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 |
|---|---|---|---|---|---|---|---|
| BOT2600106_110 | DOXORUBUCIN | RUBIDOKS | Innovata Pharmaceuticals Pty Ltd 100 Northern Parkway, Crownwood Office Park, Ormonde 2091 Johannesburg, South Africa | 2mg/ml concentrate for intravenous infusion | 2mg/ml | Download | |
| BOT2600100 | DIGOXIN | LANOXIN | Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive, Woodmead, Sandton, 2191 South Africa | 0.05mg/ml Oral Elixer | 0.05mg/ml | Download | |
| BOT2600103 | LABETOLOL | TRANDATE | Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive, Woodmead, Sandton, 2191 South Africa | 5mg/ml solution for intravenous injection | 5mg/ml | Download | |
| BOT2600099 | SODIUM CHLORIDE , POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE/ ANHYDROUS | MAINTENANCE SOLUTION FRESENIUS | Fresenius Kabi Manufacturing SA (Pty) Limited 6 Gibaud Road, Korsten Gqeberha, South Africa | 1,5198 g, 1,938 g, 50/55g per 1000ml Intravenous solution for infusion | 1,5198 g, 1,938 g, 50/55g | Download | |
| ABIRATERONE ACETATE | ZYTIGA | JANSSEN PHARMACEUTICA (PTY) LTD 2 Medical Road, Halfway House, Midrand, 1685 | 500 MG FC TABLET | 500 MG | Download | ||
| BOT2600094 | METRONIDAZOLE | Metronidazole 500 mg/100 mL Fresenius | Fresenius Kabi Manufacturing SA (Pty) Limited Business Address: 6 Gibaud Road, Korsten 6020, Gqeberha, South Africa | 500 mg per 100 mL solution for infusion | 500 mg | Download | |
| BOT2600088-89 | PNEUMOCOCCAL MONOVALENT BULK CONJUGATE | PNEUBEVAX 14 | COSPHARM INVESTMENTS (PTY) LTD No. 2 Concourse Crescent Lonehill, Johannesburg 2191 South Africa | (Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) Suspension for Intramuscular Injection | (Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) | Download | |
| BOT2600102 | CLOBETASOL PROPIONATE, MICONAZOLE NITRATE & GENTAMICIN SULPHATE | TASOL GM CREAM | CENTAUR PHARMACEUTICALS Pvt. Ltd. Centaur House, Near Grand Hyatt, Shanti Nagar, Vakola, Santacruz (E), Mumbai 400 055, India | 0.05% w/w / 2% w/w/ 0.1% w/w cream | 0.05% w/w / 2% w/w/ 0.1% w/w | Download | |
| BOT2600101 | CEFPODOXIME PROXETIL | SANDOX-DS 40 | M/s Sance Laboratories Pvt.LTD VI/51B,P.B No.2,Kozhuvanal,Pala Kottayam, Kerala- 686573 India | 40mg/5ml Oral Suspension | 40mg/5ml | Download | |
| BOT2600129 | Lignocaine hydrochloride | AXCEL LIGNOCAINE 2% GEL STERILE | Premier Pharma Trade (Pty.) Ltd. Plot 22122, Nyamambisi Road, Gaborone West Industrial Sites, Gaborone, Botswana | 2% w/w sterile gel | 2% w/w | Download | |
| 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 |