Home SmPC/PI/PIL Repository

SmPC/PI/PIL Repository

Browse and download official SmPC, PI, and PIL documents

Registration number Active Pharmaceutical Ingredient Brand Name Market Authorization Holder Dosage form Strength PI PIL
BOT2600049 Ceftriaxone sodium Sanaxone 2000 Sance Laboratories PVT. LTD. VI/51B, P.B.No: 2, Kozhuvanal, Pala, Kottayam District, Kerala – 686573, India Powder for Injection 2000mg Download
BOT2600041 Sufentanil Citrate SUFENTA PIRAMAL CRITICAL CARE SOUTH AFRICA (PTY) LTD Office 2, Ground Floor, Kiepersol House, Stonemill Office Park, 300 Acacia Road, Darrenwood, 2194 South Africa Injection 0,005MG/ML, 2MLS Download
BOT2600017 Cetirizine XETEC Cospharm Investments (Pty) Ltd Unit 1, Plot 20705 Block 3 Industrial, Gaborone Botswana Tablets 10 mg Download
BOT2600047 Ibuprofen ADCO-IBUPROFEN ADCOCK INGRAM LIMITED. 1 New Road, Erand Gardens, Midrand, Johannesburg, 1685, Republic of South Africa Tablets 400 mg Download
BOT2600052 Ibuprofen BETAGESIC ADCOCK INGRAM LIMITED. 1 New Road, Erand Gardens, Midrand, Johannesburg, 1685, Republic of South Africa Tablets 200 mg Download
BOT2600042/ BOT2600050 Cefotaxime Sodium USP SANOTAX Sance Laboratories Pvt. Ltd., VI/51B, P.B. No: 2, Kozhuvanal, Pala, Kottayam District, Kerala – 686573, India Dry powder for Injectio 500 mg/1000 mg Download
BOT2600046 Dextromethorphan COFSYL DRY SYRUP Cospharm Investments Pty Ltd. No. 2 Concourse Crescent Lonehill, Johannesburg 2191 South Africa Syrup 15 mg / 5 ml Download
BOT2600012 Acetaminophen/Caffeine ACETAMINOPHEN CAPSULES 500MG AND CAFFEINE 65MG Cospharm Investments Pty Ltd. No. 2 Concourse Crescent Lonehill, Johannesburg 2191 South Africa Soft Gelatin capsules 500 mg and 65 mg Download
BOT2600028 Amoxicillin Trihydrate BP and Diluted Potassium Clavulanate BP RAPICLAV Cospharm Investments (Pty) Ltd No. 2 Concourse Crescent Lonehill, Johannesburg 2191 South Africa Suspension 125mg and 31.25 mg Download
BOT2600025/
BOT2600029
Pregabalin PREGABALIN DENK DENK PHARMA GmbH & Co. KG Prinzregentenstr. 79 81675 München Germany Tablets 75 mg/150 mg Download
BOT2600026 Ranolazine NIZACARD Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018. Telangana state, India Tablets 1000 mg /500 mg Download
BOT2600010/
BOT2600023/
BOT2600027/
BOT2600036
Dasatinib Monohydrate DASATINIB TEVA Teva Pharmaceuticals (Pty) Ltd. 1st Floor, Building 3, Maxwell Office Park, Magwa Crescent West, Waterfall City, Midrand, Gauteng, South Africa Film-coated tablets 20 mg, 50 mg, 70 mg and 100 mg Download
BOT2600018 Paracetamol PARACETAMOL BIOTECH IV Biotech Laboratories (Pty) Ltd Ground Floor, Block K West, Central Park 400 16th Road, Randjespark, Midrand, 1685, South Africa Solution for infusion 10mg/ml Download
Botswana Medicines Regulatory Authority
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