GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA. N$43.60 WINDHOEK - 21 September 2012 No. 5042

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1 GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA N$43.60 WINDHOEK - 21 September 2012 No CONTENTS Page GOVERNMENT NOTICES No. 244 of certain medicines: Medicines and Related Substances Control Act, No. 245 of certain medicines: Medicines and Related Substances Control Act, Government Notices MINISTRY OF HEALTH AND SOCIAL SERVICES No REGISTRATION OF CERTAIN MEDICINES: MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 In terms of section 23 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), I give notice that the medicines set out in the have been registered in terms of that Act, subject to the following conditions: (a) (b) (c) (d) the manufacture and control of medicines must be in accordance with the existing current Good Manufacturing Practices as required by the World Health Organisation; in order to assess compliance with paragraph (a), inspections and investigations may be carried out regularly by inspectors authorised in terms of section 35 of the Act; the information in the package insert must, on a regular basis, be updated to conform with the package insert approved by the Council; the holder of a certificate of, referred to in section 19(7) of the Act, must comply with the Act;

2 2 Government Gazette 21 September (e) (f) (g) (h) the of a medicine is subject to regular review regarding its quality, safety and efficacy and the Council may, as it considers necessary, vary the of such medicine; the first two production batches must be validated in accordance with the detailed process validation protocol, which was submitted at the time of the application for ; a validation report must be submitted to the Council within one month from the date of completion of the validation referred to in paragraph (f); and the Council may review the dossier at such intervals as the Council may determine. J. GAESEB REGISTRAR OF MEDICINES Windhoek, 5 September 2012 SCHEDULE S/N APPLICANT PROPRIETARY NAME Milan Laboratories (India) Pvt Milan Laboratories (India) Pvt Milan Laboratories (India) Pvt Milan Laboratories (India) Pvt Milan Laboratories (India) Pvt Milan Laboratories (India) Pvt Milan Laboratories (India) Pvt Milan Laboratories (India) Pvt Cipla-Medpro (Pty) ML-Cotri Suspension Milmaleate Tablets APPROVED NAME OF ACTIVE(S) Sulphamethoxazole, Trimethoprim Chlorpheniramine Maleate REG. NUMBER 12/20.2/ /5.7/0101 Metro Forte Suspension Metronidazole Benzoate 12/20.2.6/0102 Metronidazole Tablets BP 400 mg Cloxacillin Capsules USP 250 mg Betrim-480 Phenoxymethylpenicillin Oral Solution 250 mg/5ml Phenoxymethylpenicillin Oral Solution 125 mg/5ml Odimune 10 Oshakati Pharmacy Tensopyn Paediatric Syrup Pharma Dynamics (Pty) Cipla-Medpro (Pty) Cipla-Medpro (Pty) Cipla-Medpro (Pty) Cipla-Medpro (Pty) Cipla-Medpro (Pty) Cipla-Medpro (Pty) Metronidazole 12/20.2.6/0103 Cloxacillin Sodium 12/20.1.2/0104 Sulphamethoxazole, Trimethoprim Phenoxymethylpenicillin Potassium Phenoxymethylpenicillin Potassium Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Paracetamol, Codeine Phosphate 12/20.2/ /20.1.2/ /20.1.2/ /20.2.8/ /21.2/0109 Dyna Gliclazide SR 30 mg Gliclazide 12/21.2/0110 Cipla-Paclitaxel 100mg/16.7ml Paclitaxel 12/26/0111 Cipla-Paclitaxel 30mg/5ml Paclitaxel 12/26/0112 Cipla-Paclitaxel 300mg/50ml Paclitaxel 12/26/0113 Alkafizz Effervescent Granules Combination 12/18.3/0114 Cipla Docetaxel 80 Docetaxel Trihydrate 12/26/0115 Solvent for Cipla Docetaxel 80 Ethanol 13,0 % m/v 12/32.2/0116

3 5042 Government Gazette 21 September Cipla-Medpro (Pty) Cipla Docetaxel 20 Docetaxel Trihydrate 12/26/ Cipla-Medpro (Pty) Solvent for Cipla Docetaxel 20 Ethanol 13,0 % m/v 12/32.2/ Roche Products (Pty) CellCept Mycophenolate Mofetil 12/34/ Roche Products (Pty) CellCept 500 Mycophenolate Mofetil 12/34/ Adcock Ingram Aco-Lamivudine 300mg tablets Lamivudine 12/20.2.8/ Janssen Pharmaceutica (Pty) Topamax SC 15 Topiramate 12/2.5/ Meyerzelll Laboratories (Pty) Covarex Cream Miconazole Nitrate 12/13.9.2/ Adcock Ingram Adco-Mirteron 30 Mirtazapine 12/1.2/ Adcock Ingram Adco-Mirteron 15 Mirtazapine 12/1.2/ Novartis SA (Pty) Exforge 5/320 Amlodipine Besylate, Valsartan 12/7.1.3/ Novartis SA (Pty) Exforge 10/320 Amlodipine Besylate, Valsartan 12/7.1.3/ Novartis SA (Pty) Galvus Met 50/850 Vildagliptin, Metformin 12/21.2/ Novartis SA (Pty) Galvus Met 50/1000 Vildagliptin, Metformin 12/21.2/ Sandoz SA (Pty) Hexal-MPA 5 Medroxyprogesterone Acetate 12/21.8.2/ Sandoz SA (Pty) Hexal-MPA 10 Medroxyprogesterone Acetate 12/21.8.2/ Sandoz SA (Pty) Fluvoxamine-Hexal 100 Fluvoxamine Maleate 12/1.2/ Sandoz SA (Pty) Cetirizine-Hexal 1mg/ml Oral Solution Cetirizine Dihyrochloride 12/5.7/ Sandoz SA (Pty) Cetirizine-Hexal 10 mg Cetirizine Dihyrochloride 12/5.7/ Sandoz SA (Pty) BisoHexal 5 Bisoprolol Fumarate 12/5.2/ Sandoz SA (Pty) BisoHexal 10 Bisoprolol Fumarate 12/5.2/ Adcock Ingram Nebilet 5 mg Nebivolol Hydrochloride 12/7.1.3/ Pharma Dynamics (Pty) Dyna Indapamide SR Indapamide 12/7.1/0138 MINISTRY OF HEALTH AND SOCIAL SERVICES No REGISTRATION OF CERTAIN MEDICINES: MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 In terms of section 23 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), I give notice that the medicines set out in the are registered subject to the following conditions: (a) (b) the manufacture and control of the medicine must be in accordance with the existing Good Manufacturing Practices as required by the World Health Organization; in order to assess compliance with paragraph (a), inspections and investigations may be carried out regularly by inspectors authorized in terms of section 35 of the Act;

4 4 Government Gazette 21 September (c) (d) (e) (f) (g) (h) the information contained in the package insert must, on a regular basis, be updated to conform with the package insert approved by the Medical Control Council; the holder of the certificate of which is referred to in section 19 (7) of the Act, must comply with the Act ; the of medicine is subject to regular review regarding its quality, safety and efficacy, and the Council may, as it considers necessary, vary the conditions of of the medicine; the first two production batches must be validated in accordance with the detailed process validation protocol which was submitted at the time of the application for ; a validation report must be submitted to the Council within one month from the date of completion of the validation referred to in paragraph (e); and the council may review the dossier at such intervals as the council may determine. J. GAESEB REGISTRAR OF MEDICINES Windhoek, 5 September 2012

5 5042 Government Gazette 21 September SCHEDULE Zerorab V10/24.1/885 0 Coopers Ticks Grease V05/18.3.3/406 0 Deltamethrin 98% Inact.Rabies virus strain CVS 1.0 IU potency Cooper Expel V04/18.3.3/482 0 Deltamethrin 0.101%m/v Topical: spot grease applicatoin oil spray Ultratet V03/17.1.2/698 0 Oxytetracycline 125mg/ml Count-Down LC V03/16.1/483 0 per 4.5g dose: Ampicillin 75mg; Cloxacillin 200mg Intra-mammary Afrivet Business Management (Pty) Afrivet Business Management (Pty) Afrivet Business Management (Pty) Afrivet Business Management (Pty) Afrivet Business Management (Pty) N-SR /04/2005 N-SR /02/2004 N-SR N-SR Nov-2003 N-SR 1148 Allmycin V93/17.1.2/475 0 Oxytetracycline HCL 12.5%m/v Allvet (Pty) 11-Oct-1993 N-SR 0544 Ivacare V02/18.1.2/707 0 Ivermectin 1.0%m/v Ivacare Pour-On V02/18.1.2/702 0 Ivomec 1.0%m/v Matrix V07/18.3.9/178 0 Matrix Tape Hi Mineral V07/18.1.8/177 0 Abamectin 1g/ml; Levamisole HCL 40g/ml; Oxfendazole 22.7g/ml; Na selenate 952mg/ml; Co EDTA g/ ml Abamectin 1g/ml; Levamisole HCL 40g/ml; Oxfendazole 22.7g/ml; Praziquantel 18.8g/ml;Na selenate 952mg/ml; Co E DTA g/ml Oral: liquid Oral: liquid Animal Health Care South Africa (Pty) Animal Health Care South Africa (Pty) Animal Health Care South Africa (Pty) Animal Health Care South Africa (Pty) Sheep Scab claim only with spesific written application to and approval from the DVS N-SR N-SR /02/ /02/2007 N-SR 1355 N-SR 1356

6 6 Government Gazette 21 September MDB Iver 1% V02/18.1.2/ Ivermectin 1.0%m/v Amigard V04/18.3.4/788 0 Amitraz 12.53%m/m Topical: spray Bodyguard V04/18.3.3/345 0 Flumethrin 1%m/v Acarins V90/18.3.3/463 0 Flumethrin 2%m/v Bayopet Tick and Flea Powder Bayopet Tick and Flea Dog Collar Bayopet Tick and Flea Collar for small Dogs Bayopet Tick and Flea Cat Collar Bayopet Tick and Flea Rinse V88/18.3.4/470 0 Propoxur 1%m/m V88/18.3.4/466 0 Propoxur 9.4%m/m V88/18.3.4/465 0 Propoxur 9.4%m/m V88/18.3.4/464 0 Propoxur 9.4%m/m V88/18.3.3/467 0 Flumethrin 2%m/v Bayopet Spotton V88/18.3.2/469 0 Fenthion-methyl 20%m/v Bayopet Spotton for Cats Drontal V88/18.1.8/471 0 Profender V08/18.1.8/450 0 V88/18.3.2/468 0 Fenthion-methyl 10%m/v Praziquantel 50mg; Fenbental 150mg; Pyrantel embonate 144mg per Oral: tablet Emodepside 21.4mg/ml; Praziquantel 85.8mg/ml Topical: spray / dip Topical: powder application Topical colar slow release substance Topical colar slow release substance Topical colar slow release substance Topical: spray / dip Oral: tablet Animal Health Care South Africa (Pty) Argos Veterinary Science (Pty) Argos Veterinary Science (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Sheep Scab claim only with spesific written application to and approval from the DVS N-SR N-SR /02/2004 N-SR /08/1990 N-SR /06/1995 N-SR /06/1990 N-SR /06/1989 N-SR /06/1988 N-SR /06/1991 N-SR /06/1993 N-SR /06/1992 N-SR /06/1996 N-SR /07/2009 N-SR 1487

7 5042 Government Gazette 21 September Baycox 5% V07/17.4.1/461 0 Toltrazuril 5g/100ml Oral: liquid Hi-Tet 200 LA Gold V07/17.1.2/462 0 Oxytetracycline dihydrate 232.0mg/ml Advantage for Dogs V05/18.3.9/821 0 Imidicloprid 9.1%m/m Advantix for Cats V05/18.3.9/820 0 Imidicloprid 9.1%m/m Advantix for Dogs V05/18.3.9/819 0 Advocate for cats V12/18.2/993 0 Advocate for dogs V12/18.2/992 0 Drontal for small dogs Drontal flavoured for large dogs Drontal Cat XL Oral: tablets V12/18.1.8/991 0 V12/18.1.8/990 0 V12/18.1.8/ Imidicloprid 10g/100ml; Permethrin 50g/100ml Per dose: Imidacloprid 100mg/ml; Moxidectin 10mg/ml Per dose: Imidacloprid 100mg/ml; Moxidectin 25mg/ml Per Oral: tablet: Praziquantel 15mg; Pyrantel Embonate 43.20mg; Febental 75mg; Per Oral: tablet: Praziquantel 175mg; Pyrantel Embonate (Pamoate) 504mg; Febental INN 525mg Praziquantel 30mg; Pyrantel Emboate 345mg Bromnil V01/18.3.8/325 0 Triflumuron 480g/l Zapp V01/18.3.8/324 0 Triflumuron 480g/l Milbitraz WP V01/18.3.4/328 0 Amitraz 23.75%m/v Cylence V01/18.3.3/317 0 Cyfluthrin1%m/v Oral: tablet Oral: tablet Oral: tablet Topical: spray / dip Topical: spray / dip Topical: water soluble powder Brutel V01/18.1/326 0 Praziquantel 3.75%m/v Oral: liquid Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) 23/07/2007 N-SR 1370 N-SR Aug-2007 N-SR N-SR N-SR N-SR N-SR N-SR N-SR N-SR N-SR /03/2001 N-SR /03/2001 N-SR /03/2001 N-SR /03/2001 N-SR /03/2001 N-SR 0897

8 8 Government Gazette 21 September Leviran V01/18.1.8/316 0 Levisan V01/18.1.8/315 0 Rafoxanide 3.0%w/v; Levamisole HCL 3.0%w/v; Levamisole HCL 2.5%m/v; Oxycloxanide 3.4%m/v Milbitraz TR V01/18.1.4/322 0 Amitraz 23.75%m/v Milbitraz Spraydip V01/18.1.4/320 0 Amitraz 12.5% Oral: liquid Oral: liquid Topical: water soluble powder Topical: spray / dip Oxfen C V01/18.1.1/323 0 Oxfendazole 9.06% Oral: liquid Oxfen V01/18.1.1/318 0 Oxfendazole 2.265%m/n Oral: liquid Necrospray NF V01/ /327 0 Oxytetracycline HCL 40mg/g; Gentian Violet 4mg/g Milbitraz LS V01/ /321 0 Amitraz 23.75%m/v Drontal for large Dogs V12/18.1.8/ Drontal Cat V12/18.1.8/ Fenbental INN 525.0mg; Pyrantel Embonate 504.0mg; Praziquantel 175.0mg; Praziquantel 20mg; Pyrantel Pamoate 230mg Topical: spray Topical: water soluble powder Oral: tablet Oral: tablet Baymec V11/18.1.2/ Ivermectin 1%w/v Drastic Deadline Extreme V10/18.3.2/ Quantel V07/18.1.8/443 0 Fluaruzon (technical 974.%) g/100ml; Flumethrin (technical 96%) 1g/100ml; Per oral: tablet: Praziquantel 50mg; Fenbendazole 500mg Oral: tablet Veriben Solution V04/17.4.2/181 0 Diminazene diaceturate 7.0g/100ml. Phenazone 37.5g/100ml Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Bayer Animal Health (Pty) Burke Animal Health (Pty) Ceva Anchorpharm Animal Health SA (Pty) 13/03/2001 N-SR /03/2001 N-SR /03/2001 N-SR /03/2001 N-SR /03/2001 N-SR /03/2001 N-SR /03/2001 N-SR /03/2001 N-SR N-SR N-SR N-SR N-SR /07/2007 N-SR /11/2006 N-SR 1127

9 5042 Government Gazette 21 September Ceva Chlamydia V10/24.4/877 0 Thermosensitive live Chlamydophila abortus strain ts. 1B Tick Grease V99/18.3.3/332 0 Cypermethrin 0.025%m/m Topical: spot grease application Eprecis V11/18.1.2/957 0 Eprinomectin 0.01g/ml Veriben B12 V09/17.4.2/330 0 MDB Abasantel Drench Ceva Vitahep-B V07/19.4/168 0 Ceva VitE-Se V07/19.2/174 0 Ceva Phospho-B V07/19.2/172 0 Ceva Vitagrow V07/19.2/170 0 Dinimazene diaceturate 1.05g; Vit B mg; Vit B12a 2.4mg; / 2.36g sachet : granules for reconstitution V08/18.1.2/329 0 Abamectin 1g/l; Closantel 50.0g/l Oral: liquid Vitamin B1 20mg/ml; Vit. B2 5mg/ml; Vit.B6 10mg/ml; Vit.B12 100mg/ml; Nicotinamide 20mg/ml; Panthotenic acid 5mg/ml; Choline Chloride 2mg/ ml; Liver Extract 60mg/ml Vitamine E acetate 17mg/ml; Naselenate 1.67mg/ml Na glycerophosphate 200mg/ml; Vit B12 50mcg/ml; VitB6 12mg/ml; Pantothenic acid 3mg/ml; Methyl paraben 1mg/ml Vitamin A IU; Vit.D IU; Vit.B1 10mg; Vit.B2 0.04mg; Vit.B6 2mg; Vit B mg; Vit. E 4mg; Ca Panthotenate 2mg; Methionine 5mg; Choline Chloride 2.36mg; Mg Chloride 0.78mg; Co sulphate 0.02mg; Cu sulphate 0.1mg; Zn sulphate 0.1mg; Mn sulphate 0.1mg; Nicotinamide 5mg; Inositol 2mg; Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) N-SR Aug-1999 N-SR N-SR /08/09 N-SR Feb-2008 N-SR /08/ N-SR /03/2007 N-SR /03/2007 N-SR /03/2007 N-SR 1408

10 10 Government Gazette 21 September Ceva B-Forte V07/19.1/171 0 Vitamin B1 50mg/ml; Vit B2 7.5mg/ ml; Vit B6 10mg/ml; Vit B12 100mcg/ml; Nicotinamide 100mg/ml; Pantothenic acid 10mg/ml; Clomectin V07/18.3.9/167 0 Abamectin 1g/l; Closantel 50.0g/l MDB 3+ V07/18.3.9/166 0 MDB 4+ Tape V07/18.3.9/165 0 Cevaprim V07/17.1.7/169 0 Cevatet Spray V07/17.1.2/175 0 Coglavax V06/24.4/180 0 Coglamune V06/24.4/179 0 Abamectin 1g/l; Levamisol HCL 40g/l; Oxfendazole 22.7g/l; Sodium selenate 952mg/l; Cobald EDTA g/l Abamectin 1g/l; Levamisol HCL 40g/l; Oxfendazole 22.7g/l; Praziquantel 18.8g/l; Sodium selenate 952mg/l; Cobald EDTA g/l Sulfamethoxazole 200mg/ ml;trimethoprim 40mg/ml Oxytetracycline HCL 33mg/ml; d-panthenol 50mg/ml; Gentian Violet 6mg/ml Alpha toxoid of C.perfringens type A min.2iu/ml; Beta toxoid of C.perfringens type C min.10iu/ml; Epsilon toxoid of C.perfringens type D min.5iu/ml; Toxoid of C.septicum min.2.5iu.ml; Alpha toxoid of C.novyi type B (oedematiens) min.3.5iu/ ml; Toxoid of C.Tetani min 2.5IU/ ml; Anaculture of C.chauvoei 100% protection in guinea pigs Alpha toxoid of C.perfringens type A 2IU/ml; Beta toxoid of C.perfringens type C 10IU/ml; Epsilon toxoid of C.perfringens type D 5IU/ml Oral: liquid Oral: liquid Topical: Topical: aerosol spray spray Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) Ceva Animal Health (Pty) 26/03/2007 N-SR /04/2009 N-SR /11/2007 N-SR /11/2007 N-SR /03/2007 N-SR /03/2007 N-SR /02/2006 N-SR /01/2007 N-SR 1345

11 5042 Government Gazette 21 September Cevamec 1% injectable solution V01/18.1.2/182 0 Ivermectin 0.01g/ml Supaspray V09/18.3.9/882 0 Nemarox V09/18.1.8/872 0 Endo+Lint V05/19.1.8/289 0 Supatraz 25% Cattle, Sheep & Goat Dip Per 100ml: Dichlorovos 1.60g; Cypermethrin 0.37g; Sulfadiazine 0.11g; Piperonyl butoxide 0.21g Levamisole HCL 25.5g/l; Rafoxanide 25.0g/l Levamisol HCL 37.5mg/l; Praziquantel 18.8mg/l V05/18.4.4/296 0 Amitraz 25%m/v Maxipour V05/18.2.3/287 0 Flumethrin 1%m/v Bantil Cattle Dip V05/18.1.8/290 0 Pegamax V05/18.1.8/285 0 Cymiazole 17.5%m/v; Cypermethrin 2.5%m/v Abamectin 3.7g/kg; Praziquantel 46.2g/kg Topical: spray Oral: liquid Oral: liquid Topical: spray / dip Topical: spray / dip Oral: paste Pegasol V05/18.1.5/286 0 Pyrantel Pamoate g/kg Oral: paste Levamintic Concentrate Ivermax 1% Injectable Solution Ivermax Sheep Drench V05/18.1.4/288 0 Levamisole HCL 25%m/v Oral: liquid V05/18.1.2/293 0 Ivermectin 1%m/v V05/18.1.2/292 0 Ivermectin 0.8mg/ml Oral: liquid Maxitet 13.5% V05/17.1.2/295 0 Oxytetracycline HCL 135mg/ml Maxitet LA V05/17.1.2/294 0 Oxytetracycline HCL 230mg/ml Ceva Animal Health (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) Cipla Agrimed (Pty) 09/08/2001 Sheep Scab claim only with spesific written application to and approval from the DVS N-SR N-SR N-SR 1489; N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR May-2005 N-SR 1270

12 12 Government Gazette 21 September Lactacure LC V05/16.1/291 0 Cloxacillin200mg/4.5 syringe; Ampicillin 75mg/4.5g syringe Oticlear V05/14.1/284 0 Lactic acid 25g/l; Salicylic acid 1g/l; Fiprotec Spray V08/18.3.6/446 0 Fipronil 9.7%w/v Fiprotec Spot-On for Dogs Fiprotec Spot-On for Cats Ivermax + Minerals V08/18.1.8/449 0 Ivermax + AD3E V07/18.1.8/448 0 Pegaforte V07/18.1.8/447 0 Triworm D V06/18.1.8/609 0 Triworm C V06/18.1.8/608 0 Siteguard M2G V91/24.4/524 0 Tascax-PKT V91/24.4/523 0 V08/18.3.6/445 0 Fipronil 9.7%w/v V08/18.3.6/444 0 Fipronil 9.7%w/v Ivermectin 1%m/v; Cu 1,03g; Zn 0.025g; Co 0.064g; Mn 0.898g; Ammonium molibdate 0.092g Per 100ml: Ivermectin 1.1g; Vit A palmitate IU; Vit E acetate 1 000IU; Vit D IU; Ivermectin 12mg/g; Praziquantel 150mg/g Praziquantel 50mg/Tabl.; Pyrantel Pamoate 144mg/Tabl.; Febental 150mg/Tabl. Praziquantel 20mg/Tabl.; Pyrantel Pamoate 230mg/Tabl. Cl.chauvoei 20%v/v toxoid; Cl.septicum 5%v/v toxoid; Cl.haemolyticum(Cl.novyi ttype D) toxoid 10%v/v; Cl.novyi type B 2.5%v/v;Cl.sordellii 7%v/v; Cl.perfringens type C 6%v/v; Cl.perfringens type D 6%v/v Cl.perfringens type D toxoid; alum. hydroxide adjuvant of Cl.tetani Intra-mammary Topical: external ear canal spray Cipla Agrimed (Pty) Cipla Agrimed (Pty) 12-May-2005 N-SR May-2005 N-SR 1261 Cipla Vet (Pty) 9-Feb-2008 N-SR 1472 Cipla Vet (Pty) 9-Feb-2008 N-SR 1473 Cipla Vet (Pty) 9-Feb-2008 N-SR 1474 Cipla Vet (Pty) 7-Sep-2008 N-SR 1377 Cipla Vet (Pty) 7-Sep-2007 N-SR 1376 Oral: paste Cipla Vet (Pty) 17/09/2007 N-SR 1477 Oral: tablet Cipla Vet (Pty) N-SR 1277 Oral: tablet Cipla Vet (Pty) N-SR 1278 Coopers Animal Health (Pty) td 27/06/1991 N-SR 0557 N-SR 1392 Coopers Animal Health (Pty) td 27/06/1991 N-SR 0556

13 5042 Government Gazette 21 September Eyeguard V08/24.4/549 0 Coopercid Spray V07/18.3.9/550 0 Covexin 10 V05/24.4/413 0 Triatix 500 LS Cattle Dip Triatix 500 TR Cattle, Sheep, and Goat Dip Coopers Zero Tick Cattle Dip and Spray Triatix 500 TR Cattle Dip Triatix Cattle Pour- On Coopers Redline Pour-On Deca-Spot 0.5% Pour-On Moraxella bovis strains: EPP 63 13%; FLA 64 13%; SAH 38%; Ethion 2.87%m/m; Cypermethrin 0.57%m/m V05/18.3.4/415 0 Amitraz 500g/kg V05/18.3.4/414 0 Amitraz 500g/kg per dose: C.perfringens type A toxoid 0.5IU; C.perfr.type B toxoid B:10IU+5IU E; C.perf. Type C toxoid 10IUB; C.perfr.type D 5IUE; C.chau- voei whole culture meets Ph.Eur.; C.novyi toxoid. 3.5IU; C.septicum toxoid 2.5IU; C.tetani toxoid 2.5IU; C.sordellii toxoid 1.0U; C.haemolyticum toxoid 10U V04/18.3/551 0 Cyhalothrin 5%m/v V04/18.3.4/558 0 Amitraz 500g/kg V04/18.3.4/557 0 Amitraz 2%m/v V04/18.3.3/556 0 Flumethrin 1%m/v V04/18.3.3/554 0 Deltamethrin 0.5%m/v; Piperonyl Butoxide 2.5%m/v Topical: spray Topical: water soluble powder Topical: water soluble powder Topical: spray / dip Coopermycin 230 LA V04/17.1.2/553 0 Oxytetracycline HCL 230mg/ml Coopermycin 135 V04/17.1.2/552 0 Oxytetracycline135mg/ml Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) 12/ N-SR / N-SR Jun-2005 N-SR Jun-2006 N-SR Jun-2005 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR 1176 ; N-SR 1177

14 14 Government Gazette 21 September Tasvax PK Plus V03/24.4/426 0 C. perfringens toxoid type C & D Rabdomun V03/24.1/ sq.7.3MLD50 inactivated Flury LEP virus strain Grenade V03/18.3/437 0 Cyhalothrin 5%m/v Topical: spray / dip Tramizole V03/18.3.4/427 0 Levamisol HCL 25%m/v Oral: liquid Triatix 250 V03/18.3.4/419 0 Amitraz min. 255g/l Triatix 125 V03/18.3.4/418 0 Amitraz min. 125g/l Clout V03/18.3.3/436 0 Deltamethrin 1%m/v Dec-Spot V03/18.3.3/434 0 Deltamethrin 1%m/v Wipe-Out V03/18.3.3/425 0 Deltamethrin 0.5%m/v Cooperzon 30 V03/18.3.2/435 0 Diazinon 30%m/v Diazinon DFF V03/18.3.2/432 0 Diazinon 88.0%m/v Coopers Supadip V03/18.3.2/416 0 Chlorfenvinphos 300g/kg Ovivax 6 V03/18.1.8/428 0 Tramizan V03/18.1.8/422 0 Levamisole phosphate 6.8%m/v; Toxoids of Cl.perfringens(welchii) type D; Cl.septicum; Cl.tetani; Cl.novyii(oedematiens); Cl. Chauvoei Levamisole HCL 2.5%m/v; Oxycloxanide 3.4%m/v Topical: spray / dip Topical: spray / dip Topical: spray / dip Topical: spray / dip Topical: spray / dip Oral: liquid Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) 5-Jul-2003 N-SR Feb-2003 N-SR 0845 ; N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Nov-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR 0884

15 5042 Government Gazette 21 September Tramisol Plus V03/18.1.8/421 0 Rafoximide 25g/l; Levamisole HCL 25g/l Oral: liquid Tramisol Concentrate V03/18.1.4/420 0 Levamisol HCL 25%m/v Oral: liquid Imizol V03/17.4.2/438 0 Imidocarb dipropionate 12%m/v Sulphamethazine 16% Sulphamethazine 33 1 /3% Hibitane Teat Dip Concentrate V03/17.1.7/424 0 Sulphadimidine sodiun 16%m/v Oral: liquid V03/17.1.7/417 0 Sulphadimidine sodium B.P g/ kg; V03/16.2/429 0 Chlorhexidine gluconate 3.75%m/v Zinc Sulphate V03/13.4/440 0 Zinc sulphate 98.0%m/m Wound Oil V03/13.4/439 0 Dispolac RX4B V03/ /430 0 Triatix Plus Pour-On V04/ /555 0 Dispolac Dry Cow V03/ /431 0 Vegetable oil 33.3%m/v; Oleo resin 58.9%m/v; Germicidal agent 0.5%m/v Procain penicillin 4.87%m/m; Dihydrostreptomycin sulphate 6.5%m/m Amitraz 1.5%m/v; Deltamethrin o,5%m/v Procain penicillin 4.9%m/m; Dihydrostreptomycin sulphate 6.5%m/m Topical: oil emulsion application Intra-mammary Intra-mammary Ecomectin Horse Paste V05/18.1.2/694 0 Ivermectin 18.7g/kg Oral: paste Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Coopers Veterinary Products (Pty) Eco Animal Health Southern Africa (Pty) 5-Jul-2003 N-SR Jul-2003 N-SR Jul-2003 Withdrawal period in tissue 213 days; withdrawal period in milk 6 days N-SR 0868 ; N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR Jul-2003 N-SR 0844 ; N-SR /05/2004 N-SR Jul-2003 N-SR N-SR 1458

16 16 Government Gazette 21 September Ecotraz Plus Pour-On V04/18.3.9/541 0 Amitraz 1.5%m/v; Deltamethrin 0.5%m/v; Piperonyl Butoxide 3.0%m/v EcoBash Cattle Dip V04/18.3.9/535 0 Cymiazole 17%m/v; Cypermethrin 2.5%m/v Topical: spray / dip Ecotraz Cattle Pour- On V04/18.3.4/540 0 Amitraz 2%m/v Eco Delta Pour-On V04/18.3.3/539 0 Deltamethrin 0.51%m/v; Piperonyl Butoxide 2.5%m/v Ecoline Pour-On V04/18.3.3/538 0 Flumethrin 1%m/v Eradiworm V04/18.1.8/542 0 Praziquantel 1.88%m/v; Levamisole HCL 3.75%m/v Oral: liquid Closeco 7.5% Injectable Solution V04/18.1.3/536 0 Sodium Closantel Dihydrate 8.36%m/v Ecofluke V04/18.1.1/537 0 Triclabendazole 10%m/v Ecotraz Pig Pour-On V03/18.3.4/724 0 Amitraz 2%m/v Ecolint Super V03/18.1.3/699 0 Resorantel 25%m/v Oral: liquid Eco Iodine Spray V03/13.2/701 0 Polyvinylpyrrolidone-Iodine 3%m/m Topical: spray Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) 14/05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR /05/2004 N-SR N-SR N-SR N-SR 1086

17 5042 Government Gazette 21 September Eco Copper Sulphate V02/19.3/696 0 Copper sulphate 985m/m Topical: water soluble powder Eco Zinc Sulphate V02/19.3/695 0 Zinc sulphate 98%m/m Topical: water soluble powder Qualitraz 125 V02/18.3.4/709 0 Amitraz 12.5%m/v Topical: dip / spray application Ecosulf LA V02/17.1.7/705 0 Na-sulphadimethoxine 40%m/v Qualisulf LA V02/17.1.7/704 0 Na-sulphadimethoxine 40%m/v Count-Down Teat Dip V02/16.2/703 0 Ecolac Teat Dip V02/16.2/697 0 Per 100ml: Ethyl diamine tetra acetic acid 0.2ml; Na-lauryl ether sulphate 25gm; Formaldehyde sol. 0.1ml; Chlorhexidine gluconate 0.75%m/v; Glucitol 5.0%m/v; Lanolin 0.1%m/v; Vitamin E 0.05%m/v teat application Qualimectin Sheep Drench V00/18.1.2/708 0 Ivermectin 8mg/ml Oral: liquid Zipanver V99/18.1.3/304 0 Closantel 15%m/v Ecomectin Sheep Drench V99/18.1.2/305 0 Ivermectin 0.8%mg/ml Oral: liquid Oxytet FG 200 V95/17.1.2/306 0 Oxytetracycline 200g/kg Oral: premix powder Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) N-SR N-SR 1092 N-SR N-SR N-SR N-SR N-SR N-SR N-SR /09/1999 N-SR /09/1999 N-SR /03/1995 N-SR 0537

18 18 Government Gazette 21 September Ecotraz 25% V04/18.3.4/300 0 Amitraz 25%m/v Topical: spray / dip Leveco Concentrate V04/18.1.4/298 0 Levamisole HCL 25%m/v Oral: liquid Ecomectin Cattle Pour-On V04/18.1.2/299 0 Ivermectin 0.5%w/v Ecomycin Dual Purpose V04/17.1.2/297 0 Oxytetracycline HCL 135mg/ml Ecotel 2.5% V03/18.1/303 0 Praziquantel 2.5%m/v Oral: liquid Eraditape V03/18.1/302 0 Praziquantel 3.75%m/v Oral: liquid Leveco 2.5% V03/18.1.4/301 0 Levamisole HCL 2,5%m/v Oral: liquid Qualitraz 250 V01/18.3.4/310 0 Amitraz 25%m/v Topical: spray / dip Qualifen V01/18.1.3/309 0 Fenbendazole 5%m/v Oral: liquid Ecolint V01/18.1.3/308 0 Niclosamide 20% m/v; Oral: liquid Ecomycin LA V01/18.1.2/307 0 Oxytetracycline HCL 230mg/ml Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) 24/02/2004 N-SR /02/2004 N-SR /02/2004 N-SR /02/2004 N-SR Jan-2003 N-SR Dec-2003 N-SR Nov-2003 N-SR /06/2001 N-SR /06/2001 N-SR /06/2001 N-SR /04/2001 N-SR 0922

19 5042 Government Gazette 21 September Ostridose V01/18.1.1/312 0 Fenbendazole 5%m/v Oral: liquid Aivlosin FG 50; V01/17.1.4/311 0 Eco Afterbirth Pessaries V03/ /700 0 Acetyl-Isovaleryl-Tylosin tartrate 50g/ kg Per pessary: Oxytetracycline 375mg; Sulphadimidine 125mg; Sulphadiazine 125mg; Sulpha-thiozole 125mg; Cetrimide 10mg Oral: premix powder Intra-uterine pessaries Extinosad V09/29/202 0 Spinosad 2.7%w/v Topical: spray Langa Oral: tablets for Sheep and Goats V02/18.1.2/203 0 Abamectin 0.8%m/m Oral: tablet Diamond VXPC V10/24.5/ Saccharomyces cerevisiae Oral: premix Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Eco Animal Health Southern Africa (Pty) Elanco Animal Health, Devision of Eli Lilly (SA) (Pty) Elangeni Animal Health (Pty) Essential Nutrient Systems (Pty) 15/06/ /06/2001 Not to be used in ostriches nor prescribed animals in terms of Prevention of Undesirable Residue in Meat Act (Act 21 of 1991) N-SR 0921 & N-SR 0917 N-SR N-SR /11/2009 appied 16/02/2002 N-SR 1492 N-SR N-SR Crede-Mintic-Eximec V01/18.1.2/693 0 Ivermectin 1.0%m/v Experto Vet C.C N-SR 0970 Crede-Ecto-Imatraz V08/18.3.4/224 0 Amitraz 250g/m Crede-Mintic- Roxilev NF V08/18.3.9/228 0 Crede-Ecto-Cymatraz V08/18.3.4/231 0 Rafoxanide 2.25%m/v; Levamisole HCL 2.25%m/v Amitraz 250.0g/l; Cypermethrin 70.0g/l Crede-Ecto-Tracypor V08/18.3.4/227 0 Amitraz 17.5g/l; Cypermethrin 15.0g/l Crede-Exto-Cymetrin V08/18.3.3/225 0 Cypermethrin 200g/l Topical: spray / dip Experto Vet C.C. 24/07/2008 Oral: liquid Experto Vet CC 8-Jun-2008 Topical: spray / dip Topical: spray / dip Experto Vet CC 8-Apr-2008 Experto Vet CC 8-Jun-2008 Experto Vet CC 24/07/2008 N-SR 1470 N-SR 0975 N-SR 1466 N-SR 0969 N-SR 1463 N-SR 0973 N-SR 1467 N-SR 0977 N-SR 1469 N-SR 0974

20 20 Government Gazette 21 September Crede-Ecto-Perthrin V08/18.3.3/223 0 Cypermethrin 90 % Crede-Mintic- Ziprate; Crede-Mintic-Eximec Injectable Crede-Mintic- Elbezole 10% Topical: spray wipe on Experto Vet CC 24/07/2008 N-SR 1471 N-SR 0977 V08/18.1.3/229 0 Praziquantel 25g/l Oral: liquid Experto Vet CC 8-Jun-2008 N-SR 1465 V08/18.1.2/230 0 Ivermectin 10g/l Experto Vet CC 8-Jun-2008 N-SR 1464 V08/18.1.1/226 0 Albendazole 10% Oral: liquid Experto Vet CC 8-Jun-2008 Crede-Bab-Minazene V08/17.4.2/232 0 Diminazene diaceturate 1.05g Experto Vet CC 8-Jun-2008 Vit-Aid Vitamin A Salcostat plus V97/25.1/600 0 Suvaxyn MaternaFend 4 V02/19.1/472 0 Vit A IU/ml; Vit E 50IU/ml V97/24.5/839 0 HerdFend Thrix V97/24.5/598 0 Vaxall 6 V97/24.4/863 0 Vaxall 8 V97/24.4/862 0 Dinitolmide 25%m/m; Ethopabate 1.6%m/m E.coli antigen strain K μg/ml; E.coli antigen strain K μg/ml; E.coli antigen strain 987-P 275.5μg/ml; E.coli antigen strain F μg/ml Erysipelothrix Rhusiopathiae, inactivated selected strains Cl.perfringens type D toxoid; Cl.septicum toxoid; Cl.novyi type B toxoid; Cl.tetani toxoid; C.Pseudotuberculosis (ovis); Cl.chauvoei anaculture Cl.perfringens type C toxoid; Cl.perfringens type D toxoid; Cl.septicum toxoid; Cl.novyi type B toxoid; Cl.tetani toxoid; Cl.chauvoei anaculture Oral: premix powder Formulation Technologies CC Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) N-SR 1468 N-R 0971 N-SR 1462 N-SR May-2002 N-SR Nov-1997 N-SR N-SR Nov-1997 N-SR N-SR N-SR 0735

21 5042 Government Gazette 21 September Pyramid 4 V97/24.4/860 0 Triangle 4 + PH-K V97/24.4/840 0 Per dose: freeze-dried mod. live BVD virus 10sq.4.7 TCID 50; mod.live IBR virus 10sq.4.3 TCID; mod.live BRSVvirus 10sq.5.3 TCID; mod.live PI3 virus 10sq.4.6 TCID; Inact.BVD virus antigen R.P 1.2; inct. IBR virus antigen R.P 1.8; inct.brs virus antigen R.P 1.0; inact. PI3 virus antigen R.P 1.2; Bursine-2 V97/24.3/857 0 Intermediate live modified infect.bursal disease Coryza Vac V97/24.3/602 0 Haemophilis gallinarium bacterin, selected strains IBMM V97/24.3/597 0 Infectious bronchitis live virus strain Massachusetts Pampass Original V97/18.3/852 0 Flufenoxuron 10%m/v Sunitik V97/18.3/846 0 Fenvalerte (sumicidine technical 93%) 217g/l Protaid V97/18.3.9/861 0 Supona Tick and Maggot Surface Topical: aerosol spray V97/18.3.9/847 0 Chlorfenvinphos (techical 91.1%) 329g/l; Alphacypermethrin (100%) 30g/l Chlorfenvinphos 0.48%m/v; Dichlorvos 0.74%m/v; Gentian Violet 0.145%m/v water soluble drinking water water soluble occular drop or nasal drop or Topical: aerosol spray spray or drinking water Topical: dip / spray application Topical: dip / spray application Topical: dip / spray application Topical: spray Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) N-SR N-SR N-SR Nov-1997 N-SR Nov-1997 N-SR N-SR N-SR N-SR N-SR 0740

22 22 Government Gazette 21 September Renegade V97/18.3.3/851 0 Alphacypermethrin 15g/l Definace V97/18.3.2/855 0 Chlorfenvinphos 0.08%m/v Topical: dip application spray Sumiplus V97/18.3.2/850 0 Chlorfenvinphos 30.0%m/v; Esfenvalerate 2.2%m/v Topical: dip / spray application Supona 30 V97/18.3.2/844 0 Chlosfenvinphos (93% kg/l Supona Angora Goat Dip V97/18.3.2/835 0 Chlorfenvinphos(93% g/l; Diasidip 30 V97/18.3.2/599 0 Diazinon 315,8%g/l Vetdectin Weanerguard V97/18.1.8/596 0 Vetdectin Eweguard V97/18.1.8/593 0 Moxidectin 0.25%; antigens %m/v of Cl.perfringens type D 1.3; Cl.chauvoei 1.5; Cl.septicum0.6; Cl.novyi type B 0.7; Cl.tetani 0.15; Corynebacterium pseudotuber- culosis-ovis 0.3; Moxidectin 0.5%; antigens %m/v of Cl.perfringens type D 1.35; Cl.chauvoei 1.5; Cl.septicum0.6; Cl.novyi type B 0.7; Cl.tetani 0.15; Corynebacterium pseudotuber- culosis-ovis 0.3; Topical: dip / spray application Topical: dip / spray application Topical: spray / dip Atgard Pig Wormer V97/18.1.7/858 0 Dichlorvos 180g/kg; Oral: granules Equiguard Horse Wormer Cydectin 0.2% Oral Solution V97/18.1.7/853 0 Dichlorvos 19.5%m/m Oral: granules V97/18.1.2/856 0 Moxidectin 0.21%m/v Oral: liquid Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) N-SR N-SR Sheep Scab claim only with spesific written application to and approval from the DVS N-SR N-SR N-SR Nov-1997 N-SR Nov-1997 Sheep Scab claim only with spesific written application and permissiion to/ from the DVS N-SR Nov-1997 Sheep Scab claim only with spesific written application to and approval from the DVS N-SR 0734; N-SR N-SR N-SR N-SR 0749

23 5042 Government Gazette 21 September Equest Gel V97/18.1.2/854 0 Moxidectin 20%g/kg Oral: gel Cydectin Injectable V97/18.1.2/845 0 Moxidectin 1.050%m/v; Coli-Rid Oral V97/17.1.7/859 0 Webster s Bovine Ephemoral Fever Vaccine V09/24.4/692 0 Rabvac 3 TF83 V09/24.1/691 0 Cydectin Weanerguard with Selenium and Vitamin B12 V09/18.1.8/880 0 TrichGuard V5L V06/24.4/585 0 Na-sulfachlorpyridazine 100mg / ml; Trimethoprim 20mg/ml; Phenoxyethanol 6mg/ml Live Bovine Ephemoral Fever virus (titre 10sq.4.3TCID50) Inact. Rabies viral fluid antigen 10sq.6.3 FAID50/ml Moxidectin 0.25%m/v; antigens of :Cl.perfringens type D; Cl.chauvoei; Cl.septicum; Cl.novyi type B; Cl.tetani; Coryne-bacterium pseudotuberculosisovis; Se 0.5mg/ml; Vit.B12 per dose: Trichomonas Foetus 5.0x10sq.7 organisms/5ml/; Campylobacter foetus strain1 4.43x10sq.10org.; C.foetus strain x10sq.10org.; C.foetus strain3 4.76x10sq.10org.; Leptospira canicola 3.95x10sq.8org.; L.grippotyphosa 3.4x10sq.8org,; L.hardjo 3.95x10sq.8org.; L.icterohaemorrhagiae 3.95sq.8org.; L.pomona 3.40x10sq.8org. ProMeris for Cats V06/18.3/544 0 Metaflumizone 204.0g/l Oral: water soluble powder Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) N-SR Sheep Scab claim only with spesific written application to and approval from the DVS N-SR N-SR N-SR N-SR N-SR Nov-2006 N-SR 1284; N-SR /11/2006 N-SR 1344

24 24 Government Gazette 21 September Promeris Duo for Dogs EquiVac EHV-1 / 4 V04/24.6/547 0 V06/18.3.9/543 0 Metaflumizone 15.3g/; Amitraz 15.3g/l EHVStrain (EHV-1)antigen 7.4dose equiv./ml; EHVstrain (EHV-4) antigen 9.8dose equiv./ml Defiance Topical: aerosol spray V04/18.3.2/591 0 Chlorfenvinphos 2.5g/l; Cresylic acid 25g/l Topical: aerosol spray Cydectin Se Oral Drench Cydectin plus Tape Oral Drench Cydectin LA Injectable for Sheep V04/18.1.8/548 0 V04/18.1.8/545 0 Trichguard V03/24.4/588 0 Cydectin Eweguard+Se and B12 Moxidetin 3.359g/kg; Sodium Selenate 20.0g/kg Moxidectin g/l; Praziquantel g/l; Oral: liquid Oral: liquid V04/18.1.2/546 0 Moxidectin 2.0%m/v V03/18.1.8/589 0 Cydectin plus Fluke V03/18.1.8/587 0 Equest Plus Tape V03/18.1.8/586 0 Cydectin LA Injectable for Cattle Tritrichomonas foetus 5.0x10sq.7org./2ml dose Moxidectin 5mg/ml; Sodium selenate 1mg/ml; Hydroxocobalamin 1mg/ml Moxidectin 3.45g/kg; Triclabendazole 52.5g/kg Moxidectin 2.16g/kg; Praziquantel 12.17g/kg Oral: liquid Oral: paste V03/18.1.2/590 0 Moxidectin 10%m/v Avatec V02/25.1/848 0 Lasalocid Sodium 150.0mg/g Oral: premix Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) 30/11/2006 N-SR Oct-2004 N-SR Dec-2004 N-SR 1133; N-SR 1223; N-SR Oct-2004 N-SR Oct-2004 N-SR Oct-2004 N-SR /06/2003 N-SR /06/2003 N-SR 1734; N-SR 1223 ; N-SR /06/2003 N-SR /06/2003 N-SR /06/2003 N-SR N-SR 1022

25 5042 Government Gazette 21 September ND La Sota V01/24/3/583 0 Suvaxyn AR/T/E V01/24.5/582 0 Suvaxyn P V01/24.5/581 0 Suvaxyn PLE + B V01/24.4/595 0 Pneumabort-K + 1b V01/24.4/592 0 Suvaxyn L V01/24.4/579 0 Virol fluids 10sq.6.0EID50/0.03ml dose per 2ml dose: Bordetella bronchiseptica ml; Pasteurella multicida sero type D 0.1ml; Erysipelothrix rhussiopathie 0.5ml; per 2ml dose: Porcine parvovirus 0.169ml per dose: Porcine Parvovirus strain NADL-2 1.7X10sq.7TCID50; Erysipelothrix rhusiopathiae strain CN %PCV; Leptospira canicola strain LC-NY 8.0x10sq.8; L.pomona strain LP x10sq.8; L.icterohaemorrhagiae strain LI x10sq.9; L.grippotyphosa strain LG-F x10sq.8; L.hardjo strain LH-SB1 1.4x10sq.9; L.bratislava LB lowa B2a 1.0x10sq.9; Per 2ml dose: EHV-1p (A-183) ml; EHV-1b (T-480) ml per 2ml dose: Leptospira canicola0.334ml; L.hardjo 0.4ml; L.pomona 0.286ml; L.grippotyphosa ml; L.icterohaemorrhagica 0.286ml; water soluble occular drop or nasal drop or Topical: aerosol spray spray or drinking water Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) 15/06/2001 N-SR /06/2001 N-SR 0944 & N-SR /06/2001 N-SR Sep-2001 N-SR /06/2001 N-SR /04/2001 N-SR 0941

26 26 Government Gazette 21 September Pyramid 4 + Presponse SQ Columbovac/ PMVPox Colombovac Paratyphus V01/24.4/577 0 V01/24.3/584 0 V01/24.3/576 0 Rabvac 3 V01/24.1/580 0 Cydectin Antiparasitic Pour- On Cydectin 0.1% oral Solution Fel-O-Vax Lv-K*IV V97/24.2/897 2 Duramune DA2PP + CvK/LCI Fel-O-Vax LV-K lv+ Calicivax (live) modified live /dose: BVD virus 10sq.5.6TCID50; BHV10sq.4.8 TCID50; BRSV10sq.5.2TCID50; PI3 10sq.6.8 TCID50; as diuent P.haemolytoca neutralised toxoid per 0.2ml dose: Pidgeon Pox virus strain DD 10sq.3.5TCID50; New Castle Diseas virus 1-sq.9.0EID50 Salmonella typhimurium var. Copenhagen inact.liquid 5x10sq.7CFU/ dose per 1ml dose: inact.rabies fluid ml V01/18.1.2/594 0 Moxidectin 5mg/ml V01/18.1.2/578 0 Moxidectin 0.355m/v Oral: liquid V97/24.1/995 2 V09/24.2/943 2 Per 1ml dose inact.: FeLVvirus 0.5ml; FPVvirus 0.08ml; FCVvirus 0.06ML; FVR 0.15ml; FCP stock 0.03ml Freeze-dried mod. live: Canine Distemper virus; Canine Adenovirus type 2; Canine Parainfluenza virus; Canine Parvo virus stain KF-11 inact. Canine Corona virus; Leptospira canicola bacteria; L.Icterohaemorrhagiae bacteria; Per 1ml antigen dose: Feline Viral Rhinotracheitis R.P. 1; Feline Calici strain 255 R.P. 1; Feline Calici strain DD! R.P.1; Feline Panleukopaenia R.P. 1; Feline Leukaemia R.P. 1; Feline Chlamydophila felis R.P. 1; Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) 15/06/2001 N-SR 0931; N-SR /06/2001 N-SR /06/2001 N-SR /06/2001 N-SR /04/2001 N-SR /06/2001 N-SR N-SR N-SR N-SR 0728

27 5042 Government Gazette 21 September Fel-O-Vax PCT + Calicivax (live) V09/24.2/942 2 Fel-O-Guard Plus 4+LvK V07/24.2/952 2 LeptoVax 4/C V07/24.1/955 2 Duramune Adult C4 V07/24.1/954 2 Duramune Adult C3 V07/24.1/953 2 Fel-O-Vax FIV V03/24.2/945 2 Per 1ml antigen dose: Feline Viral Rhinotracheitis R.P. 1; Feline Calici strain 255 R.P. 1; Feline Calici strain DD! R.P.1; Feline Panleukopaenia R.P. 1; Per ml dose:feline Rhinotracheitis virus >10sq.7.5 TCID50; Fe Calici virus 10sq.73 TCID50; Fe Chlamydia psittaci 2 dose equiv.; Fe Leukaemia virus 33.3 dose equiv.; Titre/dose (ml/ml) antigen: Canine Corona virus 0.15; Leptospira canicola ; L. icterohaemorrhagiae ; L.grippo-typhosa 0.022; L.pomona 0.022; Canine Distemper virus 10sq.2.46 TCID50; Ca Adeno virus type 2 10sq.4.8 TCID50; Ca Parainfluenza virus 10sq.4.55 TCID50; Ca Parvo virus 10sq.4.8 TCID50; Canine Distemper virus 10sq.2.46 TCID50; Ca Adeno virus type 2 10sq.4.8 TCID50; Ca Parvo virus 10sq.4.8 TCID50; Feline Immunodeficiency virus strain Petaluma 2.5dose equiv./ml; Fel. Immunodef.virus strain Shizuoka 1.0dose equiv./ml Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) N-SR N-SR N-SR 1351 ; N-SR N-SR N-SR N-SR 1096

28 28 Government Gazette 21 September Duramune Max 5-CvK/4L V03/24.1/951 2 Duramune Max 5/4L V03/24.1/950 2 Duramune Max 5-CvK V03/24.1/949 2 Per dose mod.live: Canine Distemper virus stock >10sq.3.7 TCID50; Ca Adeno virus stock type 2 >10sq.4.8 TCID50; Ca Parainflu-enza virus stock >10sq.5.8 TCID50; Ca Parvo virus stock strain FD 99 & 2b >10sq.5.6 TCID50; inact.ca Corona virus conc.>rp-10sq.1.0 TCID50; Leptospira canicola ml(ART sat); L.icterohae-morrhagiae ml (ART sat); L.grippityphosa 0.022ml (ART sat); L.pamoa ml (ART sat) Per dose mod.live: Canine Distemper virus stock >10sq.3.7 TCID50; Ca Adeno virus stock type 2 >10sq.4.8 TCID50; Ca Parainflu-enza virus stock >10sq.5.8 TCID50; Ca Parvo virus stock strain FD 99 & 2b >10sq.5.6 TCID50; Leptospira canicola ml(ART sat); L.icterohaemorrhagiae ml (ART sat); L.grippityphosa 0.022ml (ART sat); L.pamoa ml (ART sat) Per dose mod.live: Canine Distemper virus stock >10sq.3.7 TCID50; Ca Adeno virus stock type 2 >10sq.4.8 TCID50; Ca Parainflu-enza virus stock >10sq.5.8 TCID50; Ca Parvo virus stock strain FD 99 & 2b >10sq.5.6TCID50; inact.ca Corona virus conc.>rp-10sq.1.0 TCID50 Health (Pty) Health (Pty) Health (Pty) N-SR 1106 N-SR 1105 N-SR 1104

29 5042 Government Gazette 21 September Duramune Max 5 V03/24.1/948 2 Duramine Max PC V03/24.1/947 2 Duramine Max Pv V03/24.1/946 2 Fel-O-Vax IV V01/24.2/994 2 Fel-O-Vax lv+ Calicivax (live) V01/24.2/944 2 Duramune* DA2LP + Pv (=Duramune* 6) V01/24.1/999 2 Duramune* KF-11 V01/24.1/998 2 Duramune* DA2PP + CvK (Duramune* 7) V01/24.1/997 2 Per dose mod.live: Canine Distemper virus stock >10sq.3.7 TCID50; Ca Adeno virus stock type 2 >10sq/4.8 TCID50; Ca Parainflu-enza virus stock >10sq.5.8 TCID50; Ca Parvo virus stoxk strain FD 99 & 2b >10sq.5.6TCID50 Canine Parvo virus >4.0dose equiv./ml; inact.canine Corona virus 10sq.5.6 TCID50/ml ml Canine Parvo virus strain FD 99 & 2b 10sq.5.6 TCID50/ml Per 1ml dose inactivated.:fpvvirus 0.05ml; FCVvirus 0.1ml; FVR virus 0.25ml; FPN virus 0.2ml; Per 1ml antigen dose: Feline Viral Rhinotracheitis R.P. 1; Feline Calici strain 255 R.P. 1; Feline Calici strain DD! R.P.1; Feline Panleukopaenia strain Cu-4 R.P. 1; Feline Chlamydophila felis Cello R.P. 1; Freeze-dried modified live: CDVvirus (2.5 FAID50); CAV-2 virus (2.9 TCID50); CPI virus (4.5 FAID50); CPVvirus (4.7 FAID50); Modified live: CDVvirus (2.5 FAID50); CAV-2 virus (2.9 TCID50); CPI virus (4.5 FAID50); CPVvirus (4.7 FAID50); Freeze-dried modified live: CDVvirus (2.5 FAID50); CAV-2 virus (2.9 TCID50); CPI virus (4.5 FAID50); CPVvirus (4.7 FAID50); Inact. CCVvirus ml; Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) Health (Pty) N-SR N-SR N-SR N-SR N-SR N-SR N-SR N-SR 0940

30 30 Government Gazette 21 September Duramune* DA2P + Pv (Duramune* 5) V01/24.1/996 2 Duramune PC V01/24.1/941 2 Tripple Sulpha V97/ /601 0 Friskies Pro-Control Fly Repellent for Dogs and Puppies Friskies Pro-Control Tick and Flea Powder for Dogs and Puppies Friskies Pro-Control Tick and Flea Dip for Dogs and Puppies Friskies/Lopis Tick & Flea Shampoo for Dogs & Puppies Friskies Pro-Control Bird and Pidgeon Topical: aerosol spray Friskies/Lopis Flea & Tick Shampoo for Cats & Kittens Modified live: CDVvirus (2.5 FAID50); CAV-2 virus (2.9 TCID50); CPI virus (4.5 FAID50); CPVvirus (4.7 FAID50); Per 1ml dose: Canine Corona virus fluids ml; Ca Parvo virus fluids ml Na-Sulphamerazine 27.2%m/m; Na-Sulphathiazole 29.85%m/m; Na- Sulphadimidine 27.2%m/m; Ca-lactate 0.5%m/m; MgSO4 0.25%m/m; KCL 1.51%m/n; NaCL 1.51%m/m; Vit A IU/g 0.69%m/n; Vit D IU/g 0.348%m/m; Oral: water soluble powder V98/18.3.4/243 0 Cypermethrin g/l Topical: spray V98/18.3.4/241 0 Cypermethrin 0.2%m/m V98/18.3.4/239 0 Cypermethrin g/l V98/18.3.4/237 0 Cypermethrin g/l V98/18.3.4/236 0 Cypermethrin 0.222mg/g V98/18.3.4/235 0 Cypermethrin g/l Topical: powder application Topical: Topical: aerosol spray spray Health (Pty) Health (Pty) Health (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) N-SR N-SR Nov-1997 N-SR /06/1998 N-SR /06/1998 N-SR 0769, N-SR 0763 ; N-SR /06/1998 N-SR Jul-1998 N-SR Jul-1998 N-SR /06/1998 N-SR 0769

31 5042 Government Gazette 21 September Friskies/Lopis Flea & Tick Dip for Cats & Kittens Friskies/Lopis Flea & Tick Powder for Cats & Kittens Friskies Dog Tick and Flea Collar Friskies Cat Tick and Flea Collar Friskies Cat Tick and Fleas Topical: aerosol spray Friskies Dog Tick and Fleas Topical: aerosol spray F10SCXD Veterinaty Disinfectant F10CL General Farm Disinfectant F10 Disinfectant Teat Spray with Glycerine and Lanoline F10 Wound Spray with Insecticide F10 Germicidal Treatment Shampoo V98/18.3.4/234 0 Cypermethrin g/l V98/18.3.4/233 0 Cypermethrin 0.2%m/m Topical: powder application V98/18.3.2/244 0 V98/18.3.2/242 0 O-Iso Propoxyphenol Methyl Carbamate 9.4%m/m O-Iso-Propoxyphenyl Methyl Carbamate 9.4%m/m Topical: collar application Topical: collar application V98/18.3.2/240 0 Dichlorvos 2.00g; Fenitrothion 8.00g/l Topical: spray V98/18.1.7/238 0 Dichlorvos 2.00g; Fenitrothion 8.00g/l Topical: spray V11/29/ V11/29/ V11/16.2/ V11/13.2/ V11/13.2/ Benzalkonium chloride 54g/l; Poly(hexamethylene biguanide) hydrochloride 4.0g/l Benzalkonium chloride 10.8g/l; Poly(hexamethylene) biguanide hydrochloride 0.8g/l Benzalkonium chloride 4.5g/l; Poly(hexamethylene) biguanide hydrochloride 0.3g/l Benzalkonium chloride 4.5g/kg; Poly(hexamethylene) biguanide hydrochloride 0.3g/kg; Cypermethrin 2.5g/kg Benzalkonium chloride 4.5g/l; Poly(hexamethylene) biguanide hydrochloride 0.3g/l; Topical: surface liquid application Topical: surface liquid application Topical: udder spray Topical: spray Topical: shampoo Friskies Petcare (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) Friskies Petcare (Pty) Health & Hygiene (Pty) Health & Hygiene (Pty) Health & Hygiene (Pty) Health & Hygiene (Pty) Health & Hygiene (Pty) 29/06/1998 N-SR Jul-1998 N-SR /06/1998 N-SR /06/1998 N-SR /06/1998 N-SR /06/1998 N-SR N-SR N-SR N-SR N-SR N-SR 1546