS S.A/N.V. BE

DINITROX, 100% v/v, gaz liquide à usage médical

not available BE218793 AIR PRODUCTS S.A/N.V. BE

DINITROX, 100% v/v, medicinaal gas, vloeibaar gemaakt

not available BE218802 AIR PRODUCTS S.A/N.V. BE

DINITROX, 100% v/v, gaz liquide à usage médical

not available BE218802 AIR PRODUCTS S.A/N.V. BE

Entonox 50%/50% gaz medicinal comprimat

SE/H/0831/001 5707/2013/03 AGA AB, LINDE HEALTHCARE RO

Entonox 50%/50% gaz medicinal comprimat

SE/H/0831/001 5707/2013/04 AGA AB, LINDE HEALTHCARE RO

List of nationally authorised medicinal products EMA/173529/2019 Page 29/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Entonox 50%/50% gaz medicinal comprimat

SE/H/0831/001 5707/2013/05 AGA AB, LINDE HEALTHCARE RO

Entonox 50%/50% gaz medicinal comprimat

SE/H/0831/001 5707/2013/06 AGA AB, LINDE HEALTHCARE RO

Entonox 50%/50% gaz medicinal comprimat

SE/H/0831/001 5707/2013/07 AGA AB, LINDE HEALTHCARE RO

Entonox 50%/50% gaz medicinal comprimat

SE/H/0831/001 5707/2013/08 AGA AB, LINDE HEALTHCARE RO

Livopan 50%/50% lyfjagas, undir þrýstingi

SE/H/0831/001 IS/1/08/039/01 AGA AB, LINDE HEALTHCARE IS

LIVOPAN 50 % / 50 % medisinsk gass, komprimert

SE/H/0831/001 07-5598 AGA AB, LINDE HEALTHCARE NO

Livopan 50% + 50%, gás medicinal comprimido

SE/H/0831/001 5192836 AGA AB, LINDE HEALTHCARE PT

Livopan 50% + 50%, gás medicinal comprimido

SE/H/0831/001 5192844 AGA AB, LINDE HEALTHCARE PT

Livopan 50% + 50%, gás medicinal comprimido

SE/H/0831/001 5192851 AGA AB, LINDE HEALTHCARE PT

ENTONOX 50%/50% meditsiiniline surugaas

SE/H/0831/001 846714 AGA AB, LINDE HEALTHCARE EE

List of nationally authorised medicinal products EMA/173529/2019 Page 30/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Entonox 50%/50% medicīniskā gāze, saspiesta

SE/H/0831/001 14-0155 AGA AB, LINDE HEALTHCARE LV

ENTONOX 50 % / 50 % suslegtosios medicinines dujos

SE/H/0831/001 LT/1/14/3586/003 AGA AB, LINDE HEALTHCARE LT

ENTONOX 50 % / 50 % suslegtosios medicinines dujos

SE/H/0831/001 LT/1/14/3586/004 AGA AB, LINDE HEALTHCARE LT

ENTONOX 50 % / 50 % suslegtosios medicinines dujos

SE/H/0831/001 LT/1/14/3586/005 AGA AB, LINDE HEALTHCARE LT

ENTONOX 50 % / 50 % suslegtosios medicinines dujos

SE/H/0831/001 LT/1/14/3586/006 AGA AB, LINDE HEALTHCARE LT

ENTONOX 50 % / 50 % suslegtosios medicinines dujos

SE/H/0831/001 LT/1/14/3586/007 AGA AB, LINDE HEALTHCARE LT

ENTONOX 50 % / 50 % suslegtosios medicinines dujos

SE/H/0831/001 LT/1/14/3586/008 AGA AB, LINDE HEALTHCARE LT

Entonox 50%/50%, medicinální plyn stlacený

SE/H/0831/001 89/822/10-C AGA AB, LINDE HEALTHCARE CZ

List of nationally authorised medicinal products EMA/173529/2019 Page 31/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

ENTONOX 50 %/50 %, medicinálny plyn stlačený

SE/H/0831/001 05/0628/10-S AGA AB, LINDE HEALTHCARE SK

Entonox 50%/50% gas medicinal comprimido

SE/H/0831/001 71597 AGA AB, LINDE HEALTHCARE ES

ENTONOX 50%/50% φαρμακευτικό αέριο, συμπιεσμένο.

SE/H/0831/001 20895 AGA AB, LINDE HEALTHCARE CY

Entonox, 50% + 50%, gaz medyczny spręžony

SE/H/0831/001 16433 AGA AB, LINDE HEALTHCARE PL

LIVOPAN 50 %/ 50 % Gas zur medizinischen Anwendung, druckverdichtet

SE/H/0831/001 1-27658 AGA AB, LINDE HEALTHCARE AT

Livopan 50 % / 50 % lääkkeellinen kaasu, puristettu

SE/H/0831/001 24534 AGA AB, LINDE HEALTHCARE FI

Livopan 50%/50% túlnyomásos orvosi gáz

SE/H/0831/001 OGYI-T-21676/03 AGA AB, LINDE HEALTHCARE HU

Livopan 50%/50% túlnyomásos orvosi gáz

SE/H/0831/001 OGYI-T-21676/04 AGA AB, LINDE HEALTHCARE HU

Livopan 50%/50% túlnyomásos orvosi gáz

SE/H/0831/001 OGYI-T-21676/05 AGA AB, LINDE HEALTHCARE HU

List of nationally authorised medicinal products EMA/173529/2019 Page 32/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Livopan 50%/50% túlnyomásos orvosi gáz

SE/H/0831/001 OGYI-T-21676/06 AGA AB, LINDE HEALTHCARE HU

Livopan 50%/50% túlnyomásos orvosi gáz

SE/H/0831/001 OGYI-T-21676/07 AGA AB, LINDE HEALTHCARE HU

Livopan 50%/50% túlnyomásos orvosi gáz

SE/H/0831/001 OGYI-T-21676/08 AGA AB, LINDE HEALTHCARE HU

Livopan 50%/50% Gas Medicinale Compresso

SE/H/0831/001 039444017 AGA AB, LINDE HEALTHCARE IT

Livopan 50%/50% Gas Medicinale Compresso

SE/H/0831/001 039444029 AGA AB, LINDE HEALTHCARE IT

Livopan 50%/50% Gas Medicinale Compresso

SE/H/0831/001 039444082 AGA AB, LINDE HEALTHCARE IT

Livopan 50%/50% Gas Medicinale Compresso

SE/H/0831/001 039444056 AGA AB, LINDE HEALTHCARE IT

Livopan 50%/50% Gas Medicinale Compresso

SE/H/0831/001 039444068 AGA AB, LINDE HEALTHCARE IT

Livopan 50%/50% Gas Medicinale Compresso

SE/H/0831/001 039444031 AGA AB, LINDE HEALTHCARE IT

Livopan 50%/50% Gas Medicinale Compresso

SE/H/0831/001 039444070 AGA AB, LINDE HEALTHCARE IT

Livopan 50%/50% Gas Medicinale Compresso

SE/H/0831/001 039444043 AGA AB, LINDE HEALTHCARE IT

List of nationally authorised medicinal products EMA/173529/2019 Page 33/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Livopan, 50%/50% medicinsk gas, komprimerad

SE/H/0831/001 23301 AGA AB, LINDE HEALTHCARE SE

Livopan, medicinsk gas, komprimeret

SE/H/0831/001 42644 AGA AB, LINDE HEALTHCARE DK

LIVOPAN 50 % / 50 % Gas zur medizinischen Anwendung, druckverdichtet Wirkstoffe: Distickstoffmonoxid / Sauerstoff

SE/H/0831/001 72546.00.00 AGA AB, LINDE HEALTHCARE DE

Relivopan 50 %/50 %, gaz médical comprimé

SE/H/0831/001 BE 318613 AGA AB, LINDE HEALTHCARE BE

Relivopan 50%/50% medicinaal gas, samengeperst

SE/H/0831/001 BE 318613 AGA AB, LINDE HEALTHCARE BE

RELIVOPAN 50 %/50 % Gas zur medizinischen Anwendung, druckverdichtet

SE/H/0831/001 2008060024 AGA AB, LINDE HEALTHCARE LU

RELIVOPAN 50 %/50 %, gaz médical comprimé

SE/H/0831/001 2008060024 AGA AB, LINDE HEALTHCARE LU

List of nationally authorised medicinal products EMA/173529/2019 Page 34/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Relivopan 50%/50% medicinaal gas, samengeperst

SE/H/0831/001 2008060024 AGA AB, LINDE HEALTHCARE LU

Relivopan 50%/50% medicinaal gas, samengeperst

SE/H/0831/001 RVG 101685 AGA AB, LINDE HEALTHCARE NL

ENTONOX 50%/50% φαρμακευτικό αέριο, συμπιεσμένο.

SE/H/0831/001 59465 / 29-08-2016 AGA AB, LINDE HEALTHCARE GR

Distickstoffmonoxid für medizinische Zwecke

not available 2349.99.99 WESTFALEN AG DE

Entonox not available PA 0208/005/001 BOC GASES IRELAND LTD IE

Nitronox Inhalation Gas not available PL 17872/0001 MEDICAL GAS SOLUTIONS LTD UK

Medicinsk Dinitrogenoxid ”Strandmøllen”, flydende medicinsk gas

IS/H/0124/001 42683 STRANDMØLLEN A/S DK

Medicinsk Lustgas Strandmollen 100 %, medicinsk gas, flytande

IS/H/0124/001 26532 STRANDMØLLEN A/S SE

Lyfjatvíköfnunarefnisoxíð Strandmøllen 100%, lyfjagas, fljótandi

IS/H/0124/001 IS/1/08/191/01 STRANDMØLLEN A/S IS

List of nationally authorised medicinal products EMA/173529/2019 Page 35/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Distickstoffmonoxid Strandmöllen 100 % Gas zur medizinischen Anwendung, verflüssigt

IS/H/0124/001 89306.00.00 STRANDMØLLEN A/S DE

ENTONOX 170 bar, gaz pour inhalation, en bouteille

not available 34009 224 107 3 9 LINDE FRANCE S.A. FR

ENTONOX 170 bar, gaz pour inhalation, en bouteille

not available 34009 224 109 6 8 LINDE FRANCE S.A. FR

ENTONOX 170 bar, gaz pour inhalation, en bouteille

not available 34009 582 958 8 1 LINDE FRANCE S.A. FR

ENTONOX 135 bar, gaz pour inhalation, en bouteille

not available 34009 562 160 0 0 LINDE FRANCE S.A. FR

ENTONOX 135 bar, gaz pour inhalation, en bouteille

not available 34009 562 161 7 8 LINDE FRANCE S.A. FR

ENTONOX 135 bar, gaz pour inhalation, en bouteille

not available 34009 396 421 8 5 LINDE FRANCE S.A. FR

List of nationally authorised medicinal products EMA/173529/2019 Page 36/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

ENTONOX 135 bar, gaz pour inhalation, en bouteille

not available 34009 565 099 0 4 LINDE FRANCE S.A. FR

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294018 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294032 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294020 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294057 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294069 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294044 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294071 LINDE MEDICALE SRL IT

List of nationally authorised medicinal products EMA/173529/2019 Page 37/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294083 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294095 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294107 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294119 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294121 LINDE MEDICALE SRL IT

AZOTO PROTOSSIDO LINDE MEDICALE gas medicinale liquefatto

not available 039294133 LINDE MEDICALE SRL IT

STICKOXYDUL medizinisch MESSER

not available 1-26099 MESSER AUSTRIA GMBH AT

Stickoxydul medizinisch MESSER

not available 2349.99.99 MESSER INDUSTRIEGASE GMBH

DE

Medical Nitrous Oxide not available PL 00735/5001R BOC LTD UK

List of nationally authorised medicinal products EMA/173529/2019 Page 38/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Lääkkeellinen ilokaasu AWO 100 %, lääkkeellinen kaasu, nesteytetty

not available 24588 OY WOIKOSKI AB FI

Lääkkeellinen ilokaasu AWO 100 %, medicinsk gas, flytande

not available 24588 OY WOIKOSKI AB FI

Диазотен оксид Messer 100% v/v втечнен медицински газ

NL/H/2606/001 20130215 MESSER BULGARIA EOOD BG

Oxid dusný Messer 100% medicinálny plyn, skvapalnený

NL/H/2606/001 05/0315/13-S MESSER TATRAGAS, SPOL. S R.O.

SK

Lachgas Messer 100% v/v medicinaal gas, vloeibaar gemaakt

NL/H/2606/001/DC RVG 111763 MESSER BELGIUM N.V. NL

Distikstofoxide Messer 100% v/v, medicinaal gas, vloeibaar gemaakt

NL/H/2606/001/DC BE437902 MESSER BELGIUM N.V. BE

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001/DC 10730/2018/01 MESSER ROMANIA GAZ SRL RO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Distickstoffmonoxid Messer 100% Gas zur medizinischen Anwendung, verflüssigt

not available 87373.00.00 MESSER INDUSTRIEGASE GMBH

DE

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/06 MESSER ROMANIA GAZ SRL RO

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/05 MESSER ROMANIA GAZ SRL RO

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/04 MESSER ROMANIA GAZ SRL RO

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/03 MESSER ROMANIA GAZ SRL RO

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/02 MESSER ROMANIA GAZ SRL RO

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/10 MESSER ROMANIA GAZ SRL RO

List of nationally authorised medicinal products EMA/173529/2019 Page 40/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/09 MESSER ROMANIA GAZ SRL RO

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/08 MESSER ROMANIA GAZ SRL RO

Protoxid de azot Messer 100% gaz medicinal lichefiat

NL/H/2606/001 10730/2018/07 MESSER ROMANIA GAZ SRL RO

PROTÓXIDO DE NITRÓGENO MEDICINAL PRAXAIR, gas para inhalación, en recipiente criogénico fijo

not available 67387 PRAXAIR ESPAÑA, S.L. ES

STICKOXYDUL medizinisch LINDE

not available 1-26093 LINDE GAS GMBH AT

Distickstoffmonoxid medicAL 100 % (V/V) Gas zur medizinischen Anwendung, druckverdichtet

not available 6196262.00.00 AIR LIQUIDE MEDICAL GMBH DE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PROTOXYDE D'AZOTE MEDICINAL AIR PRODUCTS MEDICAL, gaz pour inhalation, en bouteille

not available NL 21820 AIR PRODUCTS S.A.S FR

ANTASOL 180, gaz pour inhalation, en bouteille

not available 417 797-1 SOL FRANCE FR

ANTASOL 180, gaz pour inhalation, en bouteille

not available 417 798-8 SOL FRANCE FR

Protoxyde d’Azote Médicinal Praxair, 100 % v/v, gaz médical liquéfié

PT/H/0377/001 BE516186 PRAXAIR NV BE

Medisch Distikstofoxide Praxair, 100 % v/v, medicinaal gas, vloeibaar gemaakt

PT/H/0377/001 BE516186 PRAXAIR NV BE

Distickstoffmonoxid Praxair 100 % Gas zur medizinischen Anwendung, verflüssigt

PT/H/0377/001 2200178.00.00 PRAXAIR DEUTSCHLAND GMBH DE

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145412 PRAXAIR PORTUGAL GASES S.A.

PT

List of nationally authorised medicinal products EMA/173529/2019 Page 42/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145420 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145438 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145446 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145453 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145461 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145479 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145503 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145511 PRAXAIR PORTUGAL GASES S.A.

PT

List of nationally authorised medicinal products EMA/173529/2019 Page 43/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145529 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145537 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145545 PRAXAIR PORTUGAL GASES S.A.

PT

Protóxido de Azoto Medicinal Praxair, Gás para inalação, 100%

not available 5145552 PRAXAIR PORTUGAL GASES S.A.

PT

Distickstoffmonoxid für medizinische Zwecke Gas zur medizinischen Anwendung, verflüssigt

not available 2349.99.99 RIESSNER GASE GMBH DE

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-869/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-870/13 SOL SPA SI

List of nationally authorised medicinal products EMA/173529/2019 Page 44/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-871/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-872/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-873/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-874/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-875/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-876/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-877/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-878/13 SOL SPA SI

List of nationally authorised medicinal products EMA/173529/2019 Page 45/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-879/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-880/13 SOL SPA SI

Medicinski didušikov oksid SOL 100 % medicinski plin, utekočinjen

NL/H/2783/001 5363-I-881/13 SOL SPA SI

Nitrous oxide 100 % v/v medicinal gas, liquefied

NL/H/2783/001 PL 35326/0010 SOL SPA UK

Protoxyde d’azote Médicinal SOL 100 % v/v, gaz médicinal liquéfié

NL/H/2783/01/MR BE433596 SOL SPA BE

Distikstofoxide Medicinaal SOL, 100% v/v, medicinaal gas, vloeibaar gemaakt

NL/H/2783/001 BE433596 SOL SPA BE

Protoxyde d’azote Médicinal SOL 100 % v/v, gaz médicinal liquéfié

NL/H/2783/001 2013060233 SOL SPA LU

Медицински диазотен оксид SOL 100 % v/v втечнен медицински газ

NL/H/2783/001 20130114 SOL SPA BG

List of nationally authorised medicinal products EMA/173529/2019 Page 46/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Nitrous oxide Medicinal SOL, 100 % v/v, medicinal gas, liquefied

NL/H/2783/001 PA1848/004/001 SOL SPA IE

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200101 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200102 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200103 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200104 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200105 SOL SPA GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200106 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200107 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200108 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200110 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200111 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200112 SOL SPA GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200113 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200114 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200115 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200116 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200117 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200118 SOL SPA GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200119 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200120 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200121 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200122 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200123 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200124 SOL SPA GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200125 SOL SPA GR

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200126 SOL SPA GR

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/01 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/02 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/03 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/04 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/05 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/06 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/07 SOL SPA RO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/08 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/09 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/10 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/11 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/12 SOL SPA RO

Protoxid de azot SOL 100 % gaz medicinal lichefiat

NL/H/2783/001 9334/2016/13 SOL SPA RO

OXIDO NITROSO MEDICINAL SOLGROUP 100% V/V GAS LICUADO MEDICINAL

NL/H/2783/001/E/001 713156 - 4 SOL SPA ES

OXIDO NITROSO MEDICINAL SOLGROUP 100% V/V GAS LICUADO MEDICINAL

NL/H/2783/001/E/001 713161 - 8 SOL SPA ES

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

OXIDO NITROSO MEDICINAL SOLGROUP 100% V/V GAS LICUADO MEDICINAL

NL/H/2783/001/E/001 713163 - 2 SOL SPA ES

Φαρμακευτικό Πρωτοξείδιο του Αζώτου SOL, 100% v/v, ιατρικό αέριο, υγροποιημένο

NL/H/2783/001 313200109 SOL SPA GR

KALINOX, 50% / 50% medicinsk gas, komprimerad

SE/H/1168/001 23294 AIR LIQUIDE SANTE INTERNATIONAL

SE

Kalinox, medicinsk gas, komprimeret

SE/H/1168/001 49418 AIR LIQUIDE SANTE INTERNATIONAL

DK

Dušični oksidul UTP, najmanje 98,0% V/V, medicinski plin, ukapljen

BE/H/0202/001/MR UP/I-530-09/11-02/342 UTP HR

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290010 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 0392900022 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290034 SOL SPA IT

List of nationally authorised medicinal products EMA/173529/2019 Page 53/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290046 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290059 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290061 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290073 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290085 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290097 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290109 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290111 SOL SPA IT

AZOTO PROTOSSIDO SOL gas medicinale liquefatto

not available 039290123 SOL SPA IT

AZOTO PROTOSSIDO EUROGAS gas medicinale liquefatto

not available 039295035 EUROGAS S.R.L. IT

List of nationally authorised medicinal products EMA/173529/2019 Page 54/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

AZOTO PROTOSSIDO EUROGAS gas medicinale liquefatto

not available 039295023 EUROGAS S.R.L. IT

AZOTO PROTOSSIDO EUROGAS gas medicinale liquefatto

not available 039295011 EUROGAS S.R.L. IT

AZOTO PROTOSSIDO EUROGAS gas medicinale liquefatto

not available 039295047 EUROGAS S.R.L. IT

Protóxido de Azoto Medicinal Gasin, 98 % Gás medicinal liquefeito

not available 5119458 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Protóxido de Azoto Medicinal Gasin, 98 % Gás medicinal liquefeito

not available 5119441 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Protóxido de Azoto Medicinal Gasin, 98 % Gás medicinal liquefeito

not available 5119466 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Actynox 50%/50% v/v medicinaal gas, samengeperst

NL/H/3036/001 BE 463937 AIR PRODUCTS S.A/N.V. BE

Actynox, 50%/50% v/v, medicinaal gas, samengeperst

NL/H/3036/001 RVG 114145 AIR PRODUCTS NEDERLAND B.V.

NL

List of nationally authorised medicinal products EMA/173529/2019 Page 55/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Actynox 50%/50% v/v, Gás medicinal comprimido

NL/H/3036/001 5624218 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Actynox 50%/50% v/v, Gás medicinal comprimido

NL/H/3036/001/DC 5624200 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Actynox 50%/50% v/v, Gás medicinal comprimido

NL/H/3036/001/DC 5624176 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Actynox 50%/50% v/v, Gás medicinal comprimido

NL/H/3036/001/DC 5624168 GASIN II GASES INDUSTRIAIS UNIPESSOAL LDA.

PT

Actynox 50%/50% gas comprimido medicinal

NL/H/3036/001 79717 S.E. CARBUROS METÁLICOS, S.A.

ES

ACTYNOX 50%/50% V/V, GAZ MEDICINAL COMPRIME

NL/H/3036/001 NL 45839 AIR PRODUCTS S.A.S FR

Actynox 50 % / 50 % V/V medicinální plyn, stlačený

NL/H/3036/001 89/1033/16-C AIR PRODUCTS SPOL. S.R.O. CZ

Actynox 50 %/50 % v/v medicinálny plyn stlacený

NL/H/3036/001 05/0234/17-S AIR PRODUCTS SLOVAKIA S R. O.

SK

OxyNox not available PL 06183/0013 AIR PRODUCTS PLC UK

Nodolox 50%/50% gas comprimido medicinal

not available 83099 OXIGEN SALUD S.A. ES

List of nationally authorised medicinal products EMA/173529/2019 Page 56/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PROTÓXIDO DE NITRÓGENO MEDICINAL CARBUROS METÁLICOS, Gas para inhalación, 98,0% v/v, en tanques

not available 67475 S.E. CARBUROS METÁLICOS, S.A.

ES

Latox, medicinsk gas, komprimeret

IS/H/0202/001 49866 STRANDMØLLEN A/S DK

Latox 50% / 50%, lyfjagas, undir þrýstingi

IS/H/0202/001 IS/1/12/092/01 STRANDMØLLEN A/S IS

Latox 50%/ 50%, medicinsk gas, komprimerad

IS/H/0202/001 47188 STRANDMØLLEN A/S SE

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/01 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/02 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/03 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/04 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/05 LINDE GAZ ROMANIA SRL RO

List of nationally authorised medicinal products EMA/173529/2019 Page 57/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/06 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/07 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/08 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/09 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/10 LINDE GAZ ROMANIA SRL RO

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/001 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/002 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/003 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/004 LINDE GAS A.S. SI

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/01 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/02 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

List of nationally authorised medicinal products EMA/173529/2019 Page 58/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/03 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/04 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/05 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/06 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/07 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/08 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/09 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

Dinitrogén-oxid Linde cseppfolyósított Orvosi Gáz

CZ/H/0260/001 OGYI-T-21090/10 LINDE GÁZ MAGYARORSZÁG ZRT.

HU

NIONTIX, medicinální plyn, zkapalněný

CZ/H/0260/001 89/137/08 - C LINDE GAS A.S. CZ

NIONTIX, medicinálny plyn, skvapalnený

CZ/H/0260/001 05/0373/09-S LINDE GAS K.S. SK

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/11 LINDE GAZ ROMANIA SRL RO

List of nationally authorised medicinal products EMA/173529/2019 Page 59/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/12 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/13 LINDE GAZ ROMANIA SRL RO

NIONTIX 100% gaz medicinal lichefiat

CZ/H/0260/001/MR 5660/2013/14 LINDE GAZ ROMANIA SRL RO

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/005 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/006 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/008 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/009 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/010 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/011 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/012 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/013 LINDE GAS A.S. SI

List of nationally authorised medicinal products EMA/173529/2019 Page 60/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/007 LINDE GAS A.S. SI

NIONTIX 100 % medicinski plin, utekočinjeni

CZ/H/0260/001 H/14/01115/014 LINDE GAS A.S. SI

NIONTIX, ιατρικό αέριο, υγροποιημένο

CZ/H/0260/001 33166/31-07-2018 LINDE HELLAS SINGLE PERSON LIMITED LIABILITY COMPANY

GR

OXIDO NITROSO MEDICINAL GAS OXIGEN SALUD, 98,0%, gas licuado medicinal

not available 67000 OXIGEN SALUD S.A. ES

Medical Nitrous Oxide not available PL 15929/0004 AIR LIQUIDE LTD UK

Equanox not available PL 15929/0008 AIR LIQUIDE LTD UK

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292127 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292089 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292115 RIVOIRA S.P.A. IT

List of nationally authorised medicinal products EMA/173529/2019 Page 61/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292103 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292091 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292077 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292065 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292053 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292040 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292038 RIVOIRA S.P.A. IT

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292026 RIVOIRA S.P.A. IT

List of nationally authorised medicinal products EMA/173529/2019 Page 62/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

AZOTO PROTOSSIDO RIVOIRA PHARMA GAS MEDICINALE LIQUEFATTO

not available 039292014 RIVOIRA S.P.A. IT

NIONTIX®|100 %|Gas zur medizinischen Anwendung, verflüssigt

not available 1807.00.00 LINDE GAS THERAPEUTICS GMBH

DE

Distickstoffmonoxid für medizinische Zwecke

not available 2349.99.99-5049896 PRAXAIR DEUTSCHLAND GMBH DE

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291024 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291125 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291113 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291101 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291099 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

List of nationally authorised medicinal products EMA/173529/2019 Page 63/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291087 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291075 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291063 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291051 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291048 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291036 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO SIAD gas medicinale liquefatto

not available 039291012 SOCIETA' ITALIANA ACETILENE E DERIVATI S.I.A.D. S.P.A.

IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299019 MEDICAIR ITALIA S.R.L. IT

List of nationally authorised medicinal products EMA/173529/2019 Page 64/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299021 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299033 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299045 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299058 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299060 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299072 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299084 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299096 MEDICAIR ITALIA S.R.L. IT

List of nationally authorised medicinal products EMA/173529/2019 Page 65/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299108 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299110 MEDICAIR ITALIA S.R.L. IT

AZOTO PROTOSSIDO MEDICAIR gas medicinale liquefatto

not available 039299122 MEDICAIR ITALIA S.R.L. IT

Ιατρικό πρωτοξείδιο του αζώτου, Linde- Hadjikyriakos Gas Ltd αέριο εισπνοής.

not available 20297 LINDE HADJIKYRIAKOS GAS LTD

CY

ÓXIDO NITROSO MEDICINAL LINDE, 98,0% gas licuado medicinal

not available 67444 ABELLO LINDE, S.A. ES

Stickoxydul medizinisch Air Liquide

not available 1-26087 AIR LIQUIDE AUSTRIA GMBH AT

KALINOX 50%/50% gaz médicinal, comprimé

FR/H/0409/001 34009 396 422 4 6 AIR LIQUIDE SANTE INTERNATIONAL

FR

KALINOX 50%/50% gaz médicinal, comprimé

FR/H/0409/001 34009 562 162 3 9 AIR LIQUIDE SANTE INTERNATIONAL

FR

List of nationally authorised medicinal products EMA/173529/2019 Page 66/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

KALINOX 50%/50% gaz médicinal, comprimé

FR/H/0409/001 34009 396 423 0 7 AIR LIQUIDE SANTE INTERNATIONAL

FR

KALINOX 50%/50% gaz médicinal, comprimé

FR/H/0409/001 34009 218 408 5 8 AIR LIQUIDE SANTE INTERNATIONAL

FR

KALINOX 50%/50% gaz médicinal, comprimé

FR/H/0409/001 34009 564 525 6 9 AIR LIQUIDE SANTE INTERNATIONAL

FR

KALINOX 50%/50% gaz médicinal, comprimé

FR/H/0409/001 34009 562 164 6 8 AIR LIQUIDE SANTE INTERNATIONAL

FR

KALINOX, 50% + 50%, gaz medyczny sprezony

FR/H/0409/001 18546 AIR LIQUIDE SANTE INTERNATIONAL

PL

KALINOX, 50%/50% gas medicinale, compresso

FR/H/0409/001 040914018 AIR LIQUIDE SANTE INTERNATIONAL

IT

KALINOX, 50%/50% gas medicinale, compresso

FR/H/0409/001 040914020 AIR LIQUIDE SANTE INTERNATIONAL

IT

KALINOX, 50%/50% gas medicinale, compresso

FR/H/0409/001 040914044 AIR LIQUIDE SANTE INTERNATIONAL

IT

KALINOX, 50%/50% gas medicinale, compresso

FR/H/0409/001 040914057 AIR LIQUIDE SANTE INTERNATIONAL

IT

KALINOX, 50%/50% gas medicinale, compresso

FR/H/0409/001 040914032 AIR LIQUIDE SANTE INTERNATIONAL

IT

List of nationally authorised medicinal products EMA/173529/2019 Page 67/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

KALINOX 50 %/ 50 % Gas zur medizinischen Anwendung, druckverdichtet

FR/H/0409/001 1-30414 AIR LIQUIDE SANTE INTERNATIONAL

AT

Kalinox 50%/50%, gás medicinal comprimido

FR/H/0409/001 5375753 AIR LIQUIDE SANTE INTERNATIONAL

PT

Kalinox 50%/50%, gás medicinal comprimido

FR/H/0409/001 5375746 AIR LIQUIDE SANTE INTERNATIONAL

PT

KALINOX 170 BAR 50%/50% (v/v), medicinaal gas, samengeperst

not available RVG 30361 AIR LIQUIDE SANTE INTERNATIONAL

NL

Medizinisches Distikstoffoxid Air Liquide Santé International 100 %, Gas zur medizinischen Anwendung, verflüssigt

not available BE 180126 AIR LIQUIDE SANTE INTERNATIONAL

BE

Medizinisches Distikstoffoxid Air Liquide Santé International 100 %, Gas zur medizinischen Anwendung, verflüssigt

not available BE 180144 AIR LIQUIDE SANTE INTERNATIONAL

BE

List of nationally authorised medicinal products EMA/173529/2019 Page 68/73

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Protoxyde d'azote Médical, Air Liquide Santé International 100 %, gaz médicinal liquéfié

not available BE 180126 AIR LIQUIDE SANTE INTERNATIONAL

BE

Medisch Distikstofoxide, Air Liquide Santé International 100 %, Medicinaal gas, vloeibaar gemaakt

not available BE 180126 AIR LIQUIDE SANTE INTERNATIONAL

BE

Protoxyde d'azote Médical, Air Liquide Santé International 100 %, gaz médicinal liquéfié

not available BE 180144 AIR LIQUIDE SANTE INTERNATIONAL

BE

Medisch Distikstofoxide, Air Liquide Santé International 100 %, Medicinaal gas, vloeibaar gemaakt

not available BE 180144 AIR LIQUIDE SANTE INTERNATIONAL

BE

Distikstofoxide medicinaal Air Liquide, medicinaal gas, vloeibaar gemaakt 100% v/v

not available RVG 30359 AIR LIQUIDE SANTE INTERNATIONAL

NL

Pro