Page 1
SPECIAL ISSUE
THE KENYA GAZETTE Published by Authority of the Republic of Kenya
(Registered as a Newspaper at the G.P.O.)
Vol. CXIII—No. 75 NAIROBI, 3rd August, 2011 Price Sh. 50
GAZETTE NOTICE NO. 9237
THE PHARMACY AND POISONS ACT
(Cap. 244)
THE PHARMACY AND POISONS BOARD
PRODUCT EVALUATION AND REGISTRATION DIRECTORATE
PRODUCTS REGISTERED FROM JULY TO DECEMBER, 2010
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
21645 H2010/21645/454 Esoflux 20mg Capsules Esomeprazole 20mg Acme Laboratories 25th Aug 2010
21644 H2010/21644/455 Esoflux 40mg Capsules Esomeprazole 40mg Acme Laboratories 25th Aug 2010
21646 H2010/21646/456 Hemoproct Suppositories Cinchocaine Hcl Bp 5mg;
Hydrocortisone Hcl Bp 5mg; Framycetin Sulphate Bp 10mg;
Aesculin 10mg
Acme Laboratories 25th Aug 2010
21682 H2010/21682/457 Monas 10 Tablets Montelukast Sodium Inn 10.4mg
Equivalent To Montelukast 10mg Acme Laboratories 25th Aug 2010
21680 H2010/21680/458 Nidox Powder Suspension Nitazoxamide 100mg/5mg Acme Laboratories 25th Aug 2010
21647 H2010/21647/459 Nidozox 500mg Tablets Nitazoxanide Inn 500mg Acme Laboratories 25th Aug 2010
19671 H2010/19671/460 Nurifer Capsules Carbonyl Iron Equivalent To Iron
100mg; Folic Acid Bp 1.5mg; Cynocobalamine Bp 15mcg; Ascorbic
Acid Bp 75mg; Zinc Sulfate Monohydrate Usp 61.8mg
Ajanta Pharma Ltd 25th Aug 2010
21170 H2010/21170/461 Airtical-E Tablets Glucosamine Hcl 647.135mg;
Chondroitin Sulphate Sodium
541.565mg
Amol Pharmaceuticals
Ltd 25th Aug 2010
21169 H2010/21169/462 Amlodip 5mg Tablets Amlodipine Besilate Equivalent To
Amlodipine 5mg
Amol Pharmaceuticals
Ltd 25th Aug 2010
19621 H2010/19621/463 Amrizole Suspension Benzoyl Metronidazole 200mg
Equivalent To Metronidazole 125mg
Amriya
Pharmaceuticals 25th Aug 2010
19620 H2010/19620/464 Ketofan Gel Ketoprofen 2.5gm Amriya
Pharmaceuticals 25th Aug 2010
22248 H2010/22248/465 Met-C Gel Metronidazole Bp 1.00% W/W; Chlorhexidine Gluconate Solution Bp Equivalent To Chlorhexidine
Gluconate 0.25% W/W
Stedman Pharmaceuticals For Armicon
Pharmaceuticals Limited
25th Aug 2010
[2953
Page 2
THE KENYA GAZETTE 3rd August, 2011
2954
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
21827 H2010/21827/466 Asmol Tablets Paracetamol B.P 500mg Astra Lifecare 25th Aug 2010
20450 H2010/20450/467 Water For
Injection Solution Water For Injection Bp B. Braun Melsungen
Ag; Germany For Autosterile Ltd;
Kenya
25th Aug 2010
20686 H2010/20686/468 Histargan 25mg Tablets Promethazine Hcl 25mg Biodeal Laboratories 25th Aug 2010
21003 H2010/21003/469 Azidoc 500mg Tablets Azithromycin Usp 500mg As
Azithromycin Dehydrate
Biodeal Laboratories
Pvt Ltd For Doctor Pharma Uk
25th Aug 2010
22051 H2010/22051/470 Bg-Zole 400 Tablets Albendazole Bp 400mg Bliss Gvs Pharma 25th Aug 2010
20933 H2010/20933/471 Kefrox 125mg/5ml Suspension Cefuroxime Axetil Bp Equivalent To Cefuroxime 250mg
Ccl Pharmaceuticals (Pvt) Ltd; Pakistan
25th Aug 2010
21906 H2010/21906/472 Alerset Tablets Betamethasone Bp 0.25mg;
Dexchlorpheniramine Maleate Bp 2mg
Centaur
Pharmaceuticals Pvt
Ltd For Sai Pharmaceuticals
25th Aug 2010
21902 H2010/21902/473 Lamivudine/Nevir
apine/Zidovudine Tablets Lamivudine 150mg; Neviralpine
200mg; Zidovudine 300mg
Centaur
Pharmaceuticals Pvt Ltd
25th Aug 2010
21429 H2010/21429/474 Amlocip-Nb Tablets Amlodipine 5mg; Nebivolol 5mg Cipla Ltd 25th Aug 2010
16640 H2010/16640/475 Duovir-N Tablets Zidovudine Usp 300mg; Lamivudine Usp 101mg; Nevirapine Usp 200mg
Cipla Ltd 25th Aug 2010
19043 H2010/19043/476 Isotroin-10 Capsules Isotretinoin Usp 10mg Cipla Ltd 25th Aug 2010
19042 H2010/19042/477 Isotroin-20 Capsules Isotretinoin Usp 20mg Cipla Ltd 25th Aug 2010
21432 H2010/21432/478 Lansec Dt Junior Tablets Lansoprazole 15mg Cipla Ltd 25th Aug 2010
21360 H2010/21360/479 Profenac 50mg Tablets Diclofenac Sodium 50mg Cipla Ltd 25th Aug 2010
19916 H2010/19916/480 Curaxone 1g Injection Ceftriaxone Sodium Usp 1gm Claris Lifesciences
Limited 25th Aug 2010
20164 H2010/20164/481 Flucanol Injection Fluconale 200mg Claris Lifesciences
Limited 25th Aug 2010
21797 H2010/21797/482 Microlyse
Disinfectant Solution Benzalkonium Chloride Solution Ip
4% Coral Clinical Systems 25th Aug 2010
21755 H2010/21755/483 Daclobet 15g Cream Clobetasol Propionate Bp 0.05% W/W Dawa Limited 25th Aug 2010
19532 H2010/19532/484 Azo Powder Powder For
Suspension Azithromycin 200mg Delta Pharma Limited 25th Aug 2010
10609 H2010/10609/485 Elymox-500 Capsules Amoxycillin (As Trihydrate) 500mg Elys Chemical Industries Ltd
25th Aug 2010
21311 H2010/21311/486 Etorix 60mg Tablets Etoricoxib 60mg Eskayef Bangladesh 25th Aug 2010
21310 H2010/21310/487 Etorix 90mg Tablets Etoricoxib 90mg Eskayef Bangladesh 25th Aug 2010
21309 H2010/21309/488 Noglog 75mg Tablets Clopidogrel 75mg Eskayef Bangladesh 25th Aug 2010
21943 H2010/21943/489 Julee Hormonal
Contraceptive Tablets Desogestrel Bp 0.15; Ethinyl Estradiol
Usp 0.03mg Famy Care Ltd 25th Aug 2010
21590 H2010/21590/490 Nucleo C.M.P
Forte Capsules Citidine 5 Monophosphate, Disodium
Salt 5mg; Uridine 5 Triphosphate Salt; Uridine 5 Diphosphate Disodium;
Uridine 5 Monophosphate; Disodium Salt
Ferrer International,
S.A 25th Aug 2010
15186 H2010/15186/491 Aziclar 500mg Tablets Clarithromycin Usp 500mg Flamingo
Pharmaceuticals Ltd 25th Aug 2010
18849 H2010/18849/492 Dermavin 500mg Tablets Griseofulvin Bp 500mg Flamingo
Pharmaceuticals Ltd 25th Aug 2010
21199 H2010/21199/493 Bon Hep Tablets Metadoxine 500mg Fourts (India) Labs Ltd
25th Aug 2010
21200 H2010/21200/494 Fourts B Capsules Thiamine Nitrate 12.50mg; Riboflavin
11.50mg; Pyridoxine Hcl 3.45mg;
Nicotinamide 54mg; Acorbic Acid 84.75mg; Zinc Sulfate H2o 55mg;
Chromic Chloride 1.025mg; Sodium Selenite 0.22mg; Sodium Metavanate 0.24mg; Colecalciferol 0.03mg; Acetylcysteine 25.625mg; Glycine
25mg; Glutamic Acid 27mg; Folic Acid 1.3mg
Fourts (India) Labs
Ltd 25th Aug 2010
Page 3
3rd August, 2011 THE KENYA GAZETTE 2955
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
15872 H2010/15872/495 Soluvit Novum Injection Biotin 60mcg; Nicotinamide 40mg;
Pyridoxine 4mg; Vitamin B12 5mcg; Vitamin C 100mg; Folic Acid 0.4mg;
Pantothenic Acid 15mg; Thiamine Hydrochloride 3.2mg; Vitamin B2
3.6mg
Fresenius Kabi Ab 25th Aug 2010
21607 H2010/21607/496 Epirubicina 50mg Injection Epirubicina Clorhidrato 50mg; Lactosa Monohidrato 250mg
Glenmark Pharmaceuticals
25th Aug 2010
20787 H2010/20787/497 Potassium
Chloride Injection Potassium Chloride Bp 100mg Harson Laboratories
Ltd; India 25th Aug 2010
20446 H2010/20446/498 Sodium
Bicarbonate Injection Sodium Bicarbonate Bp 8.4% W/V Harson Laboratories
Ltd; India 25th Aug 2010
21597 H2010/21597/499 Febricet C Tablets Paracetamol 330mg; Vitamin C 200mg Hemofarm 25th Aug 2010
21598 H2010/21598/500 Febricet Cold Sachet Paracetamol 500mg; Vitamin C
200mg; Pheniramine Maleate 25mg Hemofarm 25th Aug 2010
21903 H2010/21903/501 Flamar-Mx Tablets Paracetamol Bp 325mg;
Chlorzoxazone Usp 250mg; Diclofenac Potassium Bp 50mg
Indoco Remedies 25th Aug 2010
21019 H2010/21019/502 Doverin Injection Drotaverin 20mg/Ml Intas Pharmaceuticals
Ltd 25th Aug 2010
21952 H2010/21952/503 Cardoz-12.5 Tablets Carvedilol 12.5mg Ipca Laboratories Ltd 25th Aug 2010
21951 H2010/21951/504 Cardoz-25 Capsules Carvedilol Ep 25mg Ipca Laboratories Ltd 25th Aug 2010
21957 H2010/21957/505 Clopact-75 Tablets Clopidogrel Bisulfate Usp Ipca Laboratories Ltd 25th Aug 2010
21293 H2010/21293/506 Hexigel Oral Gel Chlorhexidine Gluconate Solution5.639% W/W
Ipca Laboratories Ltd 25th Aug 2010
21295 H2010/21295/507 Mucopain Oral Gel Benzocaine 20% W/W Ipca Laboratories Ltd 25th Aug 2010
20625 H2010/20625/508 Kinem 1000mg Injection Imipenem Usp 500mg; Cilastatin 500mg
Kilitch Drugs Ltd 25th Aug 2010
20623 H2010/20623/509 K-Penem 1000mg Injection Meropenem Usp 1g Kilitch Drugs Ltd 25th Aug 2010
19867 H2010/19867/510 Eritrogen 2000 Iv Injection Erythropoetin 2000 Iu Laboratorios Bago S.A 25th Aug 2010
19738 H2010/19738/511 Infa-V Ointment Metronidazole Bp 10%; Clotrimazole
Bp 2% Lark Labs Ltd; India 25th Aug 2010
21314 H2010/21314/512 Accuzon 250 Usp Injection Ceftriaxone Anhydrous 250mg Macleods Pharmaceuticals
25th Aug 2010
21676 H2010/21676/513 Provir Injection Sterile, Freeze-Dried Acyclovir As The
Sodium Salt 250mg
Curon For Makupa
Chemist 25th Aug 2010
20254 H2010/20254/514 Starpram 10mg Tablets Escitalopram 10mg Maple Pharma 25th Aug 2010
20602 H2010/20602/515 Tenofovir
Disoproxil
Fumarate/Efavirenz/Emtricitabine
Tablets Tenofovir Disoproxil Fumarate
300mg; Efavirenz 600mg;
Emtricitabine 200mg
Matrix Laboratories
Limited (A Subsidiary
Of Mylan Laboratories
25th Aug 2010
21642 H2010/21642/516 Flubiotic Dry Syrup Flucloxacillin B.P 125mg/5ml Maxim
Pharmaceuticals Ltd Manuf. By Navana
Pharmaceuticals
25th Aug 2010
21641 H2010/21641/517 Revam Kids Syrup Vitamin A Bp 2000iu; Vitamin D Bp
200iu; Vitamin C Bp 17.5mg; Vitamin B1 Bp 0.70mg; Vitamin B2 Bp
0.85mg; Vitamin6 Bp 0.35mg; Vitamin E Bp 0.35mg; Nicotinamide
Bp 9.0mg; Cod Liver Oil 100mg
Maxim
Pharmaceuticals Ltd Manuf. By Navana
Pharmaceuticals
25th Aug 2010
21580 H2010/21580/518 Paracetamol 500mg
Tablets Paracetamol 500mg Medisel (K) Ltd 25th Aug 2010
20462 H2010/20462/519 Medomox 250 Suspension Amoxicillin Trihydrate Bp 250mg Medopharm Pvt Ltd 25th Aug 2010
17990 H2010/17990/520 Euril 10mg Tablets Enalapril Maleate 10mg Medreich Plc 25th Aug 2010
17989 H2010/17989/521 Euril 5mg Tablets Enalapril Maleate 5mg Medreich Plc 25th Aug 2010
21298 H2010/21298/522 Omizec 40mg Injection Omeprazole 40mg Medreich Plc 25th Aug 2010
22094 H2010/22094/523 Glucophage Xr
500mg Tablets Metformin Chloride 500mg Merck South Africa 25th Aug 2010
22095 H2010/22095/524 Glucophage Xr
750mg Tablets Metformin Chloride 750mg Merck South Africa 25th Aug 2010
21774 H2010/21774/525 Gynosporin Cream Clotrimazole Usp 20g Nabiqasim Industries 25th Aug 2010
Page 4
THE KENYA GAZETTE 3rd August, 2011
2956
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
Vaginal (Pvt) Ltd
21243 H2010/21243/526 Naprotax
260mg/45ml Injection Paclitaxel 6mg Naprod Life Sciences 25th Aug 2010
21083 H2010/21083/527 Naxiprazol 20 Capsules Esomeprazole 20mg National Company For Pharmaceutical
Industry
25th Aug 2010
21082 H2010/21082/528 Naxiprazol 40 Capsules Esomeprazole 40mg National Company
For Pharmaceutical Industry
25th Aug 2010
21613 H2010/21613/529 Prostatin 0.4mg Capsules Tamulosin Hcl 0.4mg National Company
For Pharmaceutical Industry
25th Aug 2010
21057 H2010/21057/530 Apetimax Syrup Cyproheptadine Hcl Bp 2mg Neomedic Llc 25th Aug 2010
21600 H2010/21600/531 Lox Heavy 5% Injection Lidocaine Hydrochloride Usp 53.3mg; Dextrose Usp 75.0mg
Neon Laboratories Ltd 25th Aug 2010
21945 H2010/21945/532 Sucol Injection Suxamethonium Chloride Neon Laboratories Ltd 25th Aug 2010
20175 H2010/20175/533 Mazit 200mg/5ml Suspension Azithromycin Dihydrate Equivalent To Azithromcyin Ph.Eur/ 200mg
Neopharma; Uae 25th Aug 2010
20919 H2010/20919/534 Bactrid 228.5 Suspension Amoxicillin Trihydrate Usp
Equivalent To Amoxicillin 200mg;
Clavulanate Potassium Usp Equivalent To Clavulanic Acid 28.5mg
Nexgen Healthcare 25th Aug 2010
21488 H2010/21488/535 Nirpid 20% Injection Soybean Oil Usp 20.00g; Egg Lecithin
1.20g; Glycerol Bp 2.25mg Nirlife 25th Aug 2010
21638 H2010/21638/536 Sterilised Water
For Injection Injection Sterilized Water For Injection Bp Nirma Ltd 25th Aug 2010
21441 H2010/21441/537 Exforge Hct 10mg/160mg/12.5
mg
Tablets Amlodipine 10mg; Valsartan 160mg; Hydrochlorothiazide 12.5mg
Novartis Pharma Stein Ag
25th Aug 2010
21440 H2010/21440/538 Exforge Hct
5mg/160mg/12.5mg
Tablets Amlodipine 5mg; Valsartan 160mg;
Hydrochlorothiazide 12.5mg
Novartis Pharma
Stein Ag 25th Aug 2010
21677 H2010/21677/539 Galvus Met
50/500mg Tablets Vildagliptin; Metformin Hcl Novartis Pharma
Stein Ag 25th Aug 2010
21678 H2010/21678/540 Galvus Met
50/850mg Tablets Vildagliptin; Metformin Hcl Novartis Pharma
Stein Ag 25th Aug 2010
21679 H2010/21679/541 Galvusmet Tablets Vildagliptin; Metformin50mg/1000mg Novartis Pharma Stein Ag
25th Aug 2010
21710 H2010/21710/542 Ondavell 8mg Tablets Ondansetron Hcl 8mg Novell 25th Aug 2010
22149 H2010/22149/543 Eclamsil 5ml Injection Magnesium Sulphate 500mg Opsonin Pharma 25th Aug 2010
21443 H2010/21443/544 Paracetamol Syrup Paracetamol 120mg Orbit Consumer
Products 25th Aug 2010
21501 H2010/21501/545 Pangraf 0.5mg Capsules Tacrolimus 0.5mg Panacea Biotech 25th Aug 2010
21499 H2010/21499/546 Pangraf 1.0mg Capsules Tacrolimus 1mg Panacea Biotech 25th Aug 2010
21500 H2010/21500/547 Pangraf 5.0mg Capsules Tacrolimus 5mg Panacea Biotech 25th Aug 2010
22202 H2010/22202/548 Clinica
Mouthwash Liquid Chlorhexidine Gluconate 0.2% W/V Platinum
Pharmaceuticals (Pvt) 25th Aug 2010
22205 H2010/22205/549 Enziclor Mouth
Wash Liquid Benzydamine Hydrochloride (B.P)
0.15% W/V; Chlorhexidine Gluconate (B.P) 0.2% W/V
Platinum
Pharmaceuticals (Pvt) 25th Aug 2010
17277 H2010/17277/550 Lipix 20mg Tablets Simvastatin Usp 20mg Platinum
Pharmaceuticals (Pvt) 25th Aug 2010
22204 H2010/22204/551 Prodent Mouth
Wash Liquid Potassium Nitrate (Bp) 1% W/V Platinum
Pharmaceuticals (Pvt) 25th Aug 2010
19953 H2010/19953/552 Aminogro Capsules L-Isoleucine Usp 100mg; L-Leucine
Usp 125mg; L-Valine Usp 75mg; L-Lysine Hcl Usp 150mg; L-Methionine
Usp 25mg; L-Threonine Usp 25mg; L-Phenylalanine Usp 50mg;L-Tryptophan Usp 5mg; L-Proline Usp 25mg; L-Glutamine Usp 150mg; L-
Arginine Usp 100mg; Thiamine Hcl Bp 5mg; Riboflavin 5mg; Pyridoxine
Hcl 1.5mg; Folic Acid Bp 0.5mg;
Prisma
Pharmaceuticals Ltd 25th Aug 2010
Page 5
3rd August, 2011 THE KENYA GAZETTE 2957
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
Cyanocobalamine 5µG
21805 H2010/21805/553 Alburel 100ml Sodium Caprylate 6.65g/L Reliance Life Sciences 25th Aug 2010
21807 H2010/21807/554 Reliferon 3 Miu Injection R-Human Interferon Alpha 2b
Injection 3miu Reliance Life Sciences 25th Aug 2010
21806 H2010/21806/555 Reliferon 5 Miu Injection R-Human Interferon Alpha 2b
Injection 5miu Reliance Life Sciences 25th Aug 2010
21802 H2010/21802/556 Religrast 300mcg Solution 300mcg Of Filgrastim Concentrated Solution Ph. Eur. (Rhg-Csf) In
Acqueous Buffer
Reliance Life Sciences 25th Aug 2010
21886 H2010/21886/557 Relipoietin
4,000iu Injection Erythropoetin Concentrated Solution
Ph. Eur. 4,000iu Reliance Life Sciences 25th Aug 2010
19945 H2010/19945/558 Glucantime Injection Meglumine Antimoniate 1.5g Sanofi Aventis 25th Aug 2010
20795 H2010/20795/559 Aerinaze
2.5mg/120mg Tablets Desloratidine 2.5mg; Pseudoephedrine
120mg
Schering Plough;
Blegium 25th Aug 2010
19954 H2010/19954/560 Ximacef 100 Oral Suspension Cefixime 100mg Sigma Pharmaceuticals
25th Aug 2010
19955 H2010/19955/561 Ximacef 400mg Capsules Cefixime 400mg Sigma
Pharmaceuticals 25th Aug 2010
22093 H2010/22093/562 Hefimar Capsules Flunarizine Dihydrochloride Bp Stedman
Pharmaceuticals 25th Aug 2010
20518 H2010/20518/563 Hepa Injection Heparin Sodium Bp 5000iu (Derived
From Mucosa)
Swiss Parenterals Ltd;
India 25th Aug 2010
18765 H2010/18765/564 Cefty 400mg Tablets Cefixime Usp As Trihydtrate Equivalent To Anhydrous Cefixime
400mg
Swiss Pharma 25th Aug 2010
21980 H2010/21980/565 Telmikaa 80 Tablets Telmisartan Bp 80mg Troikaa
Pharmaceuticals Ltd 25th Aug 2010
20184 H2010/20184/566 Clarimet 500mg Tablets Clarithromycin Usp 500mg Unicure Remedies; India For Metro
Pharmaceuticals Ltd
25th Aug 2010
21556 H2010/21556/567 Dospa 125mg Tablets Mebeverine Hcl 125mg Universal Corporation
Ltd; Kenya 25th Aug 2010
20227 H2010/20227/568 Isonide 150mg Tablets Isoniazid Bp 150mg Universal Corporation Ltd; Kenya
25th Aug 2010
21475 H2010/21475/569 Lamozid Kid Tablets Lamivudine 30mg; Zidovudine 60mg Universal Corporation
Ltd; Kenya 25th Aug 2010
20491 H2010/20491/570 Nelquin Peadiatric
Drops
Peadiatric
Drops Quinine Dihydrochloride Bp 20% W/V Universal Corporation
Ltd; Kenya 25th Aug 2010
19887 H2010/19887/571 Citabol 200mg Injection Gemcitabine Hydrochloride Usp
Equivalent To Gemcitabine 200mg Venus Remedies Ltd 25th Aug 2010
19894 H2010/19894/572 Platol 50mg/100ml Injection Cisplatin 0.5mg Venus Remedies Ltd 25th Aug 2010
20766 H2010/20766/573 Jointcare Nsm Tablets Docosahexaenoic Acid 300mg;
Eicosapentaenoic Acid 60mg; Methyl Sulphonyl Methane 250mg;
Glucsamine Sulphate Kcl 500mg; Chondroitin Sulphate 50mg; Vitamin
D3 10mcg; Folic Acid 200mcg; Vitamin B12 10mcg; Zinc 5mg; Copper
0.5mg; Manganese 2mg; Selenium 60mcg; Ginger Root Extract
Equivalent To 40mg; Rose Hip 50mg
Vitabiotics Ltd 25th Aug 2010
20765 H2010/20765/574 Pregnacare Tablets Plus
Omega-3
Vitamin E 20mg; Vitamin D3 10mcg; Vitamin C 70mg; Vitamin B1 3mg;
Vitamin B2 2mg; Vitamin B3 20mg;Folic Acid 400mcg; Vitamin B12
6mcg; Biotin 150mg Pantothenic Acid 6mg; Vitamin K 70mcg; Natural
Mixed Carotenoids 2mg; Iron 17mg; Magnesium 150mg; Zinc 15mg; Iodine
140mcg; Copper 1000mcg; Selenium 30mcg; Docosahexaenoic Acid 300mg;
Eicosapentaenoic Acid 60mg
Vitabiotics Ltd 25th Aug 2010
21505 H2010/21505/575 Urgendol P Tablets Tramadol Hydrochloride Bp 37.5mg;
Paracetamol 325mg Win-Medicare Pvt 25th Aug 2010
21865 H2010/21865/576 Paragen Tablets Paracetamol 500mg Xier Kangtai 25th Aug 2010
Page 6
THE KENYA GAZETTE 3rd August, 2011
2958
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
Paracetamol
21354 H2010/21354/577 Econazine Cream Econazole Nitrate 10mg;
Traimcinolone Acetate 1mg
Y.S.P Industries;
Malaysia 25th Aug 2010
21355 H2010/21355/578 Voren Plus Topical
Topical Gel Diclofenac Sodium 50mg Y.S.P Industries; Malaysia
25th Aug 2010
21866 H2010/21866/579 Acenquine I.M/I.V Injection Heparin Sodium Bp 5000iu (Derived
From Mucosa), Benzyl Alcohol Bp
0.95% W/V (As Preservative)
Yanzhou Xier
Kangtai
Pharmaceutical Co. Ltd; China
25th Aug 2010
20724 H2010/20724/580 Recophen Suspension Chloranphenicol 125mg Zest Pharma 25th Aug 2010
20730 H2010/20730/581 Throcin Suspension Erythromycin Stearate Bp Equivalent
To Erythromycin 200mg Zest Pharma 25th Aug 2010
21571 H2010/21571/582 Amosun 125mg Oral Granules Amoxicillin (As Trihydrate) 125mg Zhuhai United Labs
(Zhongshan) Co. Ltd 25th Aug 2010
22023 H2010/22023/583 Mdp-250 Tablets Methyldopa Usp 250mg Innocia Lifesciences 25th Aug 2010
21422 H2010/21422/584 Glucose 5% Iv Injection Glucose 5% W/V Abacus Parenterals
Drugs Ltd 25th Aug 2010
21423 H2010/21423/585 Sodium Lactate Iv Injection Sodium Lactate 0.320gm Abacus Parenterals
Drugs Ltd 25th Aug 2010
21424 H2010/21424/586 Water For Injection
Injection Water For Injection Abacus Parenterals Drugs Ltd
25th Aug 2010
21421 H2010/21421/587 Sodium Chloride
Iv Injection Sodium Chloride 0.9% W/V Abacus Parenterals
Drugs Ltd 25th Aug 2010
20056 H2010/20056/588 Kamagra Oral
Jelly Jelly Kamagra Oral Jelly 100mg; Sildenafil
Oral Jelly 100mg/5g Ajanta Pharma Ltd 25th Aug 2010
21168 H2010/21168/589 Diaboric 500mg Tablets Ornidazole 500mg Amol Pharmaceuticals
Ltd 25th Aug 2010
20264 H2010/20264/590 Flagyl 500mg Pessaries Metronidazole 500mg Aventis 25th Aug 2010
21570 H2010/21570/591 Canem-0 Tablets Feropenem Sodium 200mg Cachet
Pharmaceuticals 25th Aug 2010
19680 H2010/19680/592 Terbisil Antifungal
Spray Terbinafine Hydrochloride 1% W/W Cipla Ltd 25th Aug 2010
20830 H2010/20830/593 Lycogold Capsules Lycophen 5000mcg; Vitamin A Bp
2500iu; Vitamin E Bp 10iu; Ascorbi
Acid Bp 50mg; Selenium Dioxide 70mcg; Zinc Sulphate 27.45mg
Corona Remedies 25th Aug 2010
20763 H2010/20763/594 Gemita Injection Gemcitabine Hcl 1g Dabur Pharma 25th Aug 2010
21015 H2010/21015/595 Efrodol Tablets Acetaminophen 500mg; Pyrilamine
Maleate 75mg
Efroze Chemical
Industries 25th Aug 2010
20547 H2010/20547/596 Atazor 300mg Capsules Atazanavir Sulfate Equivalent To
Atazanavir 300mg
Emcure
Pharmaceuticals Ltd 25th Aug 2010
22191 H2010/22191/597 L Montus Tablets Levocetirizine Hydrochloride 5mg;
Montelukast Sodium Equivalent To Montelukast 10mg
Fourrts Laboratories
Pvt Ltd 25th Aug 2010
21748 H2010/21748/598 Rejunuron Capsules Alpha Lipoic Acid 100mcg;
Methylcobalamin 500mcg
Fourrts Laboratories
Pvt Ltd 25th Aug 2010
21578 H2010/21578/599 Ranitidine Tablets Ranitidine Hcl 300mg Gracure
Pharmaceuticals 25th Aug 2010
22257 H2010/22257/600 Le Nadin-180 Tablets Fexofenadine Hydrochloride 180mg Gracure Pharmaceuticals
25th Aug 2010
22258 H2010/22258/601 Le Nadin-120 Tablets Fexofenadine Hydrochloride 120mg Gracure
Pharmaceuticals 25th Aug 2010
21724 H2010/21724/602 Magnesium
Sulphate Injection Magensium Sulphate I.P 500mg(50%
W/V); Water For Injection I.P Q.S Harson Laboratories 25th Aug 2010
20350 H2010/20350/603 Fendol D.S. Tablets Mefenamic Acid Bp 500mg Hikma
Pharmaceuticals Ltd 25th Aug 2010
21108 H2010/21108/604 Hemsyl-500mg Tablets Ethamsylate Bp 500mg Indoco Remedies Ltd 25th Aug 2010
21603 H2010/21603/605 Hemsyl Injection Ethamsylate Bp125mg Indoco Remedies Ltd 25th Aug 2010
22209 H2010/22209/606 Teltas-40 H Tablets Telmisartan Ph Eur 40mg;
Hydrochlorthiazide 12.5mg Intas Pharmaceuticals 25th Aug 2010
22210 H2010/22210/607 Teltas-80 H Tablets Telmisartan Ph Eur 80mg; Intas Pharmaceuticals 25th Aug 2010
Page 7
3rd August, 2011 THE KENYA GAZETTE 2959
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
Hydrochlorthiazide 25mg
22184 H2010/22184/608 Nebtas-H Tablets Nebivolol Hydrochloride Equivalent
To Nebivolol 5mg; Hydrochlorthiazide 12.5mg
Intas Pharmaceuticals 25th Aug 2010
20741 H2010/20741/609 Rapid Relief Hot
Gel Gel Menthol 5.91% W/W; Eucalyptus Oil
1.97% W/W; Methyl Salicylate 12.80% W/W; Turpentine Oil 1.47%
W/W
L'amar For Cipla Ltd;
India 25th Aug 2010
22101 H2010/22101/610 Ibuprofen 200mg Tablets Ibuprofen Bp 200mg Macleods
Pharmaceuticals 25th Aug 2010
22100 H2010/22100/611 Carbamazepine Tablets Carbamazepine Bp 200mg Macleods Pharmaceuticals
25th Aug 2010
21897 H2010/21897/612 Ciprofloxacin
500mg Tablets Ciprofloxacin Hydrochloride Usp
Equivalent To Ciprofloxacin 500mg
Macleods
Pharmaceuticals 25th Aug 2010
22001 H2010/22001/613 Omemark 40mg Injection Omeprazole Sodium Bp Equivalent To
Omeprazole 40mg Marksans Pharma Ltd 25th Aug 2010
22003 H2010/22003/614 Izole 100mg Capsules Itraconazole 100mg Marksans Pharma Ltd 25th Aug 2010
21812 H2010/21812/615 Myostigmin Injection Neostigmine 0.5mg/Ml Neon Laboratories Ltd 25th Aug 2010
21511 H2010/21511/616 Thiosol
(Thiopental
Sodium)
Injection Thiapental Sodium Bp 1g Neon Laboratories Ltd 25th Aug 2010
21512 H2010/21512/617 Thiosol 500mg Injection Thiopental Sodium Bp 500mg Neon Laboratories Ltd 25th Aug 2010
21486 H2010/21486/618 Nirmin 5-S Injection Amino Acids 5%; Sorbitol 5% Nirlife Healthcare;
India 25th Aug 2010
21072 H2010/21076/619 Pantoloc 20mg Tablets Pantoprazole 20mg Nycomed Pty 25th Aug 2010
21076 H2010/21076/620 Pantoloc 40mg Tablets Pantoprazole 40mg Nycomed Pty 25th Aug 2010
21134 H2010/21134/621 Rhogam Ultra
Filtered Plus 300mcg
Injection Human Immunoglobulin 300mcg Ortho Clinical
Diagnostics 25th Aug 2010
21555 H2010/21555/622 Aricept 10mg Tablets Donepezil Hcl 10mg Pfizer Laboratories 25th Aug 2010
17278 H2010/17278/623 Alfa-D Drops Drops Alfacelcidol 2mcg Platinum Pharmaceuticals
25th Aug 2010
21588 H2010/21588/624 Malacur 4-/320 Tablets Dihydroartemisinin 40mg;
Piperaquine Phosphate 320mg Salvat Laboratories 25th Aug 2010
18340 H2010/18340/625 Haemo Forte Iron
Tonic Ferric Ammonium Citrate Bp 1000mg;
Folic Acid Bp 11mg; Pyridoxine Hcl Bp 48mg; Thiamine Hcl Bp 24mg;
Nicotinamide Bp 220mg
Pliva Pakistan Pvt
Ltd For Royal Group 25th Aug 2010
21609 H2010/21609/626 Misoclear 200mcg Tablets Misoprostol 200mcg Sigma
Pharmaceuticals Ltd 25th Aug 2010
21524 H2010/21524/627 Tizigesic 4mg Tablets Tizanidine 4mg Unichem Laboratories 25th Aug 2010
20486 H2010/20486/628 Vital-Z Sachets Powder Anhydrous Glucose Bp 17.5g; Sucrose
Bp 14gm; Zinc Sulphate Heptahydrate Bp Equivalent
Elemental Zinc 7.5mg; Ascorbic Acid 50mg
Unicure Remedies Ltd 25th Aug 2010
21489 H2010/21849/629 Aciphin 250mg Im Injection Ceftriaxone 250mg As Sodium U.S.P Aci Limited 4th Nov. 2010
21490 H2010/21490/630 Aciphin 500mg Im Injection Ceftriaxone 500mg As Sodium U.S.P Aci Limited 4th Nov. 2010
21491 H2010/21491/631 Aciphin 1g Iv Injection Ceftriaxone 1g As Sodium U.S.P Aci Limited 4th Nov. 2010
21492 H2010/21492/632 Kacin 500 Im/Iv Injection Amikacin 500mg As Sulfate U.S.P Aci Limited 4th Nov. 2010
21493 H2010/21493/633 Kacin 100 Im/Iv Injection Amikacin 100mg As Sulfate U.S.P Aci Limited 4th Nov. 2010
21494 H2010/21494/634 Cerox-A 250 Tablets Cefuroxime 250mg As Axetil U.S.P Aci Limited 4th Nov. 2010
22190 H2010/22190/635 Diclofen 100mg Tablets Diclofenac 100mg Aglowmed Limited 4th Nov. 2010
19777 H2010/19777/636 Agophenol Capsules Chloramphenicol Bp 250mg Agog Pharma Ltd 4th Nov. 2010
21322 H2010/21322/637 Fluphenazine
25mg/Ml Injection Fluphenazine Decanoate 25mg Ambalal Sarabhai
Enterprises Ltd 4th Nov. 2010
19126 H2010/19126/638 Alphachymotrypsin
Injection Alpha Chymotrypsin 5mg Amoun Pharmaceuticals Co
4th Nov. 2010
20857 H2010/20857/639 Aurotaz-P 4.5g I Injection Piperacillin 4g; Tazobactam 0.5g Aurobindo Pharma Limited
4th Nov. 2010
Page 8
THE KENYA GAZETTE 3rd August, 2011
2960
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
14573 H2010/14573/640 Drox 500 Capsules Cefadroxil As Monohydrate 500mg Aurobindo Pharma
Limited 4th Nov. 2010
21521 H2010/21521/641 Digoxin 0.25mg Tablets Digoxin 0.25mg Aurochem Laboratories
4th Nov. 2010
21872 H2010/21872/642 Aurocol-Dm Chloramphenicol Bp 0.5% W/V;
Dexamethasone Sodium Phosphate
Bp 0.1% W/V; Phenyl Mercuric Nitrate Usp 0.002% W/V
Aurolab 4th Nov. 2010
21871 H2010/21871/643 Aurozole Econazole 2% W/V; Chlorbutol Usp
0.5% W/V; Arachis Oil B.P Qs Aurolab 4th Nov. 2010
18020 H2010/18020/644 Coro-Intro Pump Spray Glyceryl Trinitrate 0.4mg Ayrton Saunders 4th Nov. 2010
21143 H2010/21143/645 Rinatadin 150mg Tablets Ranitidine Hcl 150mg Bal Pharma Ltd 4th Nov. 2010
21140 H2010/21140/646 Ibuprofen 400mg Tablets Ibuprofen 400mg Bal Pharma Ltd 4th Nov. 2010
21456 H2010/21456/647 Rhoclone 300mcg Injection Monoclonal Anti Rho-D Immunoglobulin 300mcg
Bharat Serums And Vaccines Ltd
4th Nov. 2010
21777 H2010/21777/648 Acinet Dry Syrup Amoxicillin 125mg; Clavulanic Acid
31.25mg
Cachet
Pharmaceuticals Ltd 4th Nov. 2010
21815 H2010/21815/649 Noclot 75mg Tablets Clopidogrel Hydrogen Sulphate Usp
Equivalent To Clopidogrel 75mg
Ccl Pharmaceuticals
(Pvt) Ltd 4th Nov. 2010
20739 H2010/20739/650 Valtec 200mg Tablets Sodium Valproate Bp 200mg; Valproic
Acid Usp 87mg Cipla Ltd 4th Nov. 2010
21537 H2010/21537/651 Tna-Peri Injection Amino Acids Claris Life Sciences Ltd
4th Nov. 2010
21671 H2010/21671/652 Lactone 100mg Tablets Spironolactone 100mg Cspc Group Co. Ltd;
China For Medisel (K)
Ltd
4th Nov. 2010
21672 H2010/21672/653 Lactone 25mg Tablets Spironolactone 25mg Cspc Group Co. Ltd; China For Medisel (K)
Ltd
4th Nov. 2010
21673 H2010/21673/654 Chlorpromazine
100mg Tablets Chlorpromazine 100mg Cspc Group Co. Ltd;
China For Medisel (K) Ltd
4th Nov. 2010
21329 H2010/21329/655 Dawaclox 250mg Capsules Cloxacillin 250mg Dawa Ltd 4th Nov. 2010
21188 H2010/21188/656 Topquine Mixture Quinine Dihydrochloride 61.24mg/5ml Dawa Ltd 4th Nov. 2010
19909 H2010/19909/657 Dawanol Syrup Paracetamol Bp 120mg Dawa Ltd 4th Nov. 2010
19754 H2010/19754/658 Lum-Artem Tablets Artemether 20mg; Lumefantrine
120mg Dawa Ltd 4th Nov. 2010
21520 H2010/21520/659 Mefpar Tablets Mefenamic Acid 250mg; Paracetamol 500mg
Dawa Ltd 4th Nov. 2010
19527 H2010/19527/660 Staxim
125mg/5mg Suspension Cefuroxime 125mg Delta Pharma Ltd 4th Nov. 2010
19531 H2010/19531/661 Azo 500 Tablets Azithromycin 500mg Delta Pharma Ltd 4th Nov. 2010
22071 H2010/22071/662 Bio-Met 500 Tablets Metformin Hydrochloride Bp 500mg Devang
Pharmaceuticals Pvt
Ltd
4th Nov. 2010
22072 H2010/22072/663 Bio-Met 850 Tablets Metformin Hydrochloride Bp 850mg Devang Pharmaceuticals Pvt
Ltd
4th Nov. 2010
21319 H2010/21319/664 Levohista Tablets Cerotezine 5mg Devang
Pharmaceuticals Pvt Ltd
4th Nov. 2010
21321 H2010/21321/665 Aceclodeal 100mg Tablets Aceclogenac 100mg Devang
Pharmaceuticals Pvt Ltd
4th Nov. 2010
21631 H2010/21631/666 Miconal 2%
Topical Cream Miconazole 20gm Ecobi Farmaceuticals 4th Nov. 2010
21632 H2010/21632/667 Miconal 2%
Topical Powder Miconazole 20gm Ecobi Farmaceuticas 4th Nov. 2010
21633 H2010/21633/668 Miconal 2% Vaginal
Lavage Miconazole 200gm Ecobi Farmaceuticals 4th Nov. 2010
22160 H2010/22160/669 Kanzar H 50mg Tablets Losartan Potassium 50mg; Hydrochlorthiazde 12.5mg
Hikma Pharma S.A.E. 4th Nov. 2010
Page 9
3rd August, 2011 THE KENYA GAZETTE 2961
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
22161 H2010/22161/670 Glucoryl 2mg Tablets Glimepiride 2mg Hikma Pharma S.A.E. 4th Nov. 2010
22159 H2010/22159/671 Kanzar H 100mg Tablets Losartan Potassium 100mg;
Hydrochlorthiazide 25mg Hikma Pharma S.A.E. 4th Nov. 2010
22158 H2010/22158/672 Alkapress 10mg Tablets Amlodipine 10mg Hikma Pharma S.A.E. 4th Nov. 2010
22157 H2010/22157/673 Alkapress 5mg Tablets Amlodipine 5mg Hikma Pharma S.A.E. 4th Nov. 2010
21688 H2010/21688/674 Desodin Syrup Desloratadine Inn 2.5mg Eskayef Bangladesh
Ltd 4th Nov. 2010
12988 H2010/12988/675 Tikocin 300mg Capsules Rifampicin Bp 300mg Flamingo
Pharmaceuticals 4th Nov. 2010
21975 H2010/21975/676 Dermosone 30g Cream Betamethasone Dipropionate Cream
Usp 0.05%
Galentic Pharma
(India) Pvt Ltd 4th Nov. 2010
21757 H2010/21757/677 Aphrodis-100 Tablets Sildenafil Citrate 100mg Galpha Laboratories Ltd
4th Nov. 2010
20721 H2010/20721/678 Xmet 500 Tablets Metformin Hydrochloride Bp 500mg Glenmark
Pharmaceuticals 4th Nov. 2010
20722 H2010/20722/679 Xmet 850 Tablets Metformin Hydrochloride Bp 850mg Glenmark
Pharmaceuticals 4th Nov. 2010
20165 H2010/20165/680 Amroxol-S Syrup Ambroxol Hydrochloride B.P 15mg;
Sulbutamol Sulphate B.P 1.205mg
Gracure
Pharmaceuticals 4th Nov. 2010
20114 H2010/20114/681 Piozone-30 Tablets Pioglitazone Hydrochloride Equivalent To Pioglitazone 30mg
Gracure Pharmaceuticals
4th Nov. 2010
20115 H2010/20115/682 Piozone-15 Tablets Pioglitazone Hydrochloride
Equivalent To Pioglitazone 15mg
Gracure
Pharmaceuticals 4th Nov. 2010
20966 H2010/20966/683 Cefaclor-250 Capsules Cefaclor Usp Equivalent To
Anhydrous Cefaclor 250mg
Gracure
Pharmaceuticals 4th Nov. 2010
20936 H2010/20936/684 Aminophylline Injection Aminophylline Bp 250mg Harsons Laboratories 4th Nov. 2010
20935 H2010/20935/685 Atracurium
Besylate Injection Atracurium Besylate Usp 10mg Harsons Laboratories 4th Nov. 2010
20938 H2010/20938/686 Suxamethonium
Chloride
Injection Suxamethonium Chloride Bp 50mg Harsons Laboratories 4th Nov. 2010
21908 H2010/21908/687 Amoxicap 500
Capsules Amoxicillin (As Trihydrate) 500mg Hovid Bhd 4th Nov. 2010
22024 H2010/22024/688 Zolevox-500
Tablets Levofloxacin Hemihydrates Equivalent To Levofloxacin 500mg
Innocia Lifesciences Pvt Ltd
4th Nov. 2010
22185 H2010/22185/689 Ramitash Ht-5
Tablets Ramipril 5mg; Hydrochlorothiazide 12.5mg
Intas Pharmaceuticals Ltd
4th Nov. 2010
21956 H2010/21956/690 Glycinorm-Mr 30 Tablets Gliclazide Bp 30mg Ipca Laboratories Ltd 4th Nov. 2010
19132 H2010/19132/691 Pan-Cetriaxone
1gm
Injection Ceftriaxone Sodium Equivalent To
Ceftriaxone 1gm
Laboratoires Pan-
Pharma 4th Nov. 2010
21144 H2010/21144/692 Malarate Tablets Lumefantrine 120mg; Artemether 20mg
Laboratory And Allied 4th Nov. 2010
22012 H2010/22012/693 Adiflam Gel Diclofenac 30g Leben Laboratories 4th Nov. 2010
22008 H2010/22008/694 Ibut-200 Tablets Brufen 200mg Leben Laboratories 4th Nov. 2010
22009 H2010/22009/695 Ibut-400 Tablets Brufen 400mg Leben Laboratories 4th Nov. 2010
21832 H2010/21832/696 Coveram 5mg/5mg Tablets 3.395mg Perindopril Coresponding To
5mg Perindopril Arginine; 6.935mg Amlodipine Besilate Equivalent To
5mg Amodipine
Les Laboratores
Servier 4th Nov. 2010
21830 H2010/21830/697 Coveram
10mg/5mg Tablets Perindopril Argeine 6.935mg;
Amlodipine 5mg
Les Laboratores
Servier 4th Nov. 2010
21829 H2010/21829/698 Coveram 10mg/10mg
Tablets 6.790mg Perindopril Corresponding To 10mg Perindopril Arginine; 13.870mg
Amlodipine Besilate Equivalent To 10mg Amlodipine
Les Laboratores Servier
4th Nov. 2010
21831 H2010/21831/699 Coveram 5mg/10mg
Tablets 3.395mg Perindopril Coresponding To 5mg Perindopril Arginine; 13.870mg
Amlodipine Besilate Equivalent To 10mg Amlodipine
Les Laboratores Servier
4th Nov. 2010
21718 H2010/21718/700 Nepin Sr-20 Tablets Nifedipine 20mg Lincoln 4th Nov. 2010
Page 10
THE KENYA GAZETTE 3rd August, 2011
2962
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
Pharmaceuticals
21591 H2010/21591/701 Flucomol Capsules Paracetamol Bp 500mg;
Dextromethorpham Hydrobromide Bp 15mg; Chlorpheniramine Maleate
Bp 2mg; Phenylepherine Hydrochloride Bp 10mg
Lincoln
Pharmaceuticals 4th Nov. 2010
16216 H2010/16216/702 Flucan 150mg Tablets Fluconazole 150mg Lincoln
Pharmaceuticals 4th Nov. 2010
21771 H2010/21771/703 Primacort-100 Injection Hydrocortisone Sodium Succinate
100mg
Macleods
Pharmaceuticals 4th Nov. 2010
21901 H2010/21901/704 Paracetamol 500mg
Tablets Paracetamol 500mg Macleods Pharmaceuticals
4th Nov. 2010
21809 H2010/21809/705 Atenolol Tablets Atenolol Bp 50mg Macleods
Pharmaceuticals 4th Nov. 2010
21811 H2010/21811/706 Accuzon 1g Injection Ceftriaxone Sodium Bp Equivalent To
Ceftriaxone Anhydrous 1g
Macleods
Pharmaceuticals 4th Nov. 2010
20848 H2010/20848/707 Furomark-500 Tablets Cefuroxime Axetil U.S.P (Amorphous)
Equivalent To Cefuroxime 500mg Marksans Pharma Ltd 4th Nov. 2010
20847 H2010/20847/708 Furomark-250 Tablets Cefuroxime Axetil U.S.P (Amorphous) Equivalent To Cefuroxime250mg
Marksans Pharma Ltd 4th Nov. 2010
22088 H2010/22088/709 Tenofovir
Disolproxil
Fumarate/Lamivudine/Efavirenz
Tablets Tenofovir Disolproxil Fumarate
300mg; Lamivudine Usp 300mg;
Efavirenz 600mg
Matrix Laboratories
Ltd 4th Nov. 2010
21584 H2010/21584/710 Carbamazepine Tablets Carbamazepine 200mg Medisel (K) Ltd 4th Nov. 2010
21583 H2010/21583/711 Prednisolone 5mg Tablets Pednisolone 5mg Medisel (K) Ltd 4th Nov. 2010
21758 H2010/21758/712 Arco Tablets Naphthoquine 100mg; Artemisinin 250mg
Medisel (K) Ltd 4th Nov. 2010
22079 H2010/22079/713 Emstat 20 Tablets Atorvastatin 20mg Medopharm Ltd 4th Nov. 2010
22078 H2010/22078/714 Metformin Tablets Metformin 500mg Medopharm Ltd 4th Nov. 2010
18705 H2010/18705/715 Medcefur 250mg Tablets Cefuroxime Axetil U.S.P Equivalent
To Cefuroxime 250mg Medopharm Ltd 4th Nov. 2010
19668 H2010/19668/716 Cledomox 625 Tablets Amoxicillin 500mg And Clavulanic Acid 125mg
Medopharm Ltd 4th Nov. 2010
19669 H2010/19669/717 Cledomox 375 Tablets Amoxicillin 250 And Clavulanic Acid
125mg Medopharm Ltd 4th Nov. 2010
21378 H2010/21378/718 Trimoprim-480 Ta Tablets Sulphamethoxazole B.P 400mg;
Trimethoprim B.P 80mg Medreich Plc 4th Nov. 2010
22046 H2010/22046/719 Maxlen-70 Tablets Alendronate Sodium Trihydrate
91.37mg Mega Life Sciences 4th Nov. 2010
21290 H2010/21290/720 Nestral Er-1000 Tablets Nicotinic Acid Bp 1000mg Mega Life Sciences 4th Nov. 2010
20120 H2010/20120/721 Nilgar M-30 Tablets Pioglitazone Hydrochloride
Equivalent To Pioglitazone 30mg; Metformin Hydrochloride 500mg
Mega Life Sciences 4th Nov. 2010
20121 H2010/20121/722 Nilgar M-15 Tablets Pioglitazone Hydrochloride
Equivalent To Pioglitazone 15mg; Metformin Hydrochloride 500mg
Mega Life Sciences 4th Nov. 2010
22044 H2010/22044/723 Incros Injection Elemental Iron As Fe+3 20mg Mega Life Sciences 4th Nov. 2010
19707 H2010/19707/724 Medicoff Clear Capsules Guaifenesin 200mg; Pseudo Ephedrine Hcl 30mg; Dextromethorphon
Hydrobromide 10mg
Mega Life Sciences 4th Nov. 2010
22049 H2010/22049/725 Flexsa 1500 Sachet Glucosamine Sulphate 1500mg Mega Life Sciences 4th Nov. 2010
21055 H2010/21055/726 Nasivion 0.01%
(Mini) Nasal Solution Oxymetazoline Hydrochloride Usp
0.1mg Merck South Africa 4th Nov. 2010
21660 H2010/21660/727 Becoactin Tablets Cyproptadine Hydrochloride Usp
4mg; Vitamin B1 2mg; Vitamin B2 0.5mg; Nicotinamide P 10mg; Vitamin
B12 1mcg; Glycine Bp 40mg; Elemental Iron 8mg; Elemental Zinc 6mg
Meyers Organics Pvt 4th Nov. 2010
22047 H2010/22047/7283
Kipel 4 Tablets Montelukast Sodium Equivalent To Montelukast 4mg
Msn Labs For Mega Life Sciences Pty Ltd
4th Nov. 2010
Page 11
3rd August, 2011 THE KENYA GAZETTE 2963
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
20943 H2010/20943/729 Naprocap-500mg Tablets Capecitabine 500mg Naprod Life Sciences 4th Nov. 2010
21247 H2010/21247/730 Abingem 200 Injection Gemcitabine 200mg Naprod Life Sciences 4th Nov. 2010
21248 H2010/21248/731 Abingem 1g Injection Gemcitabine 1g Naprod Life Sciences 4th Nov. 2010
21635 H2010/21635/732 Lox 2% Local Anaesthetic
Lidocaine Hydrochloride Bp 21.3mg Neon Laboratories Limited
4th Nov. 2010
21786 H2010/21786/733 Neomet 850mg Tablets Metformin Hydrochloride Bp 850mg Neopharma 4th Nov. 2010
21787 H2010/21787/734 Neomet 1000mg Tablets Metformin Hydrochloride Bp 1000mg Neopharma 4th Nov. 2010
21785 H2010/21785/735 Neomet 500mg Tablets Metformin Hydrochloride Bp 500mg Neopharma 4th Nov. 2010
21790 H2010/21790/736 Neoday Tablets Loratadine 10mg Neopharma 4th Nov. 2010
21075 H2010/21075/737 Xefo Rapid 8mg Injection Lornoxicam 8mg Nycomed Pty 4th Nov. 2010
21073 H2010/21073/738 Xefo Rapid 8 Tablets Lornoxicam 8mg Nycomed Pty 4th Nov. 2010
21076 H2010/21076/739 Pantoloc 40mg Tablets Pantoprazole 40mg Nycomed Pty 4th Nov. 2010
22148 H2010/22148/740 Bromodel 2.5mg Tablets Bromocriptine 2.5mg Opsonin Pharma 4th Nov. 2010
20703 H2010/20703/741 Zopercin 4.5mg Injection Piperacillin 4g; Tazobactam 0.5g Orchid Healthcare Ltd 4th Nov. 2010
18438 H2010/18438/742 Rogophen 0.5% W/V
Eye Drops Chloramphenicol Bp 0.5mg Pliva Pakistan For Royal Group
4th Nov. 2010
18439 H2010/18439/743 Rogogent Eye/Ear Drops Gentamicin Sulphate Bp Equivalent
To Gentamicin 0.3% W/V
Pliva Pakistan For
Royal Group 4th Nov. 2010
21240 H2010/21240/744 Pelastin Injection Imipenem 500mg; Cilastatin Sodium
Equivalent To Cilastatin 500mg Pt Sanbe Farma 4th Nov. 2010
19988 H2010/19988/745 Claneksi Forte Suspension Amoxicillin Trihydrate Usp
Equivalent To Amoxicillin 250mg; Clavulanate Potassium 62.5mg
Pt Sanbe Farma 4th Nov. 2010
21885 H2010/21885/746 Relipoietin
2,000iu Injection 2,000iu Of Erythropoietin
Concentrated Solution Ph. Eur
Reliance Life Sciences
Pvt Ltd 4th Nov. 2010
17209 H2010/17209/747 Roaccutane 10 Capsules Isotretinoin 10mg Hoffmann-La Roche
Ltd 4th Nov. 2010
17210 H2010/17210/748 Roaccutane 20 Capsules Isotretinoin 20mg Hoffmann-La Roche Ltd
4th Nov. 2010
21526 H2010/21526/749 Coflite Syrup Diphenhydramine Hcl 7.5mg; Sodium
Citrate 28.5mg Sky Light Chemicals 4th Nov. 2010
21529 H2010/21529/750 Sky-L Gripe Sodium Bicarbonate Sky Light Chemicals 4th Nov. 2010
21528 H2010/21528/751 Phenamine Syrup Chlorpheniramine Maleate 2mg Sky Light Chemicals 4th Nov. 2010
21527 H2010/21527/752 Flagilite Suspension Metronidazole Bp 200mg (As Benzoate)
Sky Light Chemicals 4th Nov. 2010
21525 H2010/21525/753 Sky-Mol Suspension Paracetamol Bp 120mg Sky Light Chemicals 4th Nov. 2010
22207 H2010/22207/754 Ibulite 60ml Suspension Ibuprofen Bp 100mg Sky Light Chemicals 4th Nov. 2010
22208 H2010/22208/755 Albalite Suspension Albendazole Usp 400mg Sky Light Chemicals 4th Nov. 2010
20595 H2010/20595/756 Diclofenac Sodium
75mg/3ml Injection Diclofenac Sodium 75mg Spi 4th Nov. 2010
17503 H2010/17503/757 Stacef 250mg Injection Ceftriaxone Sodium U.S.P Equivalent
To Ceftriaxone 250mg Stallion Laboratories 4th Nov. 2010
17505 H2010/17505/758 Cestazid 1000mg Injection Ceftazidine U.S.P 1000mg Stallion Laboratories 4th Nov. 2010
17504 H2010/17504/759 Stacef 1000mg For Injection Ceftriaxone Sodium U.S.P Equivalent
To Ceftriaxone 1000mg Stallion Laboratories 4th Nov. 2010
18662 H2010/18662/760 Efavirenz 200mg Tablets Efavirenz 200mg Strides Arcolab Ltd 4th Nov. 2010
20517 H2010/20517/761 Keta Injection Ketamine Hcl Usp Equivalent To
Ketamine 50mg Swiss Parenterals Ltd 4th Nov. 2010
18186 H2010/18186/762 Bactacef 1gm Injection Sulbactam Sodium Usp Equivalent To Sulbactam 0.5gm; Cefoperazone
Sodium Usp Equivalent To Cefoperazone 0.5gm
Swiss Parenterals Ltd 4th Nov. 2010
17675 H2010/17675/763 Calxy-625 Tablets Amoxicillin Trihydrate Bp Equivalent
Amoxicillin 500mg; Clavulanate
Potassium Usp Clavulanic Acid 125mg
Swiss Pharma Pvt Ltd 4th Nov. 2010
21455 H2010/21455/764 Antiplatt Plus 150 Tablets Clopidogrel 75mg; Aspirin Usp 150mg Troikaa Laboratories 4th Nov. 2010
20945 H2010/20945/765 Troypofol I.V 1%
W/V Injection Propofol Bp 10,G Troikaa Laboratories 4th Nov. 2010
Page 12
THE KENYA GAZETTE 3rd August, 2011
2964
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
21340 H2010/21340/766 Telsar 80 Tablets Telmisartan 80mg Unichem Laboratories
Ltd 4th Nov. 2010
20815 H2010/20815/767 Corbis-H5 Tablets Bisoprol Fumarate Usp 5mg; Hydrochlorothiazide Usp 6.25mg
Unichem Laboratories Ltd
4th Nov. 2010
21523 H2010/21523/768 Tizigesic 2mg Tablets Tizanidine Hcl 2mg Unichem Laboratories
Ltd 4th Nov. 2010
21789 H2010/21789/769 Neoxicam 15 Tablets Meloxicam 15mg Neopharm 4th Nov. 2010
21788 H2010/21788/770 Neoxicam 7.5 Tablets Meloxicam 7.5mg Neopharm 4th Nov. 2010
19688 H2010/19688/771 Calamine Lotion Calamine 15%; Zinc Oxide 5% Universal Corporation 4th Nov. 2010
20488 H2010/20488/772 Virom 20mg Capsules Omeprazole Bp 20mg Virchow Healthcare
Ltd 4th Nov. 2010
21864 H2010/21864/773 Carbagen Tablets Carbamazepine 200mg Yanzhou Xier Kangtai
Pharmaceuticals Co. Ltd For Shanghai
Agen Int. Trade Co. Ltd
4th Nov. 2010
21867 H2010/21867/774 Ceftriagen 1g B.-
Im/Iv Injection Ceftriaxone Sodium Bp Equivalent To
Ceftriaxone 1g
Yanzhou Xier
Kangtai
Pharmaceuticals Co. Ltd For Shanghai
Agen Int. Trade Co. Ltd
4th Nov. 2010
21938 H2010/21938/775 Gentagen Im/Iv Injection Gentamycin 80mg/2ml Yanzhou Xier
Kangtai Pharmaceuticals Co.
Ltd For Shanghai Agen Int. Trade Co.
Ltd
4th Nov. 2010
20728 H2010/20728/776 Zeecid Tablets Dried Aluminium Hydroxide Gel Bp
120mg; Magnessium Trisilicate Bp 250mg
Zest Pharma 4th Nov. 2010
21752 H2010/21752/777 Imich Cream Imiquimod 50mg Zhuhai Ltd 4th Nov. 2010
21727 H2010/21727/778 Loradine Tablets Loratadine 10mg Y.S.P Industries 4th Nov. 2010
22192 H2010/22192/779 Tasone 15g Cream Bentamethasone Diproprionate Cream Usp 0.065% W/W
Centaur Pharmaceuticals
4th Nov. 2010
21896 H2010/21896/780 Breathezy 10 Tablets Montelukast Sodium Equivalent To
Montelukas 10mg Msn Laboratories Ltd 4th Nov. 2010
22193 H2010/22193/781 Netasole Cream Betamethasone (As 17-Valerate) Bp
0.1g; Neomycin Sulphate Bp 0.5g
Centaur
Pharmaceuticals 4th Nov. 2010
21894 H2010/21894/782 Safetelmi 40 Tablets Telmisartan Ph. Eur. 40mg Msn Laboratories Ltd 4th Nov. 2010
21893 H2010/21893/783 Ldnil 10 Tablets Rosuvastatin 10mg Msn Laboratories Ltd 4th Nov. 2010
22226 H2010/22226/784 Aurosol Eye Drops Hypromellose 7.0% W/V Aurolab 4th Nov. 2010
21810 H2010/21810/785 Omepraz-20 Capsules Omeprazole Bp 20mg Macleods Pharmaceuticals
4th Nov. 2010
21297 H2010/21297/786 Panadol
240mg/5ml Elixir Syrup Paracetamol 120mg Glaxosmithkline 4th Nov. 2010
20441 H2010/20441/787 Finfive Tablets Finasteride Usp 5mg Unicure Remedies Ltd 4th Nov. 2010
21895 H2010/21895/788 Plasep Tablets Clopidogrel Bisulfate Usp 75mg Msn Laboratories Ltd 4th Nov. 2010
21944 H2010/21944/789 Indoplant Implant Levonogestrel 75mg Pt-Triyasa Nagamas 4th Nov. 2010
21976 H2010/21976/790 Tx-Eye Ointment Tetracycline 1% W/W Galentic Pharma
(India) Pvt Ltd 4th Nov. 2010
22195 H2010/22195/791 Entezma Ointment Betamethasone 0.5mg; Salicylic Acid Bp 30mg
Centaur Pharmaceuticals
4th Nov. 2010
21531 H2010/21531/792 Allerfast 180mg Tablets Fexofenadine Hcl 180mg Khandelwal
Laboratories Ltd 4th Nov. 2010
21742 H2010/21742/793 Carefenac 100mg Tablets Diclofenac Sodium 100mg Shanxi Guangsheng 4th Nov. 2010
18413 H2010/18413/794 Bonestat Capsules Calcium Carbonate Bp 500mg
Equivalent To Elemental Calcium 200mg, Zinc Sulphate H20 Usp 7.5, Calcitriol Bp 0.25mcg
Indichemie Health
Specialities Ltd 4th Nov. 2010
21154 H2010/21154/795 Telmimark 80 Tablets Telmisartan 80mg Marksans Pharma Ltd 4th Nov. 2010
Page 13
3rd August, 2011 THE KENYA GAZETTE 2965
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
21741 H2010/21741/796 Brufol-200mg Tablets Ibuprufen 200mg Shanxi Guangsheng 4th Nov. 2010
21155 H2010/21155/797 Telmimark 40 Tablets Telmisartan 40mg Marksans Pharma Ltd 4th Nov. 2010
21747 H2010/21747/798 Brufol-400mg Tablets Ibuprufen 400mg Shanxi Guangsheng 4th Nov. 2010
21156 H2010/21156/799 Acixx Suspension Magaldrate 480mg; Simethicone 25mg Marksans Pharma Ltd 4th Nov. 2010
18412 H2010/18412/800 Celfast Tablets Aceclofenac Bp 100mg; Paracetamol
Bp 500mg
Indichemie Health
Specialities Ltd 4th Nov. 2010
19969 H2010/19969/801 Fantem Suspension Artemether 0.180g; Lumefantrine 1.080g Per 60ml
Madras For Medinomics
Healthcare Pvt Ltd
4th Nov. 2010
20858 H2010/20858/802 Pozineg 2000 Injection Cefepime 2000mg Aurobindo Pharma
Limited 4th Nov. 2010
20778 H2010/20778/803 Meromark 1g Injection Meropenem Trihydrate U.S.P Equivalent To Anhydrous Meropenem
1g, Sodium Carbonate Equivalent To Sodium 90.2mg
Marksans Pharma Ltd 4th Nov. 2010
21462 H2010/21462/804 Ramicip-H Tablets Ramipril 2.5mg, Hydrochlorthiazide
12.5mg Cipla Ltd 2nd Dec 2010
21798 H2010/21798/805 Sterimax 2.5% V/V Chlorhexidine Gluconate
Solution Ip, 0.5% W/V Triclosan Usp, 50% V/V Isopropyl Alcohol (2-
Propanol) Bp, Skin Emollients, Perfume, Brilliant Blue Fcf As Colour
Coral Clinical Systems 2nd Dec 2010
21799 H2010/21799/806 Endomax Solution Glutaraldehyde 2.45% W/V Coral Clinical Systems 2nd Dec 2010
21800 H2010/21800/807 Endomax 2.0 Solution Glutaraldehyde 2% W/V Coral Clinical Systems 2nd Dec 2010
20605 H2010/20605/808 Fenplus Tablets Ibuprofen Bp 400mg, Paracetamol Bp
325mg Coral Laboratories 2nd Dec 2010
21732 H2010/21732/809 Clavodran 625mg Tablets Amoxicillin 500mg, Clavulanic Acid 125mg
Dar Al Dawa, Nau'r Jordan
2nd Dec 2010
21733 H2010/21733/810 Clavodran 1mg Tablets Amoxicillin 875mg, Clavulanic Acid
125mg
Dar Al Dawa, Nau'r
Jordan 2nd Dec 2010
18731 H2010/18731/811 Cetriz Syrup Cetrizine Hydrochloride Bp 5mg Dawa Limited 2nd Dec 2010
21691 H2010/21691/812 Zofra Odt 4 Tablets Ondansetron Usp 4mg Eskayef Bangladesh
Ltd 2nd Dec 2010
21692 H2010/21692/813 Carbazin Cr Tablets Carbamazepine 200mg Eskayef Bangladesh
Ltd 2nd Dec 2010
20622 H2010/20622/814 Vitalipid
Novumadult Injection Vitamin A 99µG, Vitamin D2 0.5µG,
Vitamin E 0.91mg, Vitamin K1 15µG Fresenius Kabi 2nd Dec 2010
19579b H2010/19579b/815
Co-Tasmi 80mg/12.5mg
Tablets Telmisartan 80mg, Hydrochlorthiazide 12.5mg
Getz Pharma 2nd Dec 2010
22249 H2010/22249/816 Fungiter Cream Terbinafine Hydrochloride Bp 1%
W/W
Global Pharma
Healthcare Pvt Ltd 2nd Dec 2010
22035 H2010/22035/817 Rostat-5 Tablets Rosuvastatin Calcium Equivalent To
Rosuvastatin 5mg
Innocia Lifesciences
Pvt Ltd 2nd Dec 2010
22028 H2010/22028/818 Cetlevo-5 Tablets Levocetirizine Dihydrochloride 5mg Innocia Lifesciences
Pvt Ltd 2nd Dec 2010
22022 H2010/22022/819 Rostat-10 Tablets Rosuvastatin 10mg Innocia Lifesciences Pvt Ltd
2nd Dec 2010
22021 H2010/22021/820 Rabosec -20 Tablets Rabeprazole Sodium 20mg Innocia Lifesciences
Pvt Ltd 2nd Dec 2010
20784 H2010/20784/821 Maclair-10 Tablets Montelukast Sodium Equivalent To
Montelukast 10mg
Mac Heal Laboratories
Ltd 2nd Dec 2010
22097 H2010/22097/822 Zinc Sulfate Tablets Elemental Zinc 20mg Macleods
Pharmaceuticals 2nd Dec 2010
16747 H2010/16747/823 Oflomac I.V Injection Oloxacin Usp 200mg Macleods Pharmaceuticals
2nd Dec 2010
20617 H2010/20617/824 Paracetamol
Infusion 10mg/Ml Injection Paracetamol Bp 10mg Marck Biosciences Ltd 2nd Dec 2010
21913 H2010/21913/825 Hipoflox Eye/Ear Drops
Drops Ofloxacin U.S.P 0.3% W/V, Benzalkonium Chloride N.F 0.01% W/V
Marck Biosciences Ltd 2nd Dec 2010
20639 H2010/20639/826 Bactrid Suspension 100mg Cefixime U.S. P Medicraft
Pharmaceuticals (Pvt) 2nd Dec 2010
Page 14
THE KENYA GAZETTE 3rd August, 2011
2966
Appl.
No.
Proposed Reg.
No. Trade Name Dosage Form Active Ingredients Market Authorisation
Holder Date Of Reg
Ltd
20640 H2010/20640/827 Bactrid 400mg Capsules 400mg Cefixime U.S. P Medicraft
Pharmaceuticals (Pvt) Ltd
2nd Dec 2010
21292 H2010/21292/828 Rocimus 0.03%
W/W Ointment Tacrolimus Ointment 0.03% Mega Products Ltd 2nd Dec 2010
21513 H2010/21513/829 Neocuron Injection Pancuronium 2m/Ml Neon Labs 2nd Dec 2010
21149 H2010/21149/830 Pirsek 20/1100mg Capsules Omeprazole 20mg, Sodium
Bicarbonate 1100mg
Norwich
Pharmaceuticals For Glaxosmithkline
2nd Dec 2010
21150 H2010/21150/831 Pirsec 40/1100mg Capsules Omeprazole 40mg, Sodium
Bicarbonate 1100mg
Norwich
Pharmaceuticals For
Glaxosmithkline
2nd Dec 2010
21074 H2010/21074/832 Pantoloc 40mg Injection Pantoprazole 40mg Nycomed 2nd Dec 2010
20108 H2010/20108/833 Benylin Wet
Cough Expectorant
Syrup Guaifenesin 100mg Johnson&Johnson For
Surgipharm Limited. 2nd Dec 2010
20109 H2010/20109/834 Benylin Wet
Cough Expectorant
Syrup Guaifenesin 200mg Johnson&Johnson For
Surgipharm Limited. 2nd Dec 2010
19254 H2010/19254/835 Benlin For Colds Tablets Pseudoephedrine Hcl 30mg, Ibuprofen
200mg Pfizer Healthcare Ltd 2nd Dec 2010
19224 H2010/19224/836 Unistem V-1
Vaginal Tablets And Unisten
Cream
Tablets/Cream Clotrimazole Bp 500mg, Clotrimazole
Bp 1%
Regal
Pharmaceuticals Ltd 2nd Dec 2010
21857 H2010/21857/837 E-Gel Ds Capsules Vitamin E Usp 400 I.U Renata Limited 2nd Dec 2010
21852 H2010/21852/838 Gaba 300mg Tablets Gabapentin 300mg Renata Limited 2nd Dec 2010
21859 H2010/21859/839 E-Gel Capsules Vitamin-E Usp 200 I.U Renata Limited 2nd Dec 2010
21419 H2010/21419/840 Clexane Mdv 300mg/3ml
Injection Enoxaparin Sodium 300mg Sanofi Aventis 2nd Dec 2010
21698 H2010/21698/841 Coaprovel
300/25mg Tablets Irbesartan 300mg,
Hydrochlorothiazide 25mg Sanofi Aventis 2nd Dec 2010
21697 H2010/21697/842 Amaryl M Sr Tablet Glimepiride, Metformin Hydrochloride Sanofi Aventis 2nd Dec 2010
21701 H2010/21701/843 Zobenol 400mg Tablets Albendazole 400mg Sanofi Aventis -
Withrop Pharm 2nd Dec 2010
16238 H2010/16238/844 Indomethacin Capsules Indomethacin Bp 25mg Sishui Xierkang For
Royal Group 2nd Dec 2010
21914 H2010/21914/845 Neodex Eye/Ear
Drops Drops Neomycin Sulphate, Dexamethasone
Sodium Phosphate Marck Biosciences Ltd 2nd Dec 2010
22132 H2010/22132/846 Memox Tablets Mebendazole U.S.P 100mg Universal Corporation 2nd Dec 2010
22128 H2010/22128/847 Memox Suspension Mebendazole U.S.P 100mg Universal Corporation 2nd Dec 2010
21212 H2010/21212/848 Clotrimazole
(20gm) Cream Clotrimazole 1% W/W Vital Healthcare Ltd 2nd Dec 2010
21226 H2010/21226/849 Adrivit Injection Adrenaline Bitartrate Bp Equivalent
To Adrenalline 1mg, Water For Injection Bp Q.S
Vital Healthcare Ltd 2nd Dec 2010
21215 H2010/21215/850 Metovit Injection Metochlorpramide 20mg Vital Healthcare Ltd 2nd Dec 2010
PRODUCTS REGISTERED IN JULY TO DECEMBER, 2010 VET
Appl. No.
Proposed Reg. No. Trade Name Dosage Form Active Ingredients Market Authorization
Holder
Date of Reg.
21941 V2010/21941/24 Ashtyl 20% Powder Tylosin 20% W/W Ashish Life
Sciences Pvt 25th Aug. 2010
21935 V2010/21935/25 Ashoxy 20% Powder Oxytetracycline Hcl Bp 200mg Ashish Life Sciences Pvt
25th Aug. 2010
21348 V2010/21348/26 Albendazole 10% Suspension Albendazole 100mg Assia Animal
Health 25th Aug. 2010
21349 V2010/21349/27 Albendazole 2.5% Suspension Albendazole 25mg Assia Animal
Health 25th Aug. 2010
Page 15
3rd August, 2011 THE KENYA GAZETTE 2967
Appl.
No. Proposed Reg. No. Trade Name Dosage Form Active Ingredients Market
Authorization Holder
Date of Reg.
13733 V2010/13733/28 Wormizan Plus Suspension Levamisole Hydrochloride Bp
Vet 1.5% W/V; Oxyclozanide Bp
Vet 3.0% W/V Vet
Biodeal
Laboratories
Limited
25th Aug. 2010
19617 V2010/19617/29 Butaline Injection Buparvaquone 50mg Ceva Sante Animale 25th Aug. 2010
21387 V2010/21387/30 Dawafer Injection Iron Dextran 10% W/V Chongqing
Fangtong For Dawa Limited
25th Aug. 2010
21627 V2010/21627/31 Damectin 1% Injection Ivermectin 100mg Dawa Ltd 25th Aug. 2010
21605 V2010/21605/32 Dabendazole 300mg Tablets Albendazole Usp 300mg Dawa Ltd 25th Aug. 2010
21725 V2010/21725/33 Dabendazole 2500mg Bolus Albendazole Usp 2500mg Dawa Ltd 25th Aug. 2010
21891 V2010/21891/34 Dawaboost Injection Vitamin A 15000iu; Vitamin E
20mg; Vitamin D3 1000iu; Vitamin B1 10mg; Vitamin B2
5mg; Vitamin B6 3mg; Vitamin B12 50mcg; Vitamin B3 35mg;
Vitamin B5 25mg
Chongqing
Fangtong For Dawa Ltd
25th Aug. 2010
19642 V2010/19642/35 Trisulmycine Forte Powder Trimethoprim 13.3gm; Sulphadiazine Sodium
Equivalent To Sulphadiazine 67.7gm
Laprovet Company 25th Aug. 2010
17908 V2010/17908/36 Canazol-2.5% Suspension Albendazole Usp 25mg Nerix Pharma For
Pamoja Vetagro
Services
25th Aug. 2010
21176 V2010/21176/37 Diadin Injectable Injection Sulphadimidine Sodium Bp 0.333gm
Renata Ltd 25th Aug. 2010
21983 V2010/21983/38 Wofur Injection Ceftiofur 50mg/Ml Wockhardt Limited 25th Aug. 2010
21201 V2010/221201/39 Iron D Injection Iron Dextran 100mg Eagle Vet Tech. Co. Ltd
4th Nov. 2010
20430 V2010/20430/40 Tylo Pc Injection Tylosin Tartarate 57.5mg;
Thiamphenicol 200mg;
Prednisolone 5.0mg
Eagle Vet Tech. Co.
Ltd 4th Nov. 2010
20684 V2010/20684/41 Clopidol 25 Veterinary
Powder Clopicol 250gm Koffolk (1949) Ltd For Abic
4th Nov. 2010
21171 V2010/21171/42 Helmex Tablets Albendazole Usp 600mg Renata 4th Nov. 2010
21068 V2010/21068/43 Cevac Ibd L Injection Infectious Bursal Disease Vaccine
Ceva Sante Animale 4th Nov. 2010
22201 V2010/22201/44 Avi Pro Nd-Ibd Lasota Injection 108 Nd Virus, Strain La Sota 10
3
Eid50 Ib Virus
Lohman Animal
Health 4th Nov. 2010
20993 V2010/20993/45 Norodine Tablets Sulphadiazine Usp 1g;
Trimethoprim Usp 200mg Norbrook Labs 4th Nov. 2010
21611a V2010/21611a/46 Altramycin La Injection Oxytetracycline Dehydrate B.P
Equivalent To Oxytetracycline (On Anhydrous Basis) 200mg; 2-
Pyrroliodone Q.S
Vetnex Animal
Health Limited 4th Nov. 2010
22263 V2010/22263/047 Levanide Injection Levamisole Hcl Bp 15mg, Rafoxanide Bp 30mg
Nerix Pharma Ltd For Megascope
2nd Dec 2010
20840 V2010/20840/048 Levazole Drench Levamizole Hcl 1.5% W/V Medina Chemicals 2nddec 2010
18311 V2010/18311/049 Bomatak Pour On Liquid Oxfendazole 75gm Bomac Laboratories 2nd Dec 2010
F. M. SIYOI,
Deputy Registrar.
Page 16
THE KENYA GAZETTE 3rd August, 2011
2968
PRINTED AND PUBLISHED BY THE GOVERNMENT PRINTER, NAIROBI