This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
List of nationally authorised medicinal products EMA/716513/2017 Page 10/32
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
Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/085 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/101 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/098 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/100 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/087 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/079 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/089 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/096 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/090 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/088 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/094 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/078 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/080 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/077 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/072 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg trde kapsule DE/H/3456/003 H/93/00473/073 PFIZER LUXEMBOURG SARL SI Diflucan 150 mg tvrdé kapsuly DE/H/3456/003 26/0111/12–S PFIZER EUROPE MA EEIG SK Diflucan 150 mg Tvrdé tobolky DE/H/3456/003 26/121/91 – C/C PFIZER, SPOL. S R.O. CZ Diflucan 150 mg, capsule, hard DE/H/3456/003 RVG 13039 PFIZER B.V. NL Diflucan 150 mg, kõvakapslid DE/H/3456/003 104595 PFIZER EUROPE MA EEIG EE Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 BE305426 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 BE155854 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 BE444026 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 BE444035 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 BE192945 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 BE305417 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU
List of nationally authorised medicinal products EMA/716513/2017 Page 11/32
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
Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU Diflucan 2 mg/ml Infusionslösung Fluconazol DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU Diflucan 2 mg/ml infusionsvätska, lösning DE/H/3456/006 10021 PFIZER OY FI Diflucan 2 mg/ml infusionsvätska, lösning DE/H/3456/006 10021 PFIZER OY FI Diflucan 2 mg/ml infusionsvätska, lösning DE/H/3456/006 10021 PFIZER OY FI Diflucan 2 mg/ml infusionsvätska, lösning DE/H/3456/006 10021 PFIZER OY FI Diflucan 2 mg/ml infusionsvätska, lösning DE/H/3456/006 11153 PFIZER AB SE Diflucan 2 mg/ml infusjonsvæske, oppløsning DE/H/3456/006 7597 PFIZER AS NO Diflucan 2 mg/ml infusjonsvæske, oppløsning DE/H/3456/006 7597 PFIZER AS NO Diflucan 2 mg/ml infusjonsvæske, oppløsning DE/H/3456/006 7597 PFIZER AS NO Diflucan 2 mg/ml infusjonsvæske, oppløsning DE/H/3456/006 7597 PFIZER AS NO Diflucan 2 mg/ml infuusioneste, liuos DE/H/3456/006 10021 PFIZER OY FI Diflucan 2 mg/ml infuusioneste, liuos DE/H/3456/006 10021 PFIZER OY FI Diflucan 2 mg/ml infuusioneste, liuos DE/H/3456/006 10021 PFIZER OY FI Diflucan 2 mg/ml infuusioneste, liuos DE/H/3456/006 10021 PFIZER OY FI Diflucan 2 mg/ml innrennslislyf, lausn DE/H/3456/006 890097 PFIZER APS IS Diflucan 2 mg/ml innrennslislyf, lausn DE/H/3456/006 890097 PFIZER APS IS Diflucan 2 mg/ml innrennslislyf, lausn DE/H/3456/006 890097 PFIZER APS IS Diflucan 2 mg/ml innrennslislyf, DE/H/3456/006 890097 PFIZER APS IS
List of nationally authorised medicinal products EMA/716513/2017 Page 12/32
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
lausn Diflucan 2 mg/ml oldatos infúzió DE/H/3456/006 OGYI-T-1550/09 PFIZER KFT. HU Diflucan 2 mg/ml oldatos infúzió DE/H/3456/006 OGYI-T-1550/09 PFIZER KFT. HU Diflucan 2 mg/ml oldatos infúzió DE/H/3456/006 OGYI-T-1550/09 PFIZER KFT. HU Diflucan 2 mg/ml oldatos infúzió DE/H/3456/006 OGYI-T-1550/09 PFIZER KFT. HU Diflucan 2 mg/ml oplossing voor infusie DE/H/3456/006 BE305426 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml oplossing voor infusie DE/H/3456/006 BE444026 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml oplossing voor infusie DE/H/3456/006 BE155854 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml oplossing voor infusie DE/H/3456/006 BE444035 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml oplossing voor infusie DE/H/3456/006 BE192945 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml oplossing voor infusie DE/H/3456/006 BE305417 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml otopina za infuziju not available UP/I-530-09/11-02/633 PFIZER CROATIA D.O.O. HR Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/127 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/123 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/119 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/120 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/128 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/117 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/124 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/716513/2017 Page 13/32
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
Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/121 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/125 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/122 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/118 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml raztopina za infundiranje DE/H/3456/006 H/93/00473/126 PFIZER LUXEMBOURG SARL SI Diflucan 2 mg/ml šķīdums infūzijām DE/H/3456/006 96-0660 PFIZER LIMITED LV Diflucan 2 mg/ml šķīdums infūzijām DE/H/3456/006 96-0660 PFIZER LIMITED LV Diflucan 2 mg/ml šķīdums infūzijām DE/H/3456/006 96-0660 PFIZER LIMITED LV Diflucan 2 mg/ml šķīdums infūzijām DE/H/3456/006 96-0660 PFIZER LIMITED LV Diflucan 2 mg/ml solução para perfusão DE/H/3456/006 DE/H/3456/06/MR LABORATÓRIOS PFIZER, LDA. PT Diflucan 2 mg/ml solução para perfusão DE/H/3456/006 DE/H/3456/06/MR LABORATÓRIOS PFIZER, LDA. PT Diflucan 2 mg/ml solução para perfusão DE/H/3456/006 8741702 LABORATÓRIOS PFIZER, LDA. PT Diflucan 2 mg/ml solução para perfusão DE/H/3456/006 8741710 LABORATÓRIOS PFIZER, LDA. PT Diflucan 2 mg/ml solución para perfusión DE/H/3456/006 58.817 VINCIFARMA S.A. ES Diflucan 2 mg/ml solución para perfusión DE/H/3456/006 58.817 VINCIFARMA S.A. ES Diflucan 2 mg/ml solución para perfusión DE/H/3456/006 58.817 VINCIFARMA S.A. ES Diflucan 2 mg/ml solución para perfusión DE/H/3456/006 58.817 VINCIFARMA S.A. ES Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/09 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie DE/H/3456/006 6166/2014/07 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/716513/2017 Page 14/32
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
perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/01 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/06 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/02 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/08 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/03 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/04 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/05 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/10 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/12 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml soluţie perfuzabilă DE/H/3456/006 6166/2014/11 PFIZER EUROPE MA EEIG RO Diflucan 2 mg/ml solution for infusion DE/H/3456/006 PA 19/44/8 PFIZER LIMITED IE Diflucan 2 mg/ml solution for infusion DE/H/3456/006 PA 19/044/012 PFIZER LIMITED IE Diflucan 2 mg/ml solution for infusion DE/H/3456/006 PL 00057/0315 PFIZER LIMITED UK Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 BE444026 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 BE192945 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 BE155854 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 BE305417 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 BE305426 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/716513/2017 Page 15/32
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
Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 BE444035 PFIZER S.A. (BELGIUM) BE Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU Diflucan 2 mg/ml solution pour perfusion DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 027267032 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 027267071 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 027267083 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489172 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489133 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489158 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489184 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489160 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489145 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489119 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489121 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489196 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per infusione DE/H/3456/006 043489210 PFIZER ITALIA S.R.L. IT Diflucan 2 mg/ml soluzione per DE/H/3456/006 027267107 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/716513/2017 Page 16/32
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
infusione Diflucan 2 mg/ml, infusioonilahus DE/H/3456/006 109995 PFIZER EUROPE MA EEIG EE Diflucan 2 mg/ml, infusioonilahus DE/H/3456/006 109995 PFIZER EUROPE MA EEIG EE Diflucan 2 mg/ml, infusioonilahus DE/H/3456/006 109995 PFIZER EUROPE MA EEIG EE Diflucan 2 mg/ml, infusioonilahus DE/H/3456/006 109995 PFIZER EUROPE MA EEIG EE Diflucan 200 mg cápsulas DE/H/3456/004 4571980 LABORATÓRIOS PFIZER, LDA. PT Diflucan 200 mg cápsulas DE/H/3456/004 2074680 LABORATÓRIOS PFIZER, LDA. PT Diflucan 200 mg cápsulas duras DE/H/3456/004 58.803 VINCIFARMA S.A. ES Diflucan 200 mg capsule rigide DE/H/3456/004 027267095 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489069 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489071 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489057 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489018 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 027267982 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 027267970 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 027267968 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489020 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 027267943 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489032 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489044 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 027267994 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 027267956 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489107 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489083 PFIZER ITALIA S.R.L. IT Diflucan 200 mg capsule rigide DE/H/3456/004 043489095 PFIZER ITALIA S.R.L. IT Diflucan 200 mg gélules DE/H/3456/004 BE253513 PFIZER S.A. (BELGIUM) BE Diflucan 200 mg gélules DE/H/3456/006 2003097826 PFIZER S.A. (BELGIUM) LU Diflucan 200 mg hard capsules DE/H/3456/004 PA 19/44/04 PFIZER LIMITED IE Diflucan 200 mg hard capsules DE/H/3456/004 PL 00057/0317 PFIZER LIMITED UK Diflucan 200 mg hårda kapslar DE/H/3456/004 11156 PFIZER AB SE Diflucan 200 mg harde capsules DE/H/3456/004 BE253513 PFIZER S.A. (BELGIUM) BE Diflucan 200 mg Hartkapseln DE/H/3456/004 BE253513 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/716513/2017 Page 17/32
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
Fluconazol Diflucan 200 mg Hartkapseln Fluconazol DE/H/3456/006 2003097826 PFIZER S.A. (BELGIUM) LU Diflucan 200 mg kapsel, hard DE/H/3456/004 7601 PFIZER AS NO Diflucan 200 mg kemény kapszula DE/H/3456/004 OGYI-T-1550/06 PFIZER KFT. HU Diflucan 200 mg, capsule, hard DE/H/3456/004 RVG 14768 PFIZER B.V. NL Diflucan 40 mg/ml jauhe oraalisuspensiota varten DE/H/3456/008 11543 PFIZER OY FI Diflucan 40 mg/ml pó para suspensão oral DE/H/3456/008 2132280 LABORATÓRIOS PFIZER, LDA. PT Diflucan 40 mg/ml poeder voor orale suspensie DE/H/3456/008 BE160413 PFIZER S.A. (BELGIUM) BE Diflucan 40 mg/ml polvo para suspensión oral DE/H/3456/008 59.673 VINCIFARMA S.A. ES Diflucan 40 mg/ml por belsőleges szuszpenzióhoz DE/H/3456/008 OGYI-T-1550/08 PFIZER KFT. HU Diflucan 40 mg/ml poudre pour suspension buvable DE/H/3456/008 BE160413 PFIZER S.A. (BELGIUM) BE Diflucan 40 mg/ml poudre pour suspension buvable DE/H/3456/008 2003097828 PFIZER S.A. (BELGIUM) LU Diflucan 40 mg/ml powder for oral suspension DE/H/3456/008 PA 19/44/11 PFIZER LIMITED IE Diflucan 40 mg/ml powder for oral suspension DE/H/3456/008 PL 00057/0344 PFIZER LIMITED UK Diflucan 40 mg/ml prašek za peroralno suspenzijo DE/H/3456/008 H/93/00473/111 PFIZER LUXEMBOURG SARL SI Diflucan 40 mg/ml prašek za peroralno suspenzijo DE/H/3456/008 H/93/00473/114 PFIZER LUXEMBOURG SARL SI Diflucan 40 mg/ml prašek za peroralno suspenzijo DE/H/3456/008 H/93/00473/113 PFIZER LUXEMBOURG SARL SI Diflucan 40 mg/ml prašek za peroralno suspenzijo DE/H/3456/008 H/93/00473/112 PFIZER LUXEMBOURG SARL SI Diflucan 40 mg/ml prašek za peroralno suspenzijo DE/H/3456/008 H/93/00473/115 PFIZER LUXEMBOURG SARL SI Diflucan 40 mg/ml prašek za peroralno suspenzijo DE/H/3456/008 H/93/00473/116 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/716513/2017 Page 18/32
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
Diflucan 40 mg/ml pulver til mikstur, suspensjon DE/H/3456/008 00/7659 PFIZER AS NO Diflucan 40 mg/ml pulver till oral suspension DE/H/3456/008 11543 PFIZER OY FI Diflucan 40 mg/ml pulver till oral suspension DE/H/3456/008 11345 PFIZER AB SE Diflucan 40 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen Fluconazol DE/H/3456/008 BE160413 PFIZER S.A. (BELGIUM) BE Diflucan 40 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen Fluconazol DE/H/3456/008 2003097828 PFIZER S.A. (BELGIUM) LU Diflucan 40 mg/ml, poeder voor orale suspensie DE/H/3456/008 RVG 15758 PFIZER B.V. NL Diflucan 50 mg cápsulas DE/H/3456/001 8692806 LABORATÓRIOS PFIZER, LDA. PT Diflucan 50 mg cápsulas duras DE/H/3456/001 58.765 VINCIFARMA S.A. ES Diflucan 50 mg capsule DE/H/3456/001 5124/2012/01 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/02 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/14 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/05 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/10 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/08 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/13 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/07 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/06 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/09 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/12 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/04 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/03 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/11 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/15 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/19 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/18 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/16 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/17 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/23 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/716513/2017 Page 19/32
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
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/25 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/31 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/21 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/27 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/33 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/29 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/24 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/34 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/20 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/30 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/28 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/22 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/26 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule DE/H/3456/001 5124/2012/32 PFIZER EUROPE MA EEIG RO Diflucan 50 mg capsule rigide DE/H/3456/001 027267018 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267448 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267297 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267436 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267412 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267158 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267121 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267273 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267145 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267398 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267386 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267285 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267259 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267400 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267133 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267374 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267261 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267234 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267246 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267347 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267362 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267350 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/716513/2017 Page 20/32
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
Diflucan 50 mg capsule rigide DE/H/3456/001 027267208 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267210 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267222 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267160 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267335 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267172 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267184 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267311 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267309 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267196 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267323 PFIZER ITALIA S.R.L. IT Diflucan 50 mg capsule rigide DE/H/3456/001 027267424 PFIZER ITALIA S.R.L. IT Diflucan 50 mg gélules DE/H/3456/001 BE253486 PFIZER S.A. (BELGIUM) BE Diflucan 50 mg gélules DE/H/3456/001 2003097823 PFIZER S.A. (BELGIUM) LU Diflucan 50 mg hard capsules DE/H/3456/001 PA 19/44/1 PFIZER LIMITED IE Diflucan 50 mg hard capsules DE/H/3456/001 PL 00057/0289 PFIZER LIMITED UK Diflucan 50 mg hårda kapslar DE/H/3456/001 10044 PFIZER OY FI Diflucan 50 mg hårda kapslar DE/H/3456/001 11154 PFIZER AB SE Diflucan 50 mg harde capsules DE/H/3456/001 BE253486 PFIZER S.A. (BELGIUM) BE Diflucan 50 mg Hartkapseln Fluconazol DE/H/3456/001 BE253486 PFIZER S.A. (BELGIUM) BE Diflucan 50 mg Hartkapseln Fluconazol DE/H/3456/001 2003097823 PFIZER S.A. (BELGIUM) LU Diflucan 50 mg kapsel, hard DE/H/3456/001 7598 PFIZER AS NO Diflucan 50 mg kapsule not available UP/I-530-09/11-02/629 PFIZER CROATIA D.O.O. HR Diflucan 50 mg kemény kapszula DE/H/3456/001 OGYI-T-1550/01 PFIZER KFT. HU DIFLUCAN 50 mg kietosios kapsulės DE/H/3456/001 LT/1/96/1923/014 PFIZER LIMITED LT DIFLUCAN 50 mg kietosios kapsulės DE/H/3456/001 LT/1/96/1923/017 PFIZER LIMITED LT DIFLUCAN 50 mg kietosios kapsulės DE/H/3456/001 LT/1/96/1923/018 PFIZER LIMITED LT DIFLUCAN 50 mg kietosios kapsulės DE/H/3456/001 LT/1/96/1923/016 PFIZER LIMITED LT DIFLUCAN 50 mg kietosios DE/H/3456/001 LT/1/96/1923/001 PFIZER LIMITED LT
List of nationally authorised medicinal products EMA/716513/2017 Page 21/32
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Fluconazol Aurobindo 150 mg Hartkapseln UK/H/1265/003 72224.00.00 AUROBINDO PHARMA GMBH DE Fluconazol B. Braun 2 mg/ml Infusionslösung DE/H/1055/001 1-28430 B. BRAUN MELSUNGEN AG ART 57 AT Fluconazol B. Braun 2 mg/ml Infusionslösung DE/H/1055/001 69716.00.00 B.BRAUN MELSUNGEN AG DE Fluconazol B. Braun 2 mg/ml Infusionslösung DE/H/1055/001 0667/08120050 B.BRAUN MELSUNGEN AG LU Fluconazol B. Braun 2 mg/ml infusjonsvæske, oppløsning DE/H/1055/001 07-5146 B.BRAUN MELSUNGEN AG NO Fluconazol B. Braun 2 mg/ml solución para perfusión EFG DE/H/1055/001 71461 B.BRAUN MELSUNGEN AG ES Fluconazol B. Braun 2 mg/ml, oplossing voor infusie DE/H/1055/001 RVG 100710 B.BRAUN MELSUNGEN AG NL Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178314 B.BRAUN MELSUNGEN AG PT Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178330 B.BRAUN MELSUNGEN AG PT Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178322 B.BRAUN MELSUNGEN AG PT
List of nationally authorised medicinal products EMA/716513/2017 Page 27/32
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
Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178355 B.BRAUN MELSUNGEN AG PT Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178348 B.BRAUN MELSUNGEN AG PT Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178363 B.BRAUN MELSUNGEN AG PT Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178405 B.BRAUN MELSUNGEN AG PT Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178371 B.BRAUN MELSUNGEN AG PT Fluconazol B. Braun, 2 mg/ml, solução para perfusão DE/H/1055/001 5178306 B.BRAUN MELSUNGEN AG PT FLUCONAZOL LPH 150 mg capsule not available 3659/2011/01 LABORMED PHARMA S.A. RO FLUCONAZOL LPH 50 mg capsule not available 3658/2011/01 LABORMED PHARMA S.A. RO Fluconazol Pfizer 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen DE/H/3457/005 89509.00.00 PFIZER PHARMA PFE GMBH DE Fluconazol Pfizer 150 mg Hartkapseln DE/H/3457/006 90450.00.00 PFIZER PHARMA PFE GMBH DE Fluconazol Pfizer® 100 mg Hartkapseln DE/H/3457/003 89510.00.00 PFIZER PHARMA PFE GMBH DE Fluconazol Pfizer® 200 mg Hartkapseln DE/H/3457/004 89511.00.00 PFIZER PHARMA PFE GMBH DE
Fluconazole 100 mg Capsules not available PL 36722/0121 SPECIAL CONCEPT DEVELOPMENT (UK) LTD UK
Fluconazole 100 mg capsules, hard UK/H/1265/002 PL 16363/0316 MILPHARM LIMITED UK Fluconazole 100 mg καψάκια, σκληρά UK/H/1265/002 79974
AUROBINDO PHARMA (MALTA) LIMITED GR
Fluconazole 150 mg Capsules not available PL 36722/0122 SPECIAL CONCEPT DEVELOPMENT (UK) LTD UK
Fluconazole 150mg Capsules not available PL 21880/0135 MEDREICH PLC UK Fluconazole 150mg Capsules not available PL 20395/0042 RELON CHEM LIMITED UK Fluconazole 150mg Capsules not available PL 20395/0041 RELON CHEM LIMITED UK Fluconazole 2 mg/ml solution DE/H/1055/001 PA 736/30/1 B.BRAUN MELSUNGEN AG IE
List of nationally authorised medicinal products EMA/716513/2017 Page 28/32
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
for infusion Fluconazole 2 mg/ml solution for infusion DE/H/1055/001 PL 03551/0115 B.BRAUN MELSUNGEN AG UK
Fluconazole 200 mg Capsules not available PL 36722/0123 SPECIAL CONCEPT DEVELOPMENT (UK) LTD UK
Fluconazole 200mg Capsules not available PL 21880/0136 MEDREICH PLC UK
Fluconazole 50 mg Capsules not available PL 36722/0120 SPECIAL CONCEPT DEVELOPMENT (UK) LTD UK
Fluconazole 50mg Capsules not available PL 21880/0134 MEDREICH PLC UK Fluconazole B. Braun 2 mg/ml infusionsvätska, lösning DE/H/1055/001 25835 B.BRAUN MELSUNGEN AG SE Fluconazole B. Braun 2 mg/ml infuusioneste, liuos DE/H/1055/001 23931 B.BRAUN MELSUNGEN AG FI Fluconazole B. Braun 2 mg/ml infuzní roztok DE/H/1055/001 26/048/09-C B.BRAUN MELSUNGEN AG CZ Fluconazole B. Braun 2 mg/ml infúzny roztok DE/H/1055/001 26/0074/09-S B.BRAUN MELSUNGEN AG SK Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/04 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/05 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/06 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/07 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/08 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/09 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/01 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/02 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml oldatos infúzió DE/H/1055/001 OGYI-T-21734/03 B.BRAUN MELSUNGEN AG HU Fluconazole B. Braun 2 mg/ml solution pour perfusion DE/H/1055/001 BE334014 B.BRAUN MELSUNGEN AG BE
List of nationally authorised medicinal products EMA/716513/2017 Page 29/32
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
Fluconazole B. Braun 2 mg/ml solution pour perfusion DE/H/1055/001 BE334065 B.BRAUN MELSUNGEN AG BE Fluconazole B. Braun 2 mg/ml solution pour perfusion DE/H/1055/001 BE334083 B.BRAUN MELSUNGEN AG BE Fluconazole B. Braun 2 mg/ml διάλυμα προς έγχυση DE/H/1055/001 64925/14-09-2009 B.BRAUN MELSUNGEN AG GR Fluconazole B. Braun 2 mg/ml, oplossing voor infusie DE/H/1055/001 BE334014 B.BRAUN MELSUNGEN AG BE Fluconazole B. Braun 2 mg/ml, oplossing voor infusie DE/H/1055/001 BE334065 B.BRAUN MELSUNGEN AG BE Fluconazole B. Braun 2 mg/ml, oplossing voor infusie DE/H/1055/001 BE334083 B.BRAUN MELSUNGEN AG BE Fluconazole B. Braun 2 mg/ml, roztwór do infuzji DE/H/1055/001 15636 B.BRAUN MELSUNGEN AG PL FLUCONAZOLE PFIZER 100 mg, gélule DE/H/3457/003 34009 346 591 7 1 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 100 mg, gélule DE/H/3457/003 34009 338 672 1 8 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 150 mg, gélule DE/H/3456/003 34009 330 553 3 2 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 200 mg, gélule DE/H/3457/004 34009 346 590 0 3 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 200 mg, gélule DE/H/3457/004 34009 338 677 3 7 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 50 mg, gélule DE/H/3457/001 34009 338 679 6 6 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 50 mg, gélule DE/H/3457/001 34009 558 948 6 5 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 50 mg, gélule DE/H/3457/001 34009 338 680 4 8 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 50 mg/5 ml, poudre pour suspension buvable DE/H/3457/005 34009 338 682 7 7 PFIZER HOLDING FRANCE FR FLUCONAZOLE PFIZER 50 mg/5 ml, poudre pour suspension buvable DE/H/3457/005 34009 338 682 7 7 PFIZER HOLDING FRANCE FR Fluconazolo B. Braun 2 mg/ml DE/H/1055/001 038838025 B.BRAUN MELSUNGEN AG IT
List of nationally authorised medicinal products EMA/716513/2017 Page 30/32
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
soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione DE/H/1055/001 038838037 B.BRAUN MELSUNGEN AG IT Fluconazolo B. Braun 2 mg/ml soluzione per infusione DE/H/1055/001 038838049 B.BRAUN MELSUNGEN AG IT Fluconazolo B. Braun 2 mg/ml soluzione per infusione DE/H/1055/001 038838052 B.BRAUN MELSUNGEN AG IT Fluconazolo B. Braun 2 mg/ml soluzione per infusione DE/H/1055/001 038838064 B.BRAUN MELSUNGEN AG IT Fluconazolo B. Braun 2 mg/ml soluzione per infusione DE/H/1055/001 038838076 B.BRAUN MELSUNGEN AG IT Fluconazolo B. Braun 2 mg/ml soluzione per infusione DE/H/1055/001 038838088 B.BRAUN MELSUNGEN AG IT Fluconazolo B. Braun 2 mg/ml soluzione per infusione DE/H/1055/001 038838090 B.BRAUN MELSUNGEN AG IT Fluconazolo B. Braun 2 mg/ml soluzione per infusione DE/H/1055/001 038838013 B.BRAUN MELSUNGEN AG IT Flukonazol B. Braun 2 mg/ml raztopina za infundiranje DE/H/1055/001 H/09/00634/003 B.BRAUN MELSUNGEN AG SI Flukonazol B. Braun 2 mg/ml raztopina za infundiranje DE/H/1055/001 H/09/00634/002 B.BRAUN MELSUNGEN AG SI Flukonazol B. Braun 2 mg/ml raztopina za infundiranje DE/H/1055/001 H/09/00634/001 B.BRAUN MELSUNGEN AG SI Fungata® DE/H/3456/003 15824.00.00 PFIZER PHARMA PFE GMBH DE
Fungata® 150 mg – Kapsel DE/H/3457/006 1-18837 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT