GAZETTE NOTICE NO. 14431

THE PHARMACY AND POISONS (REGISTRATION OF DRUGS) RULES THE PHARMACY AND POISONS BOARD PRODUCTS REGISTERED FROM JULY TO DECEMBER, 2011–HUMAN Application No. Registration No. Trade Name Dosage Form Active Ingredients Market Authorisation Holder Date of Registration 22033 H2011/22033/420 Dacillin 300 Capsules Clindamycin Hcl Bp Equivalent To Clindamycin 300mg Innocia Lifesciences Pvt Ltd 6th October 2011 22016 H2011/22016/427 Optimal Mouthwash Povidone Iodine Usp 1% Oss-Chemie (K) Ltd 6th October 2011 22057 H2011/22057/363 G-Alfenac Suppositories Aceclofenac Bp 100mg Bliss Gvs 6th October 2011 22057 H2011/21303/364 Gen-Levo Tablets Levofloxacin 500mg Brooks Pharmaceuticals Ltd 6th October 2011 20744 H2011/20744/365 Azee Injection Azithromycin Usp 500mg Cipla Ltd 6th October 2011 20618 H2011/20618/368 Keftaz Injection Ceftazidime Usp 1000mg Galpha Laboratories 6th October 2011 22032 H2011/22032/376 Dacillin 150 Capsules Clindamycin Hcl Bp Equivalent To Clindamycin 150mg Innocia Lifesciences 6th October 2011 20472 H2011/20472/378 Labvir 200 Tablets Acyclovir Bp 200mg Laboratory & Allied Ltd 6th October 2011 20473 H2011/20473/379 Labvir 400 Tablets Acyclovir Bp 400mg Laboratory & Allied Ltd 6th October 2011 22099 H2011/22099/380 Fluconazole Tablets Fluconazole Usp 150mg Macleods Pharmaceuticals Ltd 6th October 2011 22080 H2011/22080/388 Ortiza Tablets Azithromycin 500mg Medopharm Ltd 6th October 2011 21855 H2011/21855/396 Furocef Injection Cefuroxime 750mg Renata Limited 6th October 2011 20991 V2011/20991/023 Closamectin Pour On Solution Ivermectin Ph. Eur. 0.5% W/V; Closantel Ph. Eur. 20.0% W/V Norbrook Laboratories 1st September 21876 V2011/21876/024 Buprocip Injection Buparvaquone 50mg Cipla Limited 6th October 2011 21192 V2011/21192/025 Fasoverm Suspension Oxyclozanide Bp 3% W/V; Dawa Limited 6th October 2011 THE KENYA GAZETTE 12th October, 2012 3860 3860 Application No. Registration No. Trade Name Dosage Form Active Ingredients Market Authorisation Holder Date of Registration Levamisole Hcl Bp 1.5% W/V; Cobalt Sulphate 0.382% W/V 21301 V2011/21301/026 Fasoverm-Ds Suspension Oxyclozanide Bp 6% W/V; Levamisole Hcl Bp 3% W/V; Cobalt Sulphate 0.764% W/V Dawa Limited 6th October 2011 22262 V2011/22262/027 Ivermin Injection Ivermectin Ep 1% W/V; Benzyl Alcohol Bp 3% W/V Hebei Yuanzheng Pharm. Co. Ltd 6th October 2011 21010 V2011/21010/028 Oxytetracycline 10% Injection Oxytetracycline Hydrochloride 100mg Nerix Pharma 6th October 2011 17670 H2011/17670/442 Apdyl-H Cough Syrup Vasaka (Adhatoda Vasika) 150mg; Yashitimadhu (Glycyrrhiza Glabra) 75mg; Pippali (Piper Longum) 10mg; Kulinjan (Alpinia Galangal) 100mg Ajanta Pharma 1st December CTD249 H2011/CTD249/362 Lamivudine/Tenof ovir Tablets Lamivudine 300mg; Tenofovir 300mg Aurobindo Pharma Ltd 1st December CTD221 H2011/CTD221/369 Emtricitabine & Tenofovir Fumarate Tablets Emtricitabine 200mg; Tenofovir Fumarate 300mg Hetero Drugs Ltd 1st December CTD231 H2011/CTD231/370 Lamivudine & Zidovudine Tablets Lamivudine 150mg; Zidovudine 300mg Hetero Drugs Ltd 1st December CTD232 H2011/CTD232/371 Nevirapine Tablets Nevirapine 200mg Hetero Drugs Ltd 1st December CTD229 H2011/CTD229/372 Valovir Tablets Valaciclovir Hydrochloride Eq. To Valaciclovir 500mg Hetero Drugs Ltd 1st December CTD223 H2011/CTD223/373 Lopinavir & Ritonavir Tablets Lopinavir 200mg; Ritonavir 50mg Hetero Drugs Ltd 1st December CTD219 H2011/CTD219/374 Romycin Tablets Azithromycin 500mg Ibn Sina 1st December CTD067 H2011/CTD067/392 Starval 160/25 Tablets Valsartan 160mg; Hydrochlorothiaziade 25mg Ranbaxy Laboratories 1st December CTD068 H2011/CTD068/393 Starval 80/12.5 Tablets Valsartan 80mg; Hydrochlorothiazide 12.5mg Ranbaxy Laboratories 1st December CTD069 H2011/CTD069/394 Starval 160 Tablets Valsartan 160mg Ranbaxy Laboratories 1st December CTD070 H2011/CTD070/395 Starval 80 Tablets Valsartan 80mg Ranbaxy Laboratories 1st December 21737 H2011/21737/298 Cefurome Tablets Cefuroxime Axetil 500mg Augment Remedies Ltd 14th July 2011 17855 H2011/17855/307 Falcinil Injection Artesunate 60mg Cipla Limited 14th July 2011 21466 H2011/21466/326 Bactoclav Tablets Amoxycillin Trihydrate Bp Equivalent To Amoxicillin 875mg; Clavulanate Potassium Bp Equivalent To Clavulanic Acid 125mg Micro Labs Limited 14th July 2011 21921 H2011/21921/310 Ampimed Injection 250mg Of Ampicillin Bp As Sodium Salt Cspc Group Co. Ltd For Medisel (K) Ltd 4th August 2011 21921 H2011/CTD017/313 Leflox Injection Levofloxacin 750mg Getz Pharma 4th August 2011 CTD107 H2011/CTD107/314 Epiproate Cr Tablets Sodium Valproate 145mg; Valproic Acid 333mg Glaxosmithkline 4th August 2011 20420 H2011/20420/320 Micro-Novum Tablets Norethisterone 0.35mg Jassen-Cilag 4th August 2011 21719 H2011/21719/321 Strom Injection Tramadol Hcl 100ml Lincoln Pharmaceuticals 4th August 2011 18888 H2011/18888/322 Indapa Sr Tablets Indapamide Usp 1.5mg M.J Biopharm Pvt Ltd 4th August 2011 21926 H2011/21926/325 Sodium Bicarbonate Injection Sodium Bicarbonate Bp 8.4% W/V Cspc Group Co. Ltd For Medisel (K) Ltd 4th August 2011 21656 H2011/21656/334 Orthofen Sr Tablets Aceclofenac B.P 200mg Prism Life Sciences Ltd 4th August 2011 18911 H2011/18911/344 Diaphage Tablets Metformin Hcl Bp 850mg Universal Corporation Ltd 4th August 2011 21752 H2011/21752/348 Imich Cream Imiquimod 2g Zhuhai Ltd 4th August 2011 21878 H2011/21878/295 Adco Midazolam Injection Midazolam 15mg/3ml Adcock Ingram 4th August 2011 19279 H2011/19279/297 Amphotericin B Injection Amphotericin B Usp 50mg Ambalal Sarabhai Ent. Ltd 4th August 2011 22215 H2011/22215/308 Precob Capsules Pregabalin 75mg; Methylcobalamin 750mg Corona Remedies For Medisel (K) Ltd 4th August 2011 13922 H2011/13922/309 Clindamycin Capsules Clindamycin Phosphate 150mg Cosmos Ltd; Kenya 4th August 2011 20895 H2011/20895/315 Grasozole Tablets Esomeprazole Magnesium 40mg Gracure Pharmaceuticals Ltd 4th August 2011 22102 H2011/22102/323 Tinidazole Tablets Tinidazole Bp 500mg Macleods Pharmaceuticals 4th August 2011 21898 H2011/21898/324 Ciprofloxacin Tablets Ciprofloxacin Hydrochloride Usp Equivalent to Ciprofloxacin 250mg Macleods Pharmaceuticals 4th August 2011 21191 H2011/21191/330 Paclitaxel Injection Paclitaxel 6mg/Ml Pharmachemie Bv Netherlands For Teva Pharmaceuticals 4th August 2011 12th October, 2012 THE KENYA GAZETTE Application No. Registration No. Trade Name Dosage Form Active Ingredients Market Authorisation Holder Date of Registration 21190 H2011/21190/331 Abitrexate Injection Methotrexate 1gm Pharmachemie Bv Netherlands For Teva Pharmaceuticals 4th August 2011 19633 H2011/19633/332 Erilide Tablets Erythromycin 500mg Plethico Pharmaceuticals 4th August 2011 2185 H2011/21856/335 Furocef Tablets Cefuroxime 250mg Renata Limited 4th August 2011 20493 H2011/20493/340 Claxy Tablets Amoxycillin Trihydrate Bp Equivalent To Amoxicillin 875mg; Potassium Clavulanate Usp Equivalent To Clavulanic Acid 125mg Swiss Parenterals Ltd; India 4th August 2011 21253 H2011/21253/341 Abic Leucovorin Injection Leucovorin Acid 30mg Teva Pharmaceuticals 4th August 2011 20287 H2011/20287/316 Cephalexin Capsules Cephalexin Bp Equivalent To Cephalexin Anhydrous 500mg Gracure Pharmaceuticals Ltd For Regency Pharmaceuticals 4th August 2011 CTD110 H2011/CTD110/329 Novasept Powder Povidone Iodine 5% W/V Navketan Research Labs 4th August 2011 21821 H2011/21821/401 Asdoxin Capsules Doxycycline Hyclate Bp Equivalent To Doxycycline 100mg Astra Life Care Pvt Ltd 1st September 18119 H2011/18119/404 Efavirenz Capsules Efavirenz 200mg Aurobindo Pharma 1st September 18120 H2011/18120/405 Lamivudine Zidovudine/Efavire nz Tablets Lamivudine 150mg; Zidovudine 300mg; Efavirenz 600mg Aurobindo Pharma 1st September 18117 H2011/18117/406 Efavirenz Capsules Efavirenz 50mg Aurobindo Pharma 1st September 17250 H2011/17250/407 Evafirenz Tablets Evavirenz 600mg Aurobindo Pharma 1st September 22073 H2011/22073/408 Reteflex Plus Injection Spectinomycin Hcl 2gm Bharat Parenterals Ltd 1st September CTD278 H2011/CTD278/409 Tizole Tablets Tinidazole 500mg Biodeal Laboratories 1st September 21304 H2011/21304/412 Gen-Levo Iv Injection Levofloxacin 500mg Brooks Pharmaceutical Laboratories Ltd 1st September 21749 H2011/21749/413 Neo-Klar Suspension Clarithromycin 125mg/5ml Ccl Pharmaceuticals Pvt Ltd 1st September 18062 H2011/18062/417 Avalon Nf Cream Neomycin Sulfate Bp 1% W/W; Fluocinolone Acetonide Bp 0.025 W/W Galentic Pharma 1st September 21795 H2011/21795/418 Tinicure Tablets Tinidazole 500mg Galpha Laboratories 1st September 22256 H2011/22256/419 Xime-Od Tablets Cefixime Usp 400mg As Trihydrate Gracure Pharmaceuticals 1st September CTD292 H2011/CTD292/422 Feromax Injection Elemental Iron 100mg As Iron Sucrose Complex Julphar, Gulf Pharmaceutical 1st September 22037 H2011/22037/423 Ibanate Tablets Artesunate 50mg; Amodiaquine Hcl Usp Equivalent To Amodiaquine 135mg Lupin Laboratories 1st September 22038 H2011/22038/424 Ibanate Tablets Artesunate 100mg; Amodiaquine Hcl Usp Equivalent To Amodiaquine 270mg Lupin Laboratories 1st September 22040 H2011/22040/425 Ibather Tablets Artemether Lumefantrine 20/120mg Lupin Laboratories 1st September 21808 H2011/21808/426 Abacavir Sulphate/Lamivudi ne/ Zidovudine Tablets Abacavir As Sulphate 300mg; Lamivudine Usp 150mg; Zidovudine Usp 300mg Matrix Laboratories 1st September 20691 H2011/20691/428 Osstrim Suspension Trimethoprim B.P 40mg; Sulphamethoxazole Bp 200mg Oss-Chemie (K) Ltd 1st September 19186 H2011/19186/430 Rivaxime Capsules Cefixime 400mg Riva Pharma 1st September 20497 H2011/20497/433 Azal Tablets Azithromycin Dihydrate Usp Equivalent To Azithromycin Anhydrous 500mg Stallion Laboratories Ltd 1st September 21519 H2011/21519/296 Aegesic Tablets Secnidazole 1gm Agio Pharmaceuticals Ltd; India 4th August 2011 21969 H2011/21969/299 Didanosine Capsules Didanosine 400mg As Enteric- Coated Pellets Aurobindo Pharma Ltd 4th August 2011 20867 H2011/20867/300 Vacodil 25 Tablets Carvedilol 25mg Aurobindo Pharma Ltd 4th August 2011 20868 H2011/20868/301 Vacodil 6.25 Tablets Carvedilol 6.25mg Aurobindo Pharma Ltd 4th August 2011 20869 H2011/20869/302 Vacodil 12.5 Tablets Carvedilol 12.5mg Aurobindo Pharma Ltd 4th August 2011 20965 H2011/20965/303 Lopinavir & Ritonavir Tablets Lopinavir 200mg & Ritonavir Usp 50mg Aurobindo Pharma Ltd 4th August 2011 20755 H2011/20755/305 Meftal-P Suspension Mefenamic Acid Bp 100mg Blue Cross 4th August 2011 19560 H2011/19560/312 Erycin Tablets Erythromycin 500mg Flamingo Pharmaceuticals Ltd 4th August 2011 THE KENYA GAZETTE 12th October, 2012 3862 3862 Application No. Registration No. Trade Name Dosage Form Active Ingredients Market Authorisation Holder Date of Registration 8139 H2011/8139/317 Chloraphenirmine Injection Chlorpheniramine Maleate Bp 10mg Harson Laboratories 4th August 2011 8140 H2011/8140/318 Chlorpromazine Injection Chlorpromazine Hcl 25mg Harson Laboratories 4th August 2011 8138 H2011/8138/319 Frusemide Injection Frusemide Bp 10mg Harson Laboratories 4th August 2011 20808 H2011/20808/327 Ornilox Tablets Ornidazole 500mg; Ofloxacin Usp 200mg Micro Labs Limited 4th August 2011 21097 H2011/21097/338 Ovitrelle Injection Choriogonadotrophin Alfa 250 Mcg Serono 4th August 2011 22253 H2011/22253/339 Feveral Injection Paracetamol Bp 300mg; Lidocaine Hcl Bp 20mg Surge Laboratories (Pvt) Ltd 4th August 2011 20148 H2011/20148/343 Db-5 Tablets Medroxyprogestrone Acetate 5mg Unicure Remedies Ltd 4th August 2011 21574 H2011/21574/349 Tazilsun Injection Piperacillin 4g; Tazobactam 500mg Zhuhai Ltd 4th August 2011 22062 H2011/22062/304 Lonart Tablets Artemether 20mg; Lumefantrine 120mg Bliss Gvs Pharma 4th August 2011 21302 H2011/21302/306 Gen-Levo Tablets Levofloxacin 250mg Brookes Pharma 4th August 2011 17558 H2011/17558/311 Lumarterm Dry Suspension Β-ARTEMETHER 15MG; LUMEFANTRINE 90MG Dawa Limited 4th August 2011 22235 H2011/22235/328 Gynosporin Tablets Clotrimazole Usp 500mg Nabiqasm Industries Pvt Ltd 4th August 2011 21930 H2011/21930/333 Therasil Sore Throat (Orange Flavour) Lozenge Amylmetacresol Bp 0.6mg; 2,4 Dichlorobenzyl Alcohol 1.2mg Plethico Pharmaceuticals 4th August 2011 21851 H2011/21851/336 Orcef Tablets 200mg Cefixime As Cefixime Trihydrate Usp Renata Limited 4th August 2011 21861 H2011/21861/337 Orcef Tablets Cefixime Usp 400mg Renata Limited 4th August 2011 21203 H2011/21203/342 Lufenart Suspension Artemether 20mg; Lumefantrine 120mg Umedica Laboratories Ltd 4th August 2011 20382 H2011/20382/345 Viprax Tablets Cefixime Usp As Trihydrate Equivalent To Cefixime 200mg Virchow Helthcare Pvt Ltd 4th August 2011 21264 H2011/21264/346 Heparovit-H Injection Heparin Sodium 5000iu Vital Health Care 4th August 2011 20891 H2011/20891/347 Azith Tablets Azithromycin 500mg Zee Laboratories 4th August 2011 20786 H2011/20786/350 Bupivacaine In Dextrose Injection Bupivacaine Hydrochloride I.P Equivalent To Bupivaciane Hydrochloride 5mg Harson Laboratories 4th August 2011 21468 H2011/21468/351 Netazox-Of Tablets Netazoxanide 500mg; Ofloxacin 200mg Ind Swift Ltd 4th August 2011 21636 H2011/21636/354 Tyde-S Injection Chloramphenicol 1g Neon Laboratories Ltd 4th August 2011 20489 H2011/20489/360 Viprax Dt Tablets Cefixime Trihydrate Usp Equivalent To Anhydrous Cefixime 100mg Virchow Healthcare Ltd; India 4th August 2011 21434 H2011/21434/352 Cilest Tablets Norgestimate 0.25mg; Ethinyl Estradiol 0.035mg Janssen Cilag 4th August 2011 CTD053 H2011/CTD053/356 Menactra Meningococcal Vaccine 4mcg Of Each Polysaccharide Per Sero Group A, C, Y, W-135 Sanofi Pasteur 4th August 2011 CTD190 H2011/CTD190/357 Tanzol Tablets Albendazole Usp 400mg Shalina Laboratories 4th August 2011 20886 H2011/20886/358 Nocuf Breath Easy Capsules Guaifenesin Usp 100mg; Chlorpheniramine Maleate Usp 2mg; Pseudoephedrine Hcl Usp 30mg Softgel Healthcare 4th August 2011 21967 H2011/21967/353 Cilzec Tablets Telmisartan 80mg Mega Life Sciences 4th August 2011 21929 H2011/21929/355 Therasil Sore Throat (Honey- Lemon Flavour) Lonzenges Amylmetacresol B.P 0.6mg; 2, 4 Dichlorobenzyl Alcohol ,1.2 Mg Plethico Pharmaceuticals Ltd 4th August 2011 20006 H2011/20006/359 Asthator Tablets Montelukast 10mg Torrent Pharmaceuticals 4th August 2011 19544 H2011/19544/361 Megaquin Injection Quinine Dihydrochloride Bp 600mg Yanzhou Xier Kangtai Co. 4th August 2011 13643 H2011/13643/367 Elycob-G Cream Clotrimazole Bp 1% W/W; Beclometasone Dipropionate Bp 0.025% W/W; Gentamicin Sulphate Bp 0.215% W/W Elys Chemical Industries Ltd 1st September 22034 H2011/22034/375 Droverine Tablets Drotaverine 40mg Innocia Lifesciences 1st Sept. 2011 21133 H2011/21133/377 Durogesic Transdermal Patch Fentanyl 8.4mg Jansen Cilag 1st Sept. 2011 20845 H2011/20845/381 Leximark Capsules Cefalexin Bp As Monohydrate 250mg Marksans Pharma Ltd 1st September 20846 H2011/20846/382 Leximark Capsules Cefalexin Bp As Monohydrate 500mg Marksans Pharma Ltd 1st September 20850 H2011/20850/384 Cefepimark 1g Injection Cefepime Hcl 1g Marksans Pharma Ltd 1st Sept. 2011 22007 H2011/22007/385 Markaz Tablets Azithromycin Bp 500mg Marksans Pharma Ltd 1st September 21153 H2011/21153/386 Marklevo Tablets Levofloxacin Hemihydrates Equivalent Levofloxacin 500mg Marksans Pharma Ltd 1st September 12th October, 2012 THE KENYA GAZETTE Application No. Registration No. Trade Name Dosage Form Active Ingredients Market Authorisation Holder Date of Registration 19815 H2011/19815/387 Dompan-Od Tablets Domperidone 30mg; Pantoprazole 40mg Medley Pharmaceuticals 1st September 22238 H2011/22238/389 Stir Up Tablets Memantine Hcl 10mg Nabiqasm Industries Pvt Ltd 1st September 21238 H2011/21238/391 Falquin Injection Quinine Dihydrochloride 600mg Plethico Pharmaceuticals 1st September 20007 H2011/20007/397 Asthator Tablets Montelukast 5mg Torrent Pharmaceuticals 1st September 20005 H2011/20005/398 Asthator Tablets Montelukast 4mg Torrent Pharmaceuticals 1st September 21566 H2011/21566/399 Clotrine Pessaries Clotrimazole Usp 500mg Universal Corporation 1st September 22127 H2011/22127/400 Clotrine Dusting Powder Clotrimazole B.P 1% W/W Universal Corporation 1st September 21116 H2011/21116/436 Valtas Od Tablets Divalproex Sodium Usp Equivalent To Valproic Acid Usp Intas Pharmaceuticals Ltd 1st September 21683 H2011/21683/437 Nebtas Tablets Nebivolol Hydrochloride Equivalent To Nebivolol 5mg Intas Pharmaceuticals Ltd 1st September CTD218 H2011/CTD218/440 Ventomol Syrup Salbutamol B.P 2mg (As Sulphate) Skylight Chemicals Ltd 1st September CTD301 H2011/CTD301/441 Histarex Solution Cetirizine Dihydrochloride 1mg Skylight Chemicals Ltd 1st September 20057 H2011/20057/443 Ridmal Tablets Dihydroartemisinin Ph. Int. 40mg; Piperaquine Phosphate 320mg Ajanta Pharma 1st September 22145 H2011/22145/444 Acdermin Gel Clindamycin Usp 1.2% W/W; Tretinoin Usp 0.025% W/W (Atco Specifications) Atco Laboratories Ltd 1st September CTD217 H2011/CTD217/445 Omis Capsules Omeprazole Bp 20mg (As Enteric Coated Granules) Augment Remedies 1st September 17254 H2011/17254/446 Lamivudine Oral Solution Lamivudineusp 10mg Aurobindo Pharma Limited 1st September 21816 H2011/21816/447 Bexitrol-F Hfa Inhaler Salmeterol Xinafoate Bp Eq. To 25mcg Salmeterol Fluticasone Propionate Bp 50mcg Beximco Pharmaceuticals Ltd 1st September 21819 H2011/21819/448 Bexitrol-F Hfa Inhaler Salmeterol Xinafoate Bp Eq. To 25mcg Salmeterol Beximco Pharmaceuticals Ltd 1st September 22194 H2011/22194/449 Leeflox Tablets Levofloxacin Hemihydrates Eq. To Levofloxacin 500mg Centaur Pharmaceuticals Ltd 1st September CTD076 H2011/CTD076/450 Viraday Tablets Tenofovir Disoproxil Fumarate 300mg Eq To Tenofovir Disoproxil 245mg; Emtricitabine 200mg; Efavirenz 600mg Cipla Ltd 1st September CTD075 H2011/CTD075/451 Tenvir-Em Tablets Tenofovir Disoproxil Fumarate 300mg Eq To Tenofovir Disoproxil 245mg; Emtricitabine 200mg Cipla Ltd 1st September CTD043 H2011/CTD043/452 Duomune Tablets Lamivudine 300mg; Tenofovir Disoproxil Fumarate 300mg Eq To Tenofovir Disoproxil 245mg Cipla Ltd 1st September 19994 H2011/19994/453 Moxaforte Capsules Flucloxacillin As Sodium Bp 250mg And Amoxicillin As Trihydrate Bp 250mg Dawa Limited 1st September 21396 H2011/21396/454 Dawaclox Powder For Oral Solution Oral Solution Cloxacillin Sodium Bp Equivalent To Cloxacillin 125mg Dawa Limited 1st September CTD320 H2011/CTD320/455 Paracetamol Tablets Paracetamol 500mg Elys Chemical Industries Ltd 1st September 17611 H2011/17611/456 Vinelbine 10mg/1ml I.V Injection Vinorelbine Tartrate Usp Eq. To Vinorelbine 10mg Fresenius Kabi Oncology Ltd 1st September 22252 H2011/22252/457 Metoclon Injection Metoclopramide Hcl 10mg Indus Harma 1st September CTD130 H2011/CTD130/458 Cadronate Tablets Ibandronic Acid Monosodium Monohydrate 177mg Meyer Organics Pvt Ltd 1st September 16225 H2011/16225/460 Enril Tablets Enalapril Maleate Usp 5mg Prism Life Sciences 1st September CTD020 H2011/CTD020/461 Xolide Capsules Azithromycin Dehydrate Usp Eq. To Azithromycin 500mg Radiant Pharmaceuticals Limited 1st September 21743 H2011/21743/462 Tamoplus Tablets Paracetamol Bp 500mg Shanxi Guangsheng Pharmaceuticals Co. Ltd 1st September CTD151 H2011/CTD151/463 Shraco Capsules Itraconazole 100mg Sharon Bio-Medicine 1st Sept. 2011 CTD152 H2011/CTD152/464 Ulemac Capsules Esomeprazole 20mg Sharon Bio-Medicine 1st September CTD201 H2011/CTD201/465 Thromiz Tablets Azithromycin 500mg Sharon Bio-Medicine 1st Sept. 2011 THE KENYA GAZETTE 12th October, 2012 3864 3864 Application No. Registration No. Trade Name Dosage Form Active Ingredients Market Authorisation Holder Date of Registration 21334 H2011/21334/466 Maxicare Injection Meropenem Usp Eq. To Anhydrous Meropenem 1g Vhb Medi Science Limited 1st September 21740 H2011/21740/402 Threomycin Tablets Azithromycin Dehydrate Usp Equivalent To Azithromycin Base 500mg Augment Remedies 6th October 2011 21760 H2011/21760/411 Lofnac Mr Tablets Diclofenac Sodium Bp 50mg; Paracetamol Bp 325mg; Chlorzoxazone Usp 250mg Bliss Gvs Pharma Ltd 6th October 2011 18985 H2011/18985/414 Dawastin Suspension Nystatin Bp 100,000i.U Dawa Ltd; Kenya 6th October 2011 21753 H2011/21753/415 Streptomycin Injection Streptomycin Base 1g Dawa Ltd; Kenya 6th October 2011 20856 H2011/20856/416 Bpmet-Xl Tablets Metoprolol Tartrate 12.5mg Emcure Pharmaceuticals Ltd 6th October 2011 21950 H2011/21950/421 Cardpz Tablets Carvedilol Ep 6.25mg Ipca Laboratories Ltd 6th October 2011 22096 H2011/22096/429 Poldan Mig Caplets Acetaminophen 400mg; Caffeine 65mg; Aspirin 262.5mg Pt Sanbe Farma 6th October 2011 CTD297 H2011/CTD297/431 Sharome Capsules Omeprazole 20mg Sharon Bio-Medicine 6th October 2011 CTD306 H2011/CTD306/432 Paragest Tablets Paracetamol 500mg Sharon Bio-Medicine 6th October 2011 CTD291 H2011/CTD291/434 Repalol Tablets Losartan Potassium 50mg; Atenolol 50mg Sun Pharmaceuticals Ltd 6th October 2011 20659 H2011/20659/435 Ifen Oral Suspension Ibuprofen Bp 200mg Zest Pharma 6th October 2011 17681 V2011/17681/010 Bilivin Injection Ivermectin Bp 10mg Brilliant Industries 6th October 2011 V2011//011 Tylosip Powder Tylosin Tartrate Bp 2g Cipla 6th October 2011 15045 V2011/15045/012 Prazivet Plus Tablets Praziquantel Usp 50mg; Pyrantel Pamoate Usp 144mg; Febantel 150mg Cipla Vet-Care 6th October 2011 21530 V2011/21530/016 Levamix Suspension Levamisole 1.5% W/V Skylight Chemicals Ltd 6th October 2011 20949 V2011/20949/017 Mastiwok Intramammary Suspension Cefoperazone Sodium Usp Equivalent To Cefoperazone 250mg Vetoquinol India Animal Pvt 6th October 2011 21818 H2011/21818/467 Bexitrol Hfa Inhaler Salmeterol Xinafoate Bp Equivalent To 25mcg Salmeterol; Fluticasone Propionate Bp 250mcg Beximco Pharmaceuticals 1st December 21817 H2011/21817/468 Bexitrol Hfa Inhaler Salmeterol Xinafoate Bp Equivalent To 25mcg Salmeterol; Fluticasone Propionate Bp125mcg Beximco Pharmaceuticals 1st December 22242 H2011/22242/469 Amdocal Plus Tabelts Amlodipine Besilate Equivalent To Amlodipine 5mg; Atenolol 50mg Beximco Pharmaceuticals 1st December 22243 H2011/22243/470 Odrel Plus Tabelts Clopidogrel Bisulfate Inn 75mg; Aspirin Usp 75mg Beximco Pharmaceuticals 1st Dec. 2011 22164 H2011/22164/471 Napa Extra Tabelts Paracetamol Bp 500mg; Caffeine Bp 65mg Beximco Pharmaceuticals 1st Dec. 2011 CTD247 H2011/CTD247/472 Carbosten 5% Syrup Carbocisteine 250mg Dawa Limited 1st Dec. 2011 CTD082 H2011/CTD082/473 Rosucrest Tabelts Rosuvastatin 10mg Glaxosmithkline Ltd 1st Dec. 2011 CTD083 H2011/CTD083/474 Rosucrest Tabelts Rosuvastatin 20mg Glaxosmithkline Ltd 1st Dec. 2011 CTD312 H2011/CTD312/475 Rhinahist Chesty Syrup Carbocisteine 5g Skylight Chemicals Ltd 1st Dec. 2011 CTD311 H2011/CTD311/476 Rhinahist Syrup Carbocisteine 2g Skylight Chemicals Ltd 1st Dec. 2011 22265 V2011/22265/013 Ivermectin Injection Ivermectin 1% W/V Metrovet (K) Ltd 14th July 2011 22289 H2011/22289/459 Galaxy Naygra Capsules Withania Somnifera (Ashwagandha) 120mg; Asparagus Adscendens (Safed Musali) 120mg; Mucuna Pruriens (Kaunch Beej) 80mg; Tribulus Terrestris (Gokharu) 70mg; Asphaltum (Shilajit) 50mg; Asparagus Racemosus (Shatavari) 50mg; Anacyclus Pyrethrum (Akkalkara) 50mg; Piper Longum (Pippalimula) 10mg Meyer Organics Pvt Ltd 1st Dec. 2011 21442 H2011/21442/390 Exforge Hct Tablets Amlodipine 10mg; Valsartan 160mg; Hydrochlorothiazide 25g Novartis Pharma Stein Ag 1st September 20929 H2011/20929/438 C-Mark Tablets Cefixime Usp 200mg Marksans Pharma Ltd 1st Sept. 2011 20849 H2011/20849/439 Ciprocin Tablets Ciprofloxacin Hcl 500mg Marksans Pharma Ltd 1st Sept. 2011 22111 V2011/22111/018 Albendex 300 Bolus Albendazole Usp 300mg Vet Care Kenya Limited 1st Sept. 2011 22110 V2011/22110/019 Albendex 600 Bolus Albendazole Usp 600mg Vet Care Kenya Limited 1st Sept. 2011 22112 V2011/22112/020 Albendex 2500 Bolus Albendazole 2500mg Vet Care Kenya Limited 1st Sept. 2011 17840 V2011/17840/021 Bizole 10% Suspension Albendazole Usp 500mg/5ml Brilliant Industries 4th August 2011 Dated the 27th August, 2012. KIPKERICH C. KOSKEI, Registrar. 12th October, 2012 THE KENYA GAZETTE