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 |
|---|---|---|---|---|---|---|---|
|
BOT2600180 BOT2600207 BOT2600206 |
RIVAROXABAN | ROXABAN DENK |
DENK PHARMA GmbH & Co. KG Prinzregentenstr. 79 81675 München Germany |
FILM-COATED TABLETS | 15 MG / 20MG / 1O MG | Download | |
| BOT2600197 | TADALAFIL | TALIS- 20 |
Cospharm Investments (Pty) Ltd No. 2 Concourse Crescent Lonehill, Johannesburg 2191 South Africa |
TABLETS | 20 MG | Download | |
| BOT260183 | Respiratory syncytial virus stabilized prefusion F subunit vaccine (bivalent, recombinant) | ABRYSVO |
Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs-Sint-Amands Belgium |
120 μg Powder and solvent for solution for injection | 120 μg | Download | |
| BOT2600190 | Carbetocin | Carbetocin |
FERRING INTERNATIONAL CENTER SA Chemin de la Vergognausaz 50 1162 St Prex Switzerland Phone: +41 58 301 00 00 |
100 µg /ml Solution for Injection | 100 µg /ml | Download | |
| BOT2600195 | Albendazole | Albendazole |
Cospharm Investments Pvt Ltd No. 2 Concourse Crescent, Lonehill, Johannesburg 2191 |
400mg tablets | 400mg | Download | |
| BOT2600205 | Moxifloxacin | Moxifloxacin |
MSN Laboratories Private Limited “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad – 500 018, Telangana, India |
400 mg Tablets | 400 mg | Download | |
| BOT2600177 | Dolutegravir (as sodium), Lamivudine and Tenofovir Disoproxil Fumarate Tablets 50/300/300 mg | Dolutegravir (as sodium), Lamivudine and Tenofovir Disoproxil Fumarate Tablets 50/300/300 mg |
Cipla Ltd., Cipla House, Peninsula Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai 400013 INDIA. |
Tablets 50/300/300 mg | 50/300/300 mg | Download | |
|
BOT2600213 BOT2600217 |
DOCETAXEL | DOCETAXEL 160MG/8ML - 80MG/4ML |
Cospharm Investments (Pty) Ltd, No. 2 Concourse Crescent Lonehill, Johannesburg 2191 South Africa |
160MG/8ML - 80MG/4ML solution for infusion | 160MG/8ML - 80MG/4ML | Download | |
| BOT2600216 | ELEMENTAL ZINC (AS ZINC GLUCONATE | ZINCORAL SYRUP |
COSPHARM PHARMACEUTICALS Stand 12896 Madokero Industrial Area Harare, Zimbabwe |
20MG/5ML ORAL SYRUP | 20MG/5ML | Download | |
|
BOT2600209 BOT2600164 BOT2600166 |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
SETAFORM ER 50/500 SETAFORM ER 50/1000 SETAFORM ER 100/1000 |
INNOVATA PHARMACEUTICALS (PTY) LTD Crownwood Office Park, 100 Northern Parkway Block D, Ground Floor, Ormonde, Johannesburg 2091, South Africa |
Extended-Release Tablets | - | Download | |
|
BOT2600210 BOT2600188 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE USP |
AVACARD-CO 80/25 AVACARD-CO 40/12.5 AVACARD-CO 80/12.5 |
INNOVATA PHARMACEUTICALS (PTY) LTD Crownwood Office Park, 100 Northern Parkway Block D, Ground Floor, Ormonde, Johannesburg 2091, South Africa |
80mg/25mg Tablets USP 40mg/12.5mg Tablets USP 80mg/12.5mg Tablets USP |
80mg/25mg 40mg/12.5mg 80mg/12.5mg |
Download | |
| BOT2600165 | RUPATADINE | NAISALLERG 10 |
INNOVATA PHARMACEUTICALS (PTY) LTD Crownwood Office Park, 100 Northern Parkway Block D, Ground Floor, Ormonde, Johannesburg 2091, South Africa |
10 mg tablets | 10 mg | Download | |
| BOT2600151 | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | ZIMDART TD |
ZIM LABORATORIES LIMITED B-21/22, M.I.D.C. Area, Kamleshwar – 441501 Dist. Nagpur, Maharashtra, India |
0.5 MG & 0.4 MG CAPSULES | 0.5 MG & 0.4 MG | Download | |
| BOT2600218 |
ETHYL SALICYLATE, 2-HYDROXYETHYL SALICYLATE, METHYL NICOTINATE AND METHYL SALICYLATE |
MENTHOLATUM DEEP HEAT SPRAY | MENTHOLATUM SOUTH AFRICA (PTY) LTD, 1st Floor, Silverberg Terrace, Steenberg Office Park, Silverwood Close, Tokai, Cape Town, 7945 | TOPICAL SPRAY | - | Download | |
| BOT2600169 | METHYL SALICYLATE AND MENTHOL CREAM 12,80 G METHYL SALICYLATE & 5,91 G MENTHOL PER 100 G. | MENTHOLATUM DEEP HEAT RUB | MENTHOLATUM SOUTH AFRICA (PTY) LTD, 1st Floor, Silverberg Terrace, Steenberg Office Park, Silverwood Close, Tokai, Cape Town, 7945 | TOPICAL SPRAY | - | Download | |
|
BOT2600196 BOT2600192 |
BUPROPION HYDROCHLORIDE |
BUDEP XR 300 BUDEP XR 150 |
RANBAXY PHARMACEUTICALS (Pty) Ltd 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724 Johannesburg, South Africa |
300mg - 150mg EXTENDED-RELEASE TABLETS | 300mg - 150mg | Download | |
|
BOT2600130 BOT2600134 |
DABIGATRAN | HETSOLID |
Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018. Telangana, India. |
110MG - 75MG CAPSULES | 110MG - 75MG | Download | |
| BOT2600148 | ETORICOXIB | ETROBAX |
Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018. Telangana, India. |
60MG TABLETS | 60MG | Download | |
| BOT2600132 |
DIOCTAHEDRAL SMECTITE BEIDELLITIC SMECTITE INTERGRADE (1.4 NM PHYLLITE), |
SMECTAGO |
Acino Pharma (Pty) Ltd 106 16th Road, Midrand South Africa |
3.0G POWDER FOR ORAL SUSPENSION | 3.0G | Download | |
| BOT2600179 | DOLUTEGRAVIR AND LAMIVUDINE | DIALDIN |
Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018. Telangana state, India. |
Tablets 50 mg/300 mg | 50 mg/300 mg | Download | |
| BOT2600106_110 | 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 | 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 |