ZAMBIA MEDICINES REGULATORY AUTHORITY REGISTER OF MARKETING AUTHORISATIONS

Transcription

1 S/No Product Name Generic Name Category of Distribution Dosage Form Marketing Authorisation Number Marketing Authorisation Holder 1 Poulvac SE Salmonella enteritidis bacterin Solution for Injection 007/701V Zoetis South Africa (Pty) Ltd 2 MG Bac Mycoplasma gallisepticum, inactivated bacterin Solution for Injection 007/703V Zoetis South Africa (Pty) Ltd Poulvac Bursine 2 Lyophilisate for 3 Infectious bursal disease virus strain Lukert >104.3TCID50 suspension for drinking water 007/704V Zoetis South Africa (Pty) Ltd Poulvac ST Lyophilisate for spraying 4 Salmonella typhimurium Vaccine, Live Culture and for suspension for drinking water 007/706V Zoetis South Africa (Pty) Ltd Poulvac SE/ND/IB Salmonella 5 enteritidis Bacterin Newcastle- Bronchitis Vaccin Solution for Injection 007/707V Zoetis South Africa (Pty) Ltd Poulvac Ovoline CVI+HVT 6 Marek's Disease Chicken Herpes virus + Marek's DiseaseTurkey Herpes virus Solution for Injection 007/708V Zoetis South Africa (Pty) Ltd Poulvac New LaSota Newcastle Disease Virus, LaSota strain Solution for oral 7 Not Less Than 1 X 106 EID50) administration 007/710V Zoetis South Africa (Pty) Ltd Poulvac Pabac IV Killed Pasteurella multocidax-73 8 (serotype 1*), P-1059 (serotype 3*), P (serotype 4*), CU (serovar 3x4*) Solution for Injection 007/711V Zoetis South Africa (Pty) Ltd Poulvac Pox AE Avian Encephalomyelitis-Fowl Pox 9 Vaccine Solution for Injection 007/712V Zoetis South Africa (Pty) Ltd 10 Poulvac Pox Live fowl pox virus Solution for Injection 038/705V Zoetis South Africa (Pty) Ltd Poulvac NCD Lyophilisate for 11 Newcastle Disease Virus, LaSota strain Not Less Than 1 X 106 EID50) suspension for drinking water 038/713V Zoetis South Africa (Pty) Ltd 12 Poulvac Bursa F Live infectious Bursal disease virus (V877) MEDICINES FOR VETERINARY USE 13 Poulvac E coli Escheria Coli Bacterin Lyophilisate for suspension for drinking water 038/714V Zoetis South Africa (Pty) Ltd Lyophilisate for Suspension for Spray Vaccination and Oral Administration 038/715V Zoetis South Africa (Pty) Ltd Page 1 of 40

2 14 Poulvac 6 vaccine Newcastle disease (La Sota strain) 1- inactivated viral fluid Solution for oral administration 038/716V Zoetis South Africa (Pty) Ltd 15 Poulvac IC ABC oil - Infectous Coryza Bacterin 221 strain (Serovar A)- inactivated bacterial concentrate Emulsion for Injection 038/717V Zoetis South Africa (Pty) Ltd 16 Calfoset Injection Calcium Gluconate 44g, per 100ml Solution for Injection 055/701V Kenya 17 Bupalex Injection Bupavarquone, 50mg Solution for Injection 055/702V Kenya 18 Pet D Worm Tablets Mebendazole BP, 110 mg + Piperazine BP, 275mg + Praziquantel BP, 25 mg P-V Tablet Enteric Coated 055/703V Dawa Phamaceuticals Limited, Kenya 19 Fasoverm DS Oxyclozanide, 6% + Levamisole HCl, 3% + Cobalt Sulphate, 0.764% P-V Suspension for Oral Use 055/704V Dawa Phamaceuticals Limited, Kenya Trimethoprim, 2% + Dawa Phamaceuticals Limited, 20 Trimoxol - Vet Oral Powder Sulphamethoxazole, 10% P-V Powder for Oral Solution 055/705V Kenya Powder for Oral Dawa Phamaceuticals Limited, 21 Dascarnil Worm Powder Piperazine, 0.35mg P-V Suspension 055/706V Kenya 22 Damectin Injection Ivermectin 10mg per ml Solution for Injection 055/707V Kenya 23 Dexajet Injection Sodium Dexamethasone Sodium Phosphate, 2mg Solution for Injection 055/708V Dawa Phamaceuticals Limited, Kenya 24 Dabendazole Albendazole 2500mg per bolus P-V Bolus 055/709V Kenya 25 Enrox 10% Injection Enrofloxacin 10% w/v Solution for Injection 055/710V Kenya 26 Egocin 20% Solution Oxytetracycline HCL 200mg Solution for injection 055/711V Kenya 27 Dawasole 1.5% Oral Solution Levamisole Hydrochloride 15mg P-V Use 055/712V Dawa Phamaceuticals Limited, Kenya 28 Dabendazole 10% Suspension Albendazole 10%w/v P-V Suspension for Oral Use 055/713V Dawa Phamaceuticals Limited, Kenya 29 Butasal -100 Injection Butafosfan-10% Solution for Injection 057/230V BV, Holland 30 Intracox Oral Toltrazuril 25mg per ml P-V Use 057/231V BV, Holland 31 Albenol Bolus Albendazole 2500mg per bolus P-V Bolus 057/232V BV, Holland 32 Tryponil Granules Diminazene aceturate 44mg per g Granules for Solution 057/233V BV, Holland 33 Colexin pump solution Colistin, IU + Trimethoprim 50.0mg per ml Use 057/701V Interchemie Werkende Adelaar, BV, Holland 34 Glucort-20 injection Dexamethasone 2.0mg per ml Solution for Injection 057/702V BV, Holland 35 Introvit WS powder Minerals + Multivitamin + Amino acids GS Powder for Oral Solution 057/703V BV, Holland 36 Intrafer-100 injection Iron + Vitamin B 12 Solution for Injection 057/704V BV, Holland 37 Sulfadimidin WS powder Sulfadimidine 1000mg per g Powder for Oral Solution 057/705V BV, Holland 38 Limoxin-200LA injection Oxytetracycline 200mg per ml Solution for Injection 057/706V BV, Holland 39 Limoxin-100 injection Oxytetracycline 100mg per ml Solution for Injection 057/707V BV, Holland 40 Intermectin injection Ivermectin 10mg per ml Solution for Injection 057/708V BV, Holland Page 2 of 40

3 41 Amprolin-300 WS Amprolium HCl 300mg per g Powder for oral administration 057/709V Interchemie Werkende Adelaar, BV, Holland 42 Biocillin LA, 100ml Amoxicillin Trihydrate 150mg per ml Suspension for Injection 057/710V BV, Holland 43 Genta-100, 100 ml injection Gentamicin Sulphate 100mg per ml Solution for Injection 057/711V Interchemie Werkende Adelaar, BV, Holland 44 Gentadox WS powder Doxycycline Hyclate 100mg + Gentamicin sulphate 50mg per g Powder for Feed 057/712V Interchemie Werkende Adelaar, BV, Holland 45 Intertrim LA, 100 ml Sulfadoxine 200mg + Trimethoprim 40mg per ml Solution for Injection 057/713V Interchemie Werkende Adelaar, BV, Holland 46 Introvit - C WS Powder Vitamin C (ascorbic acid) 1000mg per g GS Powder for Oral administration 057/714V Interchemie Werkende Adelaar, BV, Holland 47 Introvit - ES WS powder Sodium Selenite 200mg + Vitamin+ E 2mg per g GS Powder for Oral administration 057/715V Interchemie Werkende Adelaar, BV, Holland 48 Ketosol injection Ketoprofen 100mg per ml Solution for Injection 057/716V BV, Holland 49 Oxytocin - 20 injection 50 ml Oxytocin 20 IU per ml Solution for Injection 057/717V Interchemie Werkende Adelaar, BV, Holland 50 Amprocox WS powder Amprolium Hydrochloride 200mg + Sulfaquinoxaline 150mg per g Powder for Oral administration 057/718V Interchemie Werkende Adelaar, BV, Holland 51 Interflox injection Enrofloxacin 100mg per ml Solution for Injection 057/719V BV, Holland 52 Intertrim WS Powder Sulfadiazine 400mg + Trimethoprim + 80 mg per g Powder for Oral administration 057/720V Interchemie Werkende Adelaar, BV, Holland 53 Introvit A + WS Powder Retinol -acetate powder, 20n000 IU + Cholecalciferol powder 6,000 IU per g Powder for oral administration 057/721V Retinol Palmitate IU + Cholecalciferol 500 IU +Tocopherol 54 Introvit Injection Acetate 10.0 mg per ml Solution for Injection 057/722V 55 Macrolan Injection Tylosin base 200mg per ml Solution for Injection 057/723V BV, Holland Retinol acetate powder, Cholecalciferol powder (vitamin D3) + Powder for oral 56 Sressmix WS Powder multivitamins administration 057/724V BV, Holland Interchemie Werkende Adelaar, BV, Holland Interchemie Werkende Adelaar, BV, Holland Interchemie Werkende Adelaar, 57 Introcil Pump Colistin Sulphate IU + Spectinomycin 50mg per ml Solution for Injection 057/725V Interchemie Werkende Adelaar, BV, Holland 58 Dimoxan WS Powder Amoxicillin base 200mg + Colistin (as sulphate) 1200 mg per g Powder for Oral Solution 057/726V Interchemie Werkende Adelaar, BV, Holland 59 Limoxin- WS Powder Oxytetracycline HCl 100mg per g Powder for Oral Solution 057/727V BV, Holland 60 Limoxin - 25 Spray Oxytetracycline HCl 25mg per g Spray for Topical Use 057/728V BV, Holland 61 Biogenta Injection Amoxicillin Trihydrate 150mg + Gentamicin base, 40 mg per ml Solution for Injection 057/729V Interchemie Werkende Adelaar, BV, Holland Page 3 of 40

4 62 Piperin WS Powder Piperazine 1000mg per g P-V Powder for Oral Solution 057/730V BV, Holland 63 Sulfacox ws powder Sulfadimidine sodium 200mg + sulfaquinoxaline 25mg + pyremthamine 25mg per g Powder for Oral Solution 057/731V Interchemie Werkende Adelaar, BV, Holland Whey protein concentrate, 325mg, + Alanine mg + Aspartic acid, 24.74mg + Cysteine, 5.3mg + Glutamic acid, 42.68mg + Glycine, 4.95mg + Histidine, 5.43mg + Isoleucine, 14.45mg + Lysine, 20.56mg + Methionine, 3.98 mg + Phenylalanine, 6.40mg + Proline, 13mg + Serine, 13.19mg + Threonine, 16.30mg + Tryptophan, 4.07mg + Tyrosine, 5.14mg + Valine 13.77mg per ml GS Powder for Oral Solution 057/732V Interchemie Werkende Adelaar, BV, Holland 64 Aminogrow ws 65 Butachem - 50 injection Buparvaquone 50mg Solution for Injection 057/733V BV, Holland 66 Intracox pump Toltrazuril 25mg per ml Use 057/734V BV, Holland 67 Alvenax 2500 bolus Albendazole 2500mg per bolus P-V Tablet Uncoated 122/701V Star Laboratories Pvt Ltd, Pakistan 68 Rasomycin L.A injection Oxytetracycline 200mg per ml Solution for Injection 122/702V Star Laboratories Pvt Ltd, Pakistan 69 Biquin injection Quinapyramine sulphate 1500mg + Quinapyramine chloride 1000mg per ml Solution for Injection 122/703V Star Laboratories Pvt Ltd, Pakistan 70 Ivotek injection Ivermectine 10mg per ml Solution for Injection 122/704V Star Laboratories Pvt Ltd, Pakistan 71 Avitone powder 100gm Minerals + Vitamins P-V Powder for Oral Solution 122/705V Star Laboratories Pvt Ltd, Pakistan 72 Coxifin powder Amprolium + Furaltadone + Vitamin A + Vitamin D3 + Vitamin K Powder for feed 122/706V Star Laboratories Pvt Ltd, Pakistan 73 Diarroban powder 12gm Neomycin 400mg + Strptomycin 400mg + Vitamin A + Kaolin + Pectin + Bismuth Powder for Oral Solution 122/707V Star Laboratories Pvt Ltd, Pakistan 74 STR 600 powder 100 gm Minerals + Vitamins P-V Powder for Oral Solution 122/708V Star Laboratories Pvt Ltd, Pakistan 75 Tylovital F powder Tylosin + Erythromycin + Furaltadone 1000g Powder for Oral Solution 122/709V Star Laboratories Pvt Ltd, Pakistan 76 Bupralex injection Buparvaquone 50mg per ml Solution for Injection 122/710V Star Laboratories Pvt Ltd, Pakistan 77 Almox 15% - LA injection Amoxicillin Trihydrate 150 mg per ml Solution for Injection 122/715V Star Laboratories Pvt Ltd, Pakistan 78 Butadin injection Phenylbutazone 20mg per ml Solution for Injection 122/716V Star Laboratories Pvt Ltd, Pakistan 79 Dexavet injection Dexamethasone Sodium Phosphate Base 1mg per ml Solution for Injection 122/717V Star Laboratories Pvt Ltd, Pakistan 80 Imicarb injection Imidocarb propionate 120mg per ml Solution for Injection 122/718V Star Laboratories Pvt Ltd, Pakistan Page 4 of 40

5 81 Milfone-C injection ZAMBIA MEDICINES REGULATORY AUTHORITY Calcium Gluconate gm + Magnesium Hypophosphite 5.33 gm + Magnesium chloride 2.00 gm gm Solution for Injection 122/719V Star Laboratories Pvt Ltd, Pakistan 82 Nutramin powder Calcium 15.4% + Phosphorous 13.5% + Sodium 5.5% + Magnesium 4.5% + Iron 1000mcg + Zinc 3000mcg + Manganese 2000 P-V Powder for feed 122/720V Star Laboratories Pvt Ltd, Pakistan 83 Pencin-LA injection Benzanthine Penicillin G IU + Procaine Penicillin G Dihydros 200mg per ml Solution for Injection 122/721V Star Laboratories Pvt Ltd, Pakistan 84 Thunder drench Triclabendazole 12 gm + Ivermectin 0.2 gm + Albendazole 10 gm P-V Suspension 122/722V Star Laboratories Pvt Ltd, Pakistan 85 Vitaden injection Vitamin A (Palmitate) IU + Vitamin D3 (Cholecalferol) IU + Vitam 50mg GS Solution for Injection 122/723V Star Laboratories Pvt Ltd, Pakistan 86 Levozan bolus Levamisole HCl 1125 mg + Oxyclozanide 2250 mg per ml P-V Bolus 122/724V Star Laboratories Pvt Ltd, Pakistan 87 Bayopet Bacdip Plus Flumethrin 2 % m/v + piperonyl butoxide10 % m/v Solution for Topical Use 140/701V Bayer (Pty) Limited, South Africa 88 Baytril 5 % Injection Enrofloxacin 50 mg per ml Solution for Injection 140/702V Bayer (Pty) Limited, South Africa 89 Blitzdip Pour-on for Cattle Cypermethrin 1 % m/v GS Solution for Topical Use 140/703V Bayer (Pty) Limited, South Africa 90 Catosal 10 % Injection Butaphosphan 10g + vitamin B12 + cyanocobalamin 5 mg per ml Solution for injection 140/704V Bayer (Pty) Limited, South Africa 91 Cylence Pour-On Solution Cyfluthrin 1 % m/v GS Solution for Topical Use 140/705V Bayer (Pty) Limited, South Africa 92 Drastic Deadline Pour-on solution Flumethrin 1 % m/v GS Solution for Topical Use 140/706V Bayer (Pty) Limited, South Africa 93 Deadline Extreme Pouron. Fluazuron 2.5 % m/v + Flumethrin 1.0 % m/v GS Solution for Topical Use 140/707V Bayer (Pty) Limited, South Africa 94 Hi-Tet Aerosol Oxytetracycline HCl 40 mg per g Solution for Topical Use 140/708V Bayer (Pty) Limited, South Africa 95 Kalftabs NF Tablets Sulphathiazole 4.5 g per tablet Tablet Uncoated 140/709V Bayer (Pty) Limited, South Africa 96 Karbadip Spray powder Carbaryl 50 % m/m POM Powder for Solution for Topical Use 140/710V Bayer (Pty) Limited, South Africa 97 Animalax Gel White Petrolatum B.P 2 G + Lecithin 250 Mg + Cod Liver Oil 65 Mg + Linseed Raw Oil BP 3 Mg + Vitamin B1 0.2mg + Vitamin A 500 IU + Vitamin B6 + Vitamin B2 0.1mg + Vitamin B Μg per 5grams GS Gel for Oral Use 140/711V Bayer (Pty) Limited, South Africa Page 5 of 40

6 98 Atropine 0.5 Injection Atropine 0.5 mg per 10ml Solution for Injection 140/712V Bayer (Pty) Limited, South Africa 99 Atropine 10 Injection Atropine 10 mg per 10ml Solution for Injection 140/713V Bayer (Pty) Limited, South Africa 100 Baycox 5 % Liquid Toltrazuril 2.5 mg/ml m/v P-V Administration 140/714V Bayer (Pty) Limited, South Africa 101 Bayopet Tick and Flea Cat Collar Propoxur 9.4 % m/m GS Powder for Topical Administration 140/715V Bayer (Pty) Limited, South Africa 102 Baycox 2.5 % Liquid Toltrazuril 2.5 mg/ml m/v P-V Administration 140/716V Bayer (Pty) Limited, South Africa 103 Bayopet Tick and Flea Dog Collar for Medium/ Large Dogs Propoxur 9.4 % m/m GS Powder for Topical Administration 140/717V Bayer (Pty) Limited, South Africa 104 Bayopet Tick and Flea Powder Propoxur 1 % m/m GS Powder for Topical Administration 140/718V Bayer (Pty) Limited, South Africa 105 Bayopet Tick and Flea Collar for Small Dogs Propoxur 9.4 % m/m GS Powder for Topical Administration 140/719V Bayer (Pty) Limited, South Africa 106 Bayopet Wormol Liquid Piperazine citrate (neutral salt) 12.5 % P-V Administration 140/720V Bayer (Pty) Limited, South Africa 107 Beefee Tabs Protein 600 mg + Vitamin A 1800 IU + Thiamine 2 Mg + Riboflavine 1.5 Mg + Pyridoxine 0.3 Mg + Vitamin B Mcg + Vitamin D3 250 IU + Vitamin E 2 IU + Folic Acid 50 Mcg + Niacin 10 Mg + Calcium 75 M +, Phosphorus 55 Mg + Copper 50 Mcg + Manganese 2 Mg + Cobalt 20 Mcg + Iron 1 Mg + Zinc 2 Mg GS Tablets for Oral Use 140/721V Bayer (Pty) Limited, South Africa 108 Bos-B-Nut Powder Polyethylene glycol 900 g + Cobalt 150 mg + Iodine 750 mg per kg GS Powder for Oral Administration 140/722V Bayer (Pty) Limited, South Africa 109 Brutel Suspension Praziquantel 3.75 % w/v. P-V Suspension for Oral Administration 140/723V Bayer (Pty) Limited, South Africa 110 Doxymycin Eye Powder Doxycycline 1 % m/m + sulphacetamide sodium 5 % m/m + cetrimide 1 % m/m Powder for Topical Administration 140/724V Bayer (Pty) Limited, South Africa Page 6 of 40

7 111 Beefee Powder 250g 112 Calsup Powder Vitamin A IU + Vitamin D 15 IU + Vitamin E 0.75 IU + Vitamin C 12.5 mg + thiamine 0.25 mg+ riboflavin 0.5 mg + pyridoxine 0.05 mg + vitamin B12 1 mcg + biotin 0.15 mg + niacin 1.5 mg + pantothenic acid 0.5 mg + folic acid 15 mcg + inositol 50 mcg + lysine 0.5 mg + glycine 0.5 mg + choline bi tartrate 10 mg + dl-methionine 0.5 mg + calcium 0.49 g + phosphorus 0.38 g + magnesium 2.0 mg + iron 2.75 mg + copper 0.3 mg + manganese 0.35 mg + zinc 0.2 mg + iodine 0.15 mg + cobalt 30 mcg + sodium chloride 50 mg Calcium, 367 mg + phosphorus, 162 mg (*from calcium gluconate, calcium phosphate dibasic, calcium lactate and calcium glycerophosphate) + Vitamin A IU + Vitamin D 200 IU + Vitamin E 2 IU + iron (as ferrous fumarate) 16 mg peer 5g GS GS Powder for Oral Administration 140/725V Bayer (Pty) Limited, South Africa powder for Oral Administration 140/726V Bayer (Pty) Limited, South Africa 113 Drontal Flavoured for Medium Dogs Tablets Praziquantel 50 mg + febantel 150 mg + Pyrantel embonate 144 mg per ml P-V Tablets for Oral use 140/727V Bayer (Pty) Limited, South Africa 114 Endotape Oral drench. Levamisole HCl 37.5 mg + Praziquantel 18.8 mg per ml P-V Administration 140/728V Bayer (Pty) Limited, South Africa 115 Eutha-naze Injectable solution. Sodium Pentobarbitone 200mg per ml Solution for Injection 140/729V Bayer (Pty) Limited, South Africa 116 Hi-Tet 120 Injectable solution. Oxytetracycline hydrochloride 120 mg per ml Solution for Injection 140/730V Bayer (Pty) Limited, South Africa 117 Legend Injection Sodium hyaluronate 10 mg per ml Solution for Injection 140/731V Bayer (Pty) Limited, South Africa 118 Levicon Liquid Levamisole hydrochloride 25 % m/v P-V Administration 140/732V Bayer (Pty) Limited, South Africa 119 Levisan Liquid. Levamisole hydrochloride 2.5 % m/v + Oxyclozanide3,4 % m/v. P-V Administration 140/733V Bayer (Pty) Limited, South Africa 120 Doxymycin QA injection Doxycycline hyclate 100 mg per ml Solution for Injection 140/734V Bayer (Pty) Limited, South Africa Page 7 of 40

8 121 Bayopet Blue Liquid 122 Wound Aerosol NF ZAMBIA MEDICINES REGULATORY AUTHORITY Vitamin B mg + vitamin B1 10 mg + vitamin B2 20 mg + vitamin B6 10 mg + calcium D-pantothenate 20 mg + nicotinamide 100 mg + ferric ammonium citrate 1 g + calcium glycerophosphate 1 g per 100ml GS Dichlorophen 1.0 % m/v + Propetamphos 0.25 % m/v + Pine oil 2.5 % v/v P-V 123 Advantage for cats Imidacloprid 10 % m/v P-V Administration 140/735V Bayer (Pty) Limited, South Africa Solution for Topical Administration 140/736V Bayer (Pty) Limited, South Africa Solution for Topical Administration 140/737V Bayer (Pty) Limited, South Africa Solution for Topical Administration 140/738V Bayer (Pty) Limited, South Africa Solution for Topical Administration 140/739V Bayer (Pty) Limited, South Africa Solution for Topical Administration 140/740V Bayer (Pty) Limited, South Africa Solution for Topical Administration 140/741V Bayer (Pty) Limited, South Africa 124 Advantage For Dogs Imidacloprid 10 % m/v P-V Imidacloprid 10 % m/v + Permethrin Advantix for Dogs % m/v P-V Imidacloprid 10% m/v + Moxidectin 1% 126 Advocate for Cats m/v. P-V Imidacloprid 10% m/v + Moxidectin 127 Advocate for Dogs 2.5% m/v P-V 128 Lignocaine 2 % Injection lignocaine hydrochloride 20mg per ml Solution for Injection 140/742V Bayer (Pty) Limited, South Africa 129 Lintex Liquid Niclosamide 20 % m/v. P-V Use 140/743V Bayer (Pty) Limited, South Africa 130 Mastest Liquid Texapon K12G, g per 5L GS Test Solution 140/744V Bayer (Pty) Limited, South Africa 131 Milbitraz Spray Dip Amitraz 125 g per L. GS Solution for Topical Administration 140/745V Bayer (Pty) Limited, South Africa 132 Necrospray NF 200G Oxytetracycline hydrochloride 4 mg per 200g Solution for Topical Use 140/746V Bayer (Pty) Limited, South Africa 133 Phenylarthrite Injection Phenylbutazone 200 mg per ml Solution for Injection 140/747V Bayer (Pty) Limited, South Africa 134 Phosamine Injection 135 PPR Powder Pyridoxine Hydrochloride 92mg (including an 84 % excess) + Cyanocobalamin (Vitamin B6) 12.6mg (includes a 5% excess) + Sodium Glycerophosphate 210 mg includes a 5% excess per ml GS Solution for Injection 140/748V Bayer (Pty) Limited, South Africa Kaolin (light) 48% + Sodium thiosulphate 12% + Charcoal (activated) 40 % GS Powder for Oral Solution 140/749V Bayer (Pty) Limited, South Africa Page 8 of 40

9 Nitrofurazone 250mg + Prednisolone 250mg + Neomycin(as sulphate) 136 Prenine Ointment 500mg) per 100g P-V Ointment for Topical Use 140/750V Bayer (Pty) Limited, South Africa 137 Procapen LA Injection Benzathiane penicillin 112.5mg + Procaine penicillin 150mg per ml Solution for Injection 140/751V Bayer (Pty) Limited, South Africa 138 Profender Spot On Emodepside 21.4 mg + Praziquantel 85.8 mg per ml P-V Solution for Topical Use 140/752V Bayer (Pty) Limited, South Africa 139 Ripercol-L Soluble Powder Levamisole hydrochloride % m/m P-V Powder for Oral administration 140/753V Bayer (Pty) Limited, South Africa 140 Rompun 2% Injection Xylazine hydrochloride 200mg per ml Solution for Injection 140/754V Bayer (Pty) Limited, South Africa 141 Secta Insecticidal Shampoo 142 Stoplaks Powder 143 Sulfazine 33.13% Injection 144 Tick & Maggot Oil Plus Cypermethrin 720 mg + Piperonyl butoxide mg + lanolin + special oils and conditioners 50 g per L Each 100 g sachet contains Glucose % m/m + Sulphaguanidine 1.50 % m/m + Sulphadiazine 1.50 % m/m + Phthalylsulphathiazole 1.50 % m/m + Vitamin A acetate IU/g (0.012 % m/m) + Electrolytes % m/m Sulphadimidine sodium BP 33 1/3 % GS Solution for Topical Use 140/755V Bayer (Pty) Limited, South Africa Powder for Oral adminstration 140/756V Bayer (Pty) Limited, South Africa m/v Solution for Injection 140/757V Bayer (Pty) Limited, South Africa Chlorfenvinphos 1 % m/v + cypermethrin 0.1 % m/v + Pine oil Solution for Topical 4%m/m GS Administration 140/758V Bayer (Pty) Limited, South Africa 145 Tick Greese Cypermethrin % m/m GS Solution for Topical Administration 140/759V Bayer (Pty) Limited, South Africa 146 Vit A Plus 100ML Vitamin A IU + Vitamin E 50 IU Solution for Injection 140/760V Bayer (Pty) Limited, South Africa 147 Vit A Dex Injection Vitamin A IU + Vitamin D IU + Vitamin E 50 IU Solution for Injection 140/761V Bayer (Pty) Limited, South Africa 148 Zeropar aerosol Dichlorophen 1.0 % m/v + propetamphos 0.25% + pine oil GS Solution for Topical Administration 140/762V Bayer (Pty) Limited, South Africa 149 Infectious Coryza Vaccine Inactivated Haemophilus Paragallinarum Serotype A,B and C NLT 1x CFU per dose Use 326/001V Hester Biosciences Limited Page 9 of 40

10 New Castle Disease, Avian Infectious Bronchitis and Egg Drop Syndrome Infectious Bronchitis ZAMBIA MEDICINES REGULATORY AUTHORITY New Castle Disease 1x108.5 EID50 + Avian Infectious Bronchitis 1 x EID50 + Egg Drop 1 x EID50 per dose Use 326/002V Hester Biosciences Limited Vaccine Living NLT 1x EID 50 per dose Use 326/003V Hester Biosciences Limited New Castle Disease and New Castle Disease 1 x EID50 + Avian Infectious Bronchitis Avian Infectious Bronchitis 1 x vaccine, Inactivat EID50 per dose Use 326/004V Hester Biosciences Limited 152 Newcastle Disease 153 Vaccine,Living Not Less Than 1 X 106 EID50) Use 326/005V Hester Biosciences Limited Fowl Pox Vaccine, Living Fowl Pox Virus, Fowl Pox strain NLT B.P. Vet. X 102 TCID50 Use 326/006V Hester Biosciences Limited (Avian Infectious Bronchitis Virus, Mild Avian Infectious Bronchitis Mass. Type strain Not Less Than 1 X 155 Vaccine, Living EID50 Use 326/007V Hester Biosciences Limited Newcastle Disease Newcastle Disease Virus, LaSota strain 156 Vaccine,Living Not Less Than 1 X 106 EID50) Use 326/008V Hester Biosciences Limited Terramycin LA Injection ml Oxytetracycline 200mg per ml Solution for Injection 327/701V Zoetis South Africa (Pty) Ltd Derquantel 10mg + abamectin1mg per 158 Startect oral Drench ml Oral Solution 327/702V Zoetis South Africa (Pty) Ltd Draxxin solution for 159 injection Tulathromycin 100mg per ml Solution for Injection 327/703V Zoetis South Africa (Pty) Ltd Dectomax solution for 160 injection 500ml Doramectin 10mg per ml Solution for Injection 327/704V Zoetis South Africa (Pty) Ltd Dectomax solution for 161 injection 200ml Doramectin 10mg per ml Solution for Injection 327/705V Zoetis South Africa (Pty) Ltd Dectomax solution for 162 injection 50ml Doramectin 10mg per ml Solution for Injection 327/706V Zoetis South Africa (Pty) Ltd Dectomax solution for 163 injection 20ml Doramectin 10mg per ml Solution for Injection 327/707V Zoetis South Africa (Pty) Ltd Advocin Injectable solution ml Danofloxacin sulphate 25mg per ml Solution for Injection 327/708V Zoetis South Africa (Pty) Ltd Porcine parvovirus 640HA + Erysipelothrix rhusiopathiae 15.7RU Farrowsure plus B Vaccine Leptospir 1200NU per 0.05ml Solution for Injection 327/709V Zoetis South Africa (Pty) Ltd 166 Felocell 3 Vaccine Feline herpesvirus type 1 + calicivirus + panleukopenia virus Solution for Injection 327/710V Zoetis South Africa (Pty) Ltd Page 10 of 40

11 ZAMBIA MEDICINES REGULATORY AUTHORITY Fostera PCV Solution for Injection Porcine circovirus killed virus Solution for Injection 327/711V Zoetis South Africa (Pty) Ltd Glanvac 3 Injectable Clostridium pseudotuberculosis antigen vaccine 12CPU +60L + 6Lf Suspension for Injection 327/712V Zoetis South Africa (Pty) Ltd Improvac 100ml Gonadotropin Releasing Factor (GnRF) analogue-protein conjugate (a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid) min. 300 mcg Solution for injection 327/713V Zoetis South Africa (Pty) Ltd T. foetus 300,000,000 + C fetus strain Trichguard V5L Injectable 44,300,000,000 + C. fetus strain vaccine +55,600,000,000 + C. fetus strain Suspension for Injection 327/714V Zoetis South Africa (Pty) Ltd 171 VanGuard Plus 5 vaccine Canine distemper virus TCID50/mL + Canine adenovirus type 2, TCID50/mL, TCID50m/L, Solution for Injection 327/715V Zoetis South Africa (Pty) Ltd 172 Vanguard plus 5, 25 Doses Canine distemper virus + Canine adenovirus type 2 (CAV-2) + canine parainfluenza virus + a low passage, high titre canine parvovirus fraction Solution for Injection 327/716V Zoetis South Africa (Pty) Ltd 173 Valbazen For Sheep & Goats Albendazole 1.9% m/v P-V Use 327/717V Zoetis South Africa (Pty) Ltd 174 Equest Plus Tape Moxidectin 2%m/m + Praziquantel 12.5% P-V Paste for oral use 327/719V Zoetis South Africa (Pty) Ltd 175 Cerenia Injection maropitant citrate Solution for Injection 327/720V Zoetis South Africa (Pty) Ltd 176 Avipro 105 ND Vaccine Newcastle disease virus 0.5ml/dose Use 328/701V Immuno-Vet Services (Pty) LTD 177 Avipro 106 Reo Vaccine Avian Reo virus 0.5ml per dose Solution for Injection 328/702V Elanco Animal Health 178 Avipro 107EDS Vaccine Egg drop syndrome inactivated adenovirus Solution for Injection 328/703V Elanco Animal Health 179 Avipro 303 ND -IB -EDS Vaccine Newcastle disease viruses, ulster 2C strain infectious Solution for Injection 328/704V Elanco Animal Health 180 Avipro 441 ND -1B -BTO Reo Vaccine Basal Disease -Newcastle disease bronchitis Reovirus Solution for Injection 328/705V Elanco Animal Health 181 Avipro AE Vaccine Avian Encephalomylitis Virus Solution for Injection 328/706V Elanco Animal Health 182 Aviblue Powder (Patent blue 1.53% + Sodium Thiosulphate anhydrate 16% + Sodium Hydrogen Carbonate 18% + Sodium carbonate 4.5% + Citric acid anhydrate 9%) per 375g GS Powder for Oral Solution 328/707V Elanco Animal Health Page 11 of 40

12 183 Avipro Diludrop 184 Avipro Gumboro vaccine 185 Avipro ILT Vaccine 186 Avipro MD LYO Vaccine (Povidone 20mg + Na Cl 4.5mg + Sodium Hydrogen Phosphate, 4.1mg + Di Sodium Hydrogen Phosphate 7mg + Patent blue V (E131) 50ug) per 34 ml Solution for Injection 328/708V Elanco Animal Health Infectious basal disease (IBD) Live Virus strain Solution for Injection 328/709V Elanco Animal Health Infectious Laryngiotracheitis (ILT) Live virus Minimum antigenic content per dose at release is 1 Solution for Injection 328/710V Elanco Animal Health Marek's disease vacc., live virus, FC 126 strain; Minimum antigenic content per dose at release is 10Ʌ 3 EID50 Newcastle disease virus, strain LaSota Solution for Injection 328/711V Immuno-Vet Services (Pty) LTD 187 Avipro ND Lasota Vaccine Newcastle Disease (ND), live virus, FC 126 strain; Minimum antigenic content per dose at release is 10Ʌ 6 EID50 Newcastle disease virus, strain LaSota Solution for Injection 328/712V Elanco Animal Health 188 Avipro POX CEO Vaccine Avian Enchephalomyelitis -Fowl pox virus Solution for Injection 328/713V Elanco Animal Health 189 Avipro Precise Vaccine Infectious Bursal Disease (IBD) Live Virus strain Solution for Injection 328/714V Elanco Animal Health 190 Avipro Salmonella VAC E Vaccine Salmonella enteriditis bacteria strain Sm24/Rif12/Ssq; 100 doses + applicable 200ml diluent Solution for Injection 328/715V Elanco Animal Health 191 Avipro Salmonella Vac T Vaccine Salmonella typhimurium bacteria, stra Solution for Injection 328/716V Elanco Animal Health 192 Talovac 201 1B INB Vaccine Bronchitis virus mass 41, Strain Newcastle disease virus Uls Solution for Injection 328/717V Immuno-Vet Services (Pty) LTD 193 AviPro Thymovac Live Chicken Anaemia Virus (CAV), strain Cux-1: TCID50* Lyophisilate for use in drinking water 328/718V Elanco Animal Health 194 Avibacterium paragallinarum Modesto Avipro 101 Coryza Vaccine strain, Serotype C; 500ml (1000doses) Solution for Injection 328/719V Elanco Animal Health 195 Avipro 104 M9 Bacterin Mycoplasma gallisepticum bacterin Solution for Injection 328/720V Elanco Animal Health 196 Avipro 105 ND Chick Vaccine Newcastle disease virus 0.1ml per dose Use 328/721V Elanco Animal Health Page 12 of 40

13 197 Avipro 108 FC Vaccine Inactivated Pasturella multocida Bacterin, Avian Isolates, Type 1, 3, 4 and 3 x 4 Use 328/722V Elanco Animal Health 198 Avipro 109 se4 Vaccine Salmonella enteritis 0.5ml per dose Use 328/723V Elanco Animal Health 199 Avipro 304 ND -1B-MG Vaccine Newcastle disease bronchitis reovirus Solution for Injection 328/724V Elanco Animal Health 200 Avipro AE Pox Vaccine Avian Encephalomylitis vaccine, live virus, strain Calnek 1143 Solution for Injection 328/725V Immuno-Vet Services (Pty) LTD 201 Cymigard Dip Cymiazol 2% w/v + Cypermethrin 1%w/v GS Solution for Topical Use 329/701V Chemical Process Technologies (Pty) 202 Rabisin vaccine Rabies virus glycoproteins 1IU Suspension for Injection. 330/701V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 203 Eqvalan Gold Ivermectin 1.55% w/w + and Praziquantel 7.75% w/w Oral paste 330/702V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 204 Frontline Plus Cats Solution Fipronil 10% w/v + methoprene 12% w/v GS Solution for Topical Use 330/703V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 205 Frontline Plus Dogs Large Fipronil 10% w/v + methoprene 9% w/v GS Solution for Topical Use 330/704V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 206 Frontline Plus Dogs Medium Fipronil 10% w/v + methoprene 9% w/v GS Solution for Topical Use 330/705V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 207 Frontline Plus Dogs Small Fipronil 10% w/v + methoprene 9% w/v GS Solution for Topical Use 330/706V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 208 Frontline Plus Dogs X- Large Fipronil 10% w/v + methoprene 9% w/v GS Solution for Topical Use 330/707V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 209 Frontline Spray Fipronil 2.5 mg/ml GS Solution for Topical Use 330/708V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 210 Ivomec Injection Ivermectin 1% w/v per ml Solution for Injection 330/709V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 211 Ivomec Super Ivermectin 1% w/v + Clorsulon 10% w/v Solution for Injection 330/710V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 212 Novidium Homidium Chloride 250mg per tablet Tablet 330/711V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 213 Trypamidium Samorin powder for injection Isometamidium Chloride 100% w/v Powder for Injection 330/712V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 214 Trodax Injection Nitroxynil Injection BP (Vet) 34% w/v Solution for Injection 330/713V Boehringer Ingelheim Animal Health South Africa (Pty) Ltd. 215 Crestar Implant Norgestomet 3.0 mg POM Implant 331/701V MSD Intervet SA Cobactan 2.5% suspension for injection Cefquinome 25mg/ml POM Suspension for Injection 331/702V MSD Intervet SA 216 Page 13 of 40

14 Attenuated freeze dried viral vaccine(avian Encephalomyelitis virus 217 Nobilis AE + Pox Vaccine strain) POM Suspension for Injection 331/703V MSD Intervet SA 218 Nobilis Bumboro 228E Vaccine Strain 083 Serotype A + Strain Spross Serotype B + Strain H-18 Serotype C + Strain 48 POM Suspension for Injection 331/704V MSD Intervet SA Nobilis IB H120 Live virus Live Infectious Bronchitis Virus H vaccine 3.0log EID50 POM Suspension for Injection 331/705V MSD Intervet SA Live Infectious Bronchitis Virus 3.0 log Nobilis Ma5 + Clone30 live 10 EID50 + Massachusetts strain viral vaccine log 10 EID50 + Liv POM Emulsion for Injection 331/706V MSD Intervet SA Nobilis REO 2177 live vaccine Reovirus strain 3.1 log10 TCID50 POM Suspension for Injection 331/707V MSD Intervet SA Nobilis Ma5 + Clone30 live viral vaccinelive Infectious Bronchitis Virus serotype Massachusetts strain Ma5 at least 3.0 log10 EID50 + Live Newcastle Disease Virus, strain Clone 30 at least 6.0 log10 EID50) Nobilis REO 2177 live vaccine Nobilis Reo+IB+G+ND inactivated vaccine Paracox oral vaccine Live Infectious Bronchitis Virus serotype Massachusetts strain Ma5 at least 3.0 log10 EID50 + Live Newcastle Disease Virus, strain Clone 30 at least 6.0 log10 EID50) Solution for Injection 331/708V MSD Intervet SA Live Reovirus strain 2177 at least 3.1 log10 TCID50 per dose Solution for injection 331/709V MSD Intervet SA Inactivated vaccine, Infectious Bronchitis virus Massachusetts serotype strain 41inducing 6 log 2 HI units per dose + Newcastle Disease virus Clone 30 inducing 50 PD 50 units + Gumboro virus strain D78 inducing 14,5 log 2 VN units + Reo virus strains 1733 and 2408 inducing 7.4 log 2 ELISA units Solution for Injection 331/710V MSD Intervet SA Eimeria acervulina HP E. brunette HP E. maxima CP E. maxima MFP E. mitis HP E. necatrix HP E. praecox HP E. tenella HP 500 per dose Solution for oral use 331/711V MSD Intervet SA Page 14 of 40

15 Chorulon Powder for Injection Covexintm 10 Vaccine Coccivac-D Liquid Live Oocysts Vaccine Nobilis Gumboro 228E Live Vaccine Nobilis Coryza Vaccine Nobilis EDS Vaccine ZAMBIA MEDICINES REGULATORY AUTHORITY Chorionic Gonadotrophin IU, 5 x 5 ml freeze-dried cake and 5 x 5 ml Solvent for reconstitution POM Suspension for Injection 331/712V MSD Intervet SA C. chauvoei whole culture + C. haemolyticum toxoid + C. novyi type B toxoid + C. perfringens type A toxoid + C.perfringens type B toxoid + C. perfringens type C toxoid + C. perfringens t ype D toxoid + C. septicum toxoid + C. tetani toxoid + C. sordellii toxoid Solution for Injection 331/713V MSD Intervet SA E. acervulina Not less than 600 oocyst + E. maxima Not less than 200 oocyst + E. mivati Not less than 400 oocyst + E. tenella Not less than 200 oocyst + E. necatrix Not less than 400 oocyst + E. brunetti Not less than 200 oocyst + E. hagani Not less than 400 oocyst + E. praecox Not less than 400 oocyst per dose Solution for Topical use 331/714V MSD Intervet SA Live avian Infectious Bursal Disease virus, strain 228E At least 2.0 log10 EID 50 per dose suspension for oral administration 331/715V MSD Intervet SA Inactivated strains of the serotypes A, B and C of Avibacterium paragallinarum at least 1 CPD 70 (70 % chicken protective dose) of each serotypes per dose Solution for Injection 331/716V MSD Intervet SA Formaldehyde inactivated EDS virus strain BC14 inducing 6,5 log2 HI units per dose solution for Injection 331/717V MSD Intervet SA Nobilis Gumboro D78 Live Vaccine Nobilis IB+G+ND Vaccine Live Gumboro disease virus strain D78 at least 4.0 log10 TCID50 per bird dose Suspension for Oral Use 331/718V MSD Intervet SA Inactivated IB strain M41 6,0 log2 HI units + ND Clone PD50 + Gumboro strain D78: 12,5 log2 VN units per dose Suspension for Oral Use 331/719V MSD Intervet SA Page 15 of 40

16 Nobilis IB+ND Vaccine Nobilis MG Inac Vaccine Nobilis ND C2 Vaccine ZAMBIA MEDICINES REGULATORY AUTHORITY One immunogenic strain of Infectious Bronchitis virus (Massachusetts serotype) inducing 6,0 log 2 HI units + one strain of Newcastle Disease virus containing 50 PD 50 Solution for Injection 331/720V MSD Intervet SA Mycoplasma gallisepticum, strain S6/85, bacterial concentrate inactivated by thiomersal,23 OD units of Mycoplasma gallisepticum, strain S6/85 Solution for Injection 331/721V MSD Intervet SA Live attenuated Newcastle disease virus (NDV) strain C2 5,7 7,5 log 10 EID 50 of NDV strain C2 per dose Solution for Topical Use 331/722V MSD Intervet SA Nobilis SG 9R Live Vaccine Nobilis ND Lasota Live Vaccine Nobilis Rismavac Vaccine Nobilis Salenvac T Live Salmonella gallinarum organisms strain 9R >2 x 10 7 CFU per dose Solution for Topical Use 331/723V MSD Intervet SA Newcastle Disease virus strain LaSota at least 10 6 ELD 50 per dose Use 331/724V MSD Intervet SA Live vaccine containing Marek Disease virus serotype 1, strain CVI-988 3,0 log 10 TCID 50 serotype 1, strain CVI-988 per dose Suspension for Oral Use 331/725V MSD Intervet SA Formalin killed cells of Salmonella enteridtidis phage type 4 PT4: 2 x 10 9 cells/ml + Salmonella typhimurium DT104: 2 x 10 9 cells/ml Suspension for Injection 331/726V MSD Intervet SA 241 Receptal Solution for Injection Buserelin acetate mg per ml Solution for injection 331/727V MSD Intervet SA 242 Salix solution for injection Furosemide 50mg per ml Solution for injection 331/728V MSD Intervet SA 243 Bimadine Powder, 25g Sulfadimidine 99.01w/w% Powder for Oral Suspension 332/701V Bimeda 244 Bimahistamine Injection Tripelennamine Hydrochloride 20mg per ml Solution for Injection 332/702V Bimeda 245 Bimastat Oral Suspension Neomycin Sulphate 2.5% w/w + Sulphadiazine + Kaolin 15% w/w Suspension for Oral Use 332/703V Bimeda 246 Bimectin Horse Oral Paste Ivermectin 18.7mg per g Oral Paste 332/704V Bimeda 247 Buparvex Injection 50 ml Buparvaquone 50mg/ml Solution for Injection 332/705V Bimeda Page 16 of 40

17 248 Buparvex Injection 100 ml Buparvaquone 50mg/ml Solution for Injection 332/706V Bimeda 249 Cronyxin Injection, 50 ml Flunixin Meglumine 50mg, per ml Solution for Injection 332/707V Bimeda 250 Cronyxin Injection, 100 ml Flunixin Meglumine 50mg, per ml Solution for Injection 332/708V Bimeda 251 Embotape Oral Paste Pyrantel embonate 11.4 g per 28.5 g P-V Oral Paste 332/709V Bimeda 252 Endofluke 100mg/ml Oral Triclabendazole 100mg per ml Suspension for Oral Use 332/710V Bimeda 253 Endospec 10% Albendazole 100mg per ml Suspension for Oral Use 332/711V Bimeda 254 Flunazine Injection 100ml Flunixin Meglumine 50mg per ml Solution for Injection 332/712V Bimeda 255 Flunazine Injection 250ml Flunixin Meglumine 50mg per ml Solution for Injection 332/713V Bimeda 256 Multimast DC Suspension 257 Oxycomplex injection 258 SpectoGard Scour-Chek 259 Teat Seal 260 Tetroxy LA Injection Neomycin sulphate 100 mg + Penethamate hydriodide 100 mg + Procaine Benzylpenicillin 400 mg) per 4.5g Oxytetracycline 100mg/ml + Flunixin Suspension for intramammary administration 332/714V Bimeda Meglumine 20mg/ml per 100ml Solution for Injection 332/715V Bimeda Spectinomycin dihydrochloride 50mg per ml Use 332/716V Bimeda Cloxacillin Benzathine 600mg + Intramammary Bismuth Subnitrate 2.6g suspension 332/717V Bimeda Oxytetracycline Dihydrate 200mg per ml Solution for Injection 332/718V Bimeda 261 Tonavet Oral Suspension Multivitamins + Minerals GS Suspension for Oral Use 332/719V Bimeda 262 Vitamin B1 injection Thiamine Hydrochloride 100mg per ml Solution for Injection 332/720V Bimeda 263 Vitamin K1 Injection Phytomenadione 10mg per ml Solution for Inhalation 332/721V Bimeda 264 Albendazole Oral Suspension 10% Albendazole 10% W/V Suspension for Oral 332/722V Bimeda 265 Bilosin injection, 100mL Tylosin base 200mg per ml Solution for Injection 332/723V Bimeda 266 Buvonal injection, 20mL Buparvaquone 50mg per ml Solution for Injection 332/724V Bimeda 267 Buvonal injection, 50mL Buparvaquone 50mg per ml Solution for Injection 332/725V Bimeda 268 Curafluke Drench 5% Fenbendazole + Rafoxanide 50mg per ml Suspension for Oral Use 332/726V Bimeda 269 Cyperguard Emulsifiable Concentrate 10% Cypermethrin 100g per litre GS Solution for Topical Use 332/727V Bimeda 270 Dipen injection, 50mL Procaine Benzylpenicillin 200mg + dihydrostreptomycin 200mg per ml Solution for Injection 332/728V Bimeda Page 17 of 40

18 271 Dipen injection, 100mL ZAMBIA MEDICINES REGULATORY AUTHORITY Procaine Benzylpenicillin 200mg + dihydrostreptomycin 200mg per ml Solution for Injection 332/729V Bimeda 272 Gallimycin injection, 100mL Erythromycin Base 100mg per ml Solution for Injection 332/730V Bimeda Helo Dip Tea Dip 273 Concetrate. Ammonium Lauryl Sulphate 3.1% W/V GS Solution for Topical Use 332/731V Bimeda 274 Nutravit oral powder, 100gm Multivitamins +Minerals GS Powder for Oral Solution 332/732V Bimeda 275 Osmodex Liquid Disinfectant Iodophor-detergent disinfectant 1.99% w/w (2.3% w/v) of available iodine GS Liquid Detergent 332/733V Bimeda 276 Vermofas Drench Levamisole Hydrochloride 15mg/ml and Oxyclozanide GS Suspension for Oral Use 332/734V Bimeda 277 Parvexon Plus Injection Parvaquone 150mg + Frusemide 55mg per ml Solution for Injection 332/735V Bimeda 278 Parvexon Plus Injection, 100ml Parvaquone 150mg + Frusemide 55mg per ml Solution for Injection 332/736V Bimeda 279 Bimectin 1% solution for injection, 100mL Ivermectin 1.0 %w/v (10mg per ml) Solution for Injection 332/737V Bimeda 280 Albendazole Oral Suspension 10% Albendazole 100mg in 1 ml. 10% Suspension for Oral Use 332/772V Bimeda 281 Fosbac Plus T Water Soluble Powder Calcium Fosfomycin 20% + Tylosin Tartrate 5% + Fructose diphospha 1.6 % GS Powder for Oral Use 333/701V Bupo Animal Health 282 Bedgen 40 premix Choline chloride + Artichoke dry extract GS Powder for Feed 333/702V Bupo Animal Health Choline chloride + Cynara Artichoke 283 Bedgen 40 liquid Dry Extract GS Use 333/703V Bupo Animal Health 284 Fosbac Plus T premix Calcium Fosfomycin 20.00% w/w + Tylosin tartrate 5.0% w/w + Fructose 1,6 diphosphate 18.00%w/w + Sodium Phosphate 15.00%w/w + Magnesium Sulphate heptahydrate 10.00%w/w GS Powder for Feed 333/705V Bupo Animal Health Page 18 of 40

19 285 Amilyte water soluble powder Vitamin A500 WS (Retinyl Acetate) Vitamin D3 (Cholecalciferol) Vitamin E50 WS (Alpha- Tocopheryl Acetate) Vitamin K 50% (Menadione Sodium Bisulfite) Vitamin B1 (Thiamine Mononitrate) Vitamin B2 80% (Riboflavin) Vitamin B6 (Pyridoxine Hydrochloride) Vitamin B12 (Cyanocobalamin) Vitamin C (Ascorbic Acid) Biotin WS Folic Acid Nicotinic Acid (Nicotinamide) D- Calcium Pantothenate Magnesium Sulphate Potassium Chloride Sodium Chloride L-Lysine Hydrochloride DL- Methionine L-Threonine Citric Acid GS Water Soluble Powder for Oral Administration 334/701V Zagro Singapore Pte Ltd 286 Calpozag Oral Liquid Calcium Chloride Dihydrate g + Magnesium chloride 35.78g + Potassium Chloride 5.77g + Propylene Glycol 60.00g per liter P-V Administration 334/702V Zagro Singapore Pte Ltd 287 Nilstress Water Soluble Powder Vitamin A 500 WS (Retinyl Acetate) Vitamin D3 (Cholecalciferol) Vitamin E 50 WS + (Alphaocopheryl Acetate) Vitamin B2 98% (Riboflavin) Vitamin B6 (Pyridoxine Hydrochloride) Vitamin B12 (Cyanocobalamin) Vitamin C (Ascorbic Acid) Folic Acid Nicotinic Acid (Nicotinamide) Magnesium Sulphate Potassium Chloride Sodium Chloride Citric Acid GS Water Soluble Powder for Oral Administration 334/703V Zagro Singapore Pte Ltd Page 19 of 40

20 288 Zagrosol AD3E Oral Liquid ZAMBIA MEDICINES REGULATORY AUTHORITY Vitamin A Palmitate mg + Vitamin D3 oil 4.00 mg + Vitamin E oil mg per ml GS Administration 334/704V Zagro Singapore Pte Ltd Vitamin A 500 WS (Retinyl Acetate) 14.00g + Vitamin D3 (Cholecalciferol) 2.00g + Vitamin E 50 WS (Alpha- Tocopheryl Acetate) 4.00g + Vitamin K 50% (Menadione Sodium Bisulfite) 4.00g + Vitamin B1 (Thiamine Mononitrate) Vitamin B2 98% (Riboflavin) 2.04g + Vitamin B6 (Pyridoxine Hydrochloride) 1.02g + Vitamin B12 (Cyanocobalamin) 0.70g + Vitamin C (Ascorbic Acid) 25.25g + Folic Acid 0.31g + Nicotinic Acid (Nicotinamide)15.15g + D-Calcium Pantothenate 8.16g + L-Lysine 10.20g Zeggbooster Water Soluble + DL-Methionine 10.20g + Water Soluble Powder for 289 Powder Lactobacillus sp. 1.00g per kg GS Oral Administration 334/705V Zagro Singapore Pte Ltd 290 Closeco 7.5% injectable solution Closantel 7.5% Solution for Injection 335/701V Eco animal Health Southern Africa (Pty) limited 291 Ecobash Cattle Dip and Spray Cymiazol 17.5% m/v+ Cypermethrin 2.5% m/v GS Solution for Topical Use 335/702V Eco animal Health Southern Africa (Pty) limited 292 Ecofluke Suspension Triclabendazole 10% P-V Suspension for Oral Use 335/703V (Pty) limited 293 Ecomintic 50 oral drench Fenbendazole 5% w/v P-V Suspension for Oral Use 335/704V (Pty) limited 294 Ecotel 2.5% suspension Praziquantel 2.5 % m/v P-V Suspension for Oral Use 335/705V (Pty) limited 295 Ecox 200mg microgranules Monensin Sodium 200mg per g Granules for Oral Use 335/706V Eco animal Health Southern Africa (Pty) limited Exit topical liquid Deltamethrin 0.1 % + Piperonyl butoxide 0.5 % + High Boiling GS Solution for Topical Use 335/707V Eco animal Health Southern Africa (Pty) limited 296 Tar Acid 0.5 % + Colophony Resin 17.60% 297 Flaveco 80 powder Flavomycin 80g per kg Powder for Oral Use 335/708V (Pty) limited 298 Salecox 120 powder Salinomycin Sodium 120g per kg Powder for Oral Use 335/709V (Pty) limited 299 Tyleco FG 100 Powder Tylosin phosphate 10 % m/m Powder for Oral Use 335/710V (Pty) limited 300 Tyleco FG 250 Powder Tylosin phosphate 25 % m/m Powder for Oral Use 335/711V (Pty) limited 301 Doraject + AD3E LA, injection Doramectin 1 % + Vitamin A 3.3 % +Vitamin E 5 % +Vitamin D % Solution for Injection 336/701V Cipla Agrimed Limited Page 20 of 40

21 302 Endo-Lint Oral Dreanch 303 Rednil Injectable Solution 304 Trinex Plus 19.5% 305 AD3E Injectable Solution 306 Complex AD3E + Minerals Injectable Solution ZAMBIA MEDICINES REGULATORY AUTHORITY Levamisole HC137.5 mg + Praziquantel18.8 mg per ml P-V Suspension for Oral Use 336/702V Cipla Agrimed Limited Diminazene 70 mg +Phenazone 375 mg) per 100ml Solution for Injection 336/703V Cipla Agrimed Limited Triclabendazole 12,0 % m/v + Suspension for Oral Levamisole 7.5 % m/v P-V Administration 336/704V Cipla Agrimed Limited Vitamin A IU +Vitamin E 5 IU +Vitamin D IU per ml Solution for Injection 336/705V Cipla Agrimed Limited Vitamin A IU + Vitamin E 10 IU +Vitamin D IU +Cobalt 0.15 mg +Copper 2.54 mg +Zinc 1.82 mg +Selenium 0.7 mg per ml Solution for Injection 336/706V Cipla Agrimed Limited Cymiazole17.5% + Cypermethrin2.5 % 307 Bantik Cattle Dip GS Solution for Topica Use 336/707V Cipla Agrimed Limited 308 Coni fluke + Tape Oral Drench Resorantel 25 % m/v P-V Suspension for Oral Use 336/708V Cipla Agrimed Limited 309 Doxycip 50 % Water Soluble Powderr Doxycycline hyclate 500 mg per g Water Soluble Powder for Oral Administration 336/709V Cipla Agrimed Limited 310 Ectoshield Oil emulsion Amitraz 1.75% m/v+ Cypermethrin 1.5 % m/v GS Solution for Topical use 336/710V Cipla Agrimed Limited 311 Endoject + Fluke Injection Closantel 7.5 % m/v Solution for Injection 336/711V Cipla Agrimed Limited 312 Ivermax + AD3E Injection Ivermectin 1% Solution for Injection 336/712V Cipla Agrimed Limited 313 Ivermax Metabolic Injection Ivermectin 1% Solution for Injection 336/713V Cipla Agrimed Limited 314 Ivermax 1% Injection Ivermectin 1% Solution for Injection 336/714V Cipla Agrimed Limited 315 Maxitet 10% Injection Oxytetracycline hydrochloride 10% Solution for Injection 336/715V Cipla Agrimed Limited 316 Nemarox Oral drench Levamisole 2.5 % m/v +Rafoxanide 2.5 % m/v P-V Administration 336/716V Cipla Agrimed Limited Ivermectin 0.2 % m/v + Triclabendazole 10.0 % m/v + Levamisole 8.0 % m/v Administration 336/717V Cipla Agrimed Limited 317 Ovidose 3 Oral drench P-V Dichlorvos 1.6 g+cypermethrin 0.37 g + Sulfadiazine 0.11 g + Piperonyl butoxide g per 100 ml 318 Supaspray Plus GS Solution for Topical Use 336/718V Cipla Agrimed Limited Supertraz 25% 319 Emulsifiable concentrate Amitraz 25 % m/v GS Solution for Topical Use 336/719V Cipla Agrimed Limited Page 21 of 40

22 320 Supertraz 12.5 Emulsifiable concentrate Amitraz 12.5 % m/v GS Solution for Topical Use 336/720V Cipla Agrimed Limited 321 Supertraz Cattle Pour On Amitraz 2.0 % m/v GS Solution for Topical Use 336/721V Cipla Agrimed Limited 322 Maxi-Sulf LA Injection Sodium Sulfadimethoxine 40 % m/v Solution for Injection 336/722V Cipla Agrimed Limited 323 Maxicyp 20% Dip Concentrate Cypermethrin 200g per L GS Solution for Topical Use 336/723V Cipla Agrimed Limited 324 Maxipour Pour-on Flumethrin 1% GS Solution for Topical Use 336/724V Cipla Agrimed Limited 325 Maxifluke suspension Triclabendazole 10.0 % m/v P-V Suspension for oral use 336/725V Cipla Agrimed Limited 326 Maxi-Lint Suspension Praziquantel 2.5% P-V Suspension for oral use 336/726V Cipla Agrimed Limited 327 Maxitet 13.5% Oxytetracycline 135 mg per ml Solution for Injection 336/727V Cipla Agrimed Limited 328 Pegaforte Ivermectin 12 mg + Praziquantel 150 mg per g Solution for Injection 336/728V Cipla Agrimed Limited 329 Deltadip 5% SC Deltamethrin 5% GS Solution for Topical Use 336/729V Cipla Agrimed Limited 330 Deltadip Pour On Deltamethrin 0.5 % m/v + Piperonyl butoxide 2.5 % m/v GS Solution for Topical use 336/730V Cipla Agrimed Limited 331 Larvanil Cyromazine (triazine) 10g/Kg GS Solution for Topical Use 336/731V Cipla Agrimed Limited 332 Expel Wound Spray Deltamethrin 0.10% + High boiling tar acid 0.468% w/w + Linseed oil % w/w + Gum turpentine % w/w) GS Solution for Topical Use 337/701V Afrivet Business Management (Pty) Ltd 333 Ultratet LA injection Oxytetracycline Hydrochloride 230mg/ml) Solution for Injection 337/702V Afrivet Business Management (Pty) Ltd 334 Ultratet solution for injection Oxytetracycline HCL 125mg/ml) Solution for Injection 337/703V Afrivet Business Management (Pty) Ltd 335 Triatix - D Dip Amitraz 12.5% GS Solution for Topical Use 338/701V Cooper Zimbabwe (Pvt) Limited Deltamethrin 0.1%w/w + Piperonyl butoxide 0.5% w/w 336 Tick Grease GS Gel Topical 338/702V Cooper Zimbabwe (Pvt) Limited 337 Deca - Spot 0.5% spot on Deltamethrin 0.5% + Piperonyl Butoxide 2.5% GS Solution for Topical Use 338/703V Cooper Zimbabwe (Pvt) Limited 338 Golden Mastrite topical liquid Iodine as Iodophore 12% GS Solution for Topical Use 338/704V Cooper Zimbabwe (Pvt) Limited 339 Healing Oil Topical Phenols 0.52% GS Solution for Topical Use 338/705V Cooper Zimbabwe (Pvt) Limited 340 Triatix Cattle Plus pour on Amitraz 1.5% + Deltamethrin 0.50% + Piperonyl butoxide 3.0% GS Solution for Topical Use 338/706V Cooper Zimbabwe (Pvt) Limited 341 Triatix Cattle Plus pour on Amitraz 2% GS Solution for Topical Use 338/707V Cooper Zimbabwe (Pvt) Limited 342 Triatix - Dip and Spray Amitraz 12.5% GS Solution for Topical Use 338/708V Cooper Zimbabwe (Pvt) Limited 343 Xylazine 2% injection Xylazine HCl 2% Solution for Infusion 339/701V Alfasan International BV 344 Albendazole bolus Albendazole 2500 mg per bolus P-V 339/701V Alfasan International BV Page 22 of 40