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SmPC/PI/PIL Repository

SmPC/PI/PIL Repository

OUR

SmPC/PI/PIL Repository

Active Pharmaceutical Product API(s) Brand Name Market Authorization holder Dosage Form(s) Strength(s) PI PIL
Glycopyrrolate ROBINUL Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive Injectable Solution 0.2mg/ml 0.4mg/2ml Download No
Paracetamol, Diphenhydramine Hydrochloride, Codeine Phosphate ,Caffeine Anhydrous LENADOL Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive Tablet 450mg Paracetamol, 5mg Diphenhydramine Hydrochloride,10mg Codeine Phosphate, 50mg Caffeine Anhydrous Download Download
Tretinoin ILOTYCIN A GEL Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive Gel 0.05g/100g Tretinoin Download No
Spironolactone SPIRACTIN Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive Tablet 25mg Spironolactone Download No
Amlodipine NORVASC Viatris Healthcare (Pty) Ltd 4 Brewery Street Isando, Gauteng, 1609, Postnet Suite 23, Private Bag X10010, EDENVALE , 1610 Tablets 5mg and 10mg Amlodipine Downloads Download
Amlodipine LOMANOR Viatris Healthcare (Pty) Ltd 4 Brewery Street Isando, Gauteng, 1609, Postnet Suite 23, Private Bag X10010, EDENVALE , 1610 Tablets 5mg and 10mg Amlodipine Download Download
Codeine Phosphate,       Ibuprofen, Paracetamol CIPYNE Varichem Pharmaceuticals (Pvt) Ltd 194 Gleneagles Road, Willowvale Capsules Varichem Pharmaceuticals (Pvt) Ltd 194 Gleneagles Road, Willowvale No Download
Diphenhydramine Hydrochloride, Pseudoephedrine Hydrochloride, Paracetamol CORILIEF Varichem Pharmaceuticals (Pvt) Ltd 194 Gleneagles Road, Willowvale Tablet 12,5mg Diphenhydramine hydrochloride , 22.5mg Pseudoephedrine hydrochloride, Paracetamol 500 No Download
Insulin Lispro HUMALOG Eli Lilly First Floor, Golden Oak House, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston, 2191 Private Bag X119, Bryanston, 2021 Injection 100IU/ML Insulin Lispro Download Download
Azathioprine AZATHIOPRINE TEVA PHARMACEUTICALS (PTY) LTD 2000/025840/07 G.A Van Niekerk (South Africa), B.C Budler (South Africa) T. Segal (Israeli) 181 Floor, Buildlng3, Maxwell Office Park, Magwa Crescent West, Waterfall City, Midrand, Gauteng, South Africa Tablets 50mg Azathioprine Download Download
Methylphenidate Hydrochloride CONCERTA JANSSEN PHARMACEUTICA (PTY) LTD. 2 Medical Road Halfway House Extended Release Tablets 18mg, 27mg, 36mg and 54 mg Methylphenidate Hydrochloride Download Download
Sildernafil VIAGRA Viatris Healthcare (Pty) Ltd 4 Brewery Street Isando, Gauteng, 1609 Postnet Suite 23, Private Bag X10010, Edenvale, 1610 Tablets 25mg, 50mg and 100mg Sildernafil Download Download
Sildernafil AVIGRA Viatris Healthcare (Pty) Ltd 4 Brewery Street Isando, Gauteng, 1609 Tablets 25mg, 50mg and 100mg Sildenafil Download Download
Venlafaxine Hydrochloride EFEXOR XR Viatris Healthcare (Pty) Ltd 4 Brewery Street Isando, Gauteng, 1609 Capsules 75mg and 150mg Venlafaxine Hydrochloride Download Download
Flurbiprofen STREPSIL INTENSIVE Reckitt Benckiser Pharmaceuticals (Pty) Ltd Lozenges 8.75mg Flurbiprofen Download Download
Atomoxetine Hydrochloride CYMBALTA Eli Lilly First Floor, Golden Oak House, Ballyoaks Office Park, 35 Ballyclare Drive,Private Bag X119, Bryanston, 2021 Capsules 30mg and 60mg Atomoxetine Hydrochloride Download Download
Filgrastim ZARZIO Sandoz SA Magwa Crescent West, Waterfall City, Juskei View, 2090, South Africa Solution for Injection 30MU/0.5ml and 48MU/0.5ml Filgrastim Download Download
Levodopa, Benserazide Hydrochloride MADOPAR Roche Products Building E, Hertford Office Park, 90 Bekker Road, Vorna Valley, Midrand 1686 Tablets 200mg Levodopa, 50mg Benserazide Hydrochloride Download Download
Alpelisib PIVITKO Novartis The Novartis Building, Magwa Crescent West, Waterfall City, Jukskei View Tablets 50mg,150mg and 200mg Alpelisib Download Download
Lithium Carbonate CAMCOLIT Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive Tablets 250mg and 400mg Lithium Carbonate Download Download
Salbutamol Sulfate VENTEZE Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive Respirator Solution 5mg/1ml Salbutamol Sulfate Download No
Tramadol Hydrochloride TRAMADOL DENK Denk Pharma GmbH&Co Prinzregentenstr 79, 81675 Solution for Injection 100mg/2ml Tramadol Hydrochloride Download Download
Anastrozole ANASTROZOLE DENK Denk Pharma GmbH&Co Prinzregentenstr 79, 81675 Tablets 1mg Anastrozole Download Download
Diclofenac DICLO DENK INJECTION Denk Pharma GmbH&Co Prinzregentenstr 79, 81675 Solution for Injection 75mg/3ml Diclofenac Download Download
Acyclovir ACYCLOVIR DENK Denk Pharma GmbH&Co Prinzregentenstr 79, 81675 Tablet 200mg Acyclovir Download Download
Levothyroxine Sodium ELTROXIN Pharmacare Limited Building 12, Healthcare Park, Woodlands Drive Tablet 25 µg, 50 µg, 75 µg, 100 µg and 200 µg Download No
Imatinib Mesylate GLEEVEC Novartis The Novartis Building, Magwa Crescent West, Waterfall City, Jukskei View Tablet 400mg Imatinib Mesilate Download Download
Pregabalin Antixienty 75 Mylan Laboratories LTD, India Hard Capsules 75 mg Yes No
Artesunate Artecap Strides Shasun Limited Rectal Capsules 100mg Yes No
Ceftriaxone & Sulbactam Ceftisone-S 1.5g Unosource Pharma LTD, India Solution for injection 1.5g Yes No
Montelukast Glemont-IR 10 Glenmark Pharmaceuticals Limited Tablets 10mg Yes Yes
Azithromycin Jubilant Azithromycin Jubilant Portfolio Pharmaceuticals Botswana Pty Ltd Tablets 500mg Yes No
Cefuroxime Cortum Unosource Pharma LTD, India Tablets 250/500mg Yes No
Tacrolimus Tacroz Forte Ointment Glenmark Pharmaceuticals Limited Ointment 0.1% w/w Yes No
Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumarate Vonavir Emcure pharmaceuticals Ltd, India. Tablets 600/200/300 mg Yes No
Cefepime Teico-500 M. J. Biopharm Pvt. Ltd. Solution for injection 500mg Yes No
Diclofenac Relaxo Lincoln Parenteral Limited Solution for injection 25mg Yes No
Oxytocin CP-Oxytocin Injection Steril-Gene Life Sciences (P) Ltd Solution for injection 10 IU/mL Yes No
Tenofovir Disoproxil Fumarate, Lamivudine and Dolutegravir Tenofovir Disoproxil Fumarate, Lamivudine and Dolutegravir Strides Pharma Science Limited Tablets 300 mg /300 mg/ 50 mg Yes No
Salmeterol Avasalf 50 ELPEN Pharmaceutical Co Inc Elpenhaler 50µ Yes No
Trastuzumab Ogivri™ Mylan Laboratories LTD, India Solution for injection 150 & 440 mg Yes No
Tadalafil Tadala-Denk Denk Pharma GmbH & Co. KG Tablets 20mg Yes No
Mepyramine Allergex Mepyramine Cream Adcock Ingram Limited Cream 2% w/w Yes No
Sofosbuvir and Velpatasvir MyHep ALL Mylan Laboratories LTD, India Tablets 400 mg/100 mg Yes Yes
Levonorgestrel Sino-Implant (II) Shanghai Dahua Pharmaceutical Co. Ltd Implant 75 mg Yes No
Dolutegravir/ Lamivudine/ Tenofovir disoproxil fumarate Dolutegravir/ Lamivudine/ Tenofovir disoproxil fumarate Sun Pharmaceutical Industries Limited Tablets 50mg/300mg/300mg Yes No
Dexamethasone sodium phosphate Dexamethasone phosphate USP SWISS PARENTERALS LTD. 808, 809, 810 Kerala Industrial Estate, G.I.D.C, Nr, Bavla, Dist. Ahmedabad-382 220. Gujarat, India Solution for injection 8mg/2ml Yes Yes
Etoposide Etoposide Injection USP NAPROD LIFE SCIENCES PVT. LTD. 304, Town Centre, Andheri kurla road, near Mittal Estate Andheri (East.) Mumbai 400 059 Maharastra INDIA Solution for injection 100mg/5ml Yes Yes
Dapagliflozin Dapzin Micro labs limited. 31, Race Course Bangalore 560001 India Tablet 5mg and 10mg Yes Yes
Emtricitabine/Rilpivirine/tenofovir disoproxil fumarate Erestz Mylan laboratories Plot No 564/A/22, road number 92, Jubilee hills. Tablet 200mg/25mg/300mg Yes Yes
Paracetamol BP Regamol BAL PHARMA LIMITED 21 & 22, Bommasandra Industrial Area, Bangalore - 560 099, INDIA. Tablet 500mg Yes Yes
Nepafenac Ilevro Norvatis Pharma service AG Lichtstrasse 35 4056 Basal Switzerland Eye drop suspension 3mg/ml Yes Yes
Meropenem Merianz Not included. Powder for solution for injection/infusion 500mg and 1000mg Yes Yes
Methylprednisolone sodium succinate USP Succimed PLOT NO-50 AB, Govt Industrial Estate, Charkop, Kandivali (W) Mumbai 400 067 INDIA Tel. No.: +91 22 24163 9000 Fax No.: +91 22 24163 9100 Dry powder for injection 500mg Yes Yes
Cisplatin Cisplatin BP Not included. Solution for injection 0.5mg/1mg No Yes
Sitagliptin + Metformin Sime Cospharm Investments (Pty) Ltd 1E Morning field Complex, Morning ford Road, Parklands, Cape Town, South Africa. Tablet 50mg/850mg and 50mg/1000mg Yes No
Enalapril Viace Varichem Pharmaceuticals (Pvt) Ltd Harare, Zimbabwe Tablet 5mg No Yes
Vildagliptin + Metformin VIM Cospharm Investments (Pty) Ltd 1E Morning field Complex, Morning ford Road, Parklands, Cape Town, South Africa. Tablet 50mg/850mg and 50mg/1000mg No Yes
Tranexamic acid Tranex 500 Cospharm Investments (Pty) Ltd 1E Morning field Complex, Morning ford Road, Parklands, Cape Town, South Africa. Tablet 500mg Yes No
Tranexamic acid Tranexamic EMCURE Pharmaceutical Limited Tablet 500mg Yes No
Clotrimazole Clotrimazole BP Not Included Tablet 100mg Yes No
Tranexamic acid and mefenamic acid Pause MF Not Included Tablet 500/250mg Yes No
Indomethacin Athrexin PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191 South Africa Suppository 100mg No Yes
Hyoscine n-butylbromide Hyospasmol PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191 South Africa Injection 20mg/ml No Yes
Sacubitril Valsartan Sodium Hydrate Uperio Novartis Pharma Services AG Lichtstrasse 35, Novartis Campus CH-4056, Basel Switzerland Film Coated Tablets 10mg 100mg 200mg Yes Yes
Background

The Medicines Regulatory Authority (“Authority”) is a corporate body established under Section 3 of the Medicines and Related Substances Act (“MRSA”) and referred to as the Botswana Medicines Regulatory Authority or BoMRA. The Authority is responsible for ensuring the safety, efficacy, and quality of medicines and related substances, including human and veterinary medicines, medical devices, and cosmetics in Botswana.

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Dr. Seima Dijeng

Dr Seima Dijeng is the Chief Executive Officer (CEO) of BoMRA. Before assuming the acting appointment role, he served as the Director of Licensing and Enforcement, overseeing inspections and licensing of premises, laboratory services, import and export control, and enforcement.

A career regulatory professional with over 15 years of experience across both the food and pharmaceutical sectors. He has been part of the BoMRA executive management since 2018.

During his tenure as the Director, he coordinated the development of structures, processes, and guidelines to support regulatory activities and services for the licensing and enforcement department.

He holds a Master of Science in Food, Safety, and Risk Analysis from University College Dublin, the Republic of Ireland, Bachelor of Veterinary Science, from the University of Queensland in Australia.

Dr. Kefentse Motshegwa

Dr. Motshegwa is the Director of Veterinary Services at the Ministry of Agriculture. His illustrious career in veterinary services spans over 23 years in various positions within the veterinary space.

He previously served as Deputy Director – Compliance at the Department of Veterinary Services, Chairperson of the National Residue Committee, and Coordinator of Performance of Veterinary Services Evaluation for the World Organisation for Animal Health founded as OIE.

He brings to the Board a wealth of experience in compliance and regulation in animal health, food safety & veterinary medicines. He is a member of the Botswana Vaccine Institute Board of Directors.

He holds a Master of Science in Biology and Control Parasitic Diseases and Vectors from the University of Liverpool, School of Tropical Medicine, and a Bachelor of Veterinary Medicine from the University College Dublin, Ireland

Dr. Ditiro Duma Coyne

Dr. Coyne is a veterinarian with a career spanning over 15 years in mixed private practice in Gaborone. He has been actively involved in animal welfare and has been the veterinary advisor to the Botswana Society for the Prevention of Cruelty to Animals for several years.

He was the President of the Botswana Veterinary Association for 8 years and has made great strides in advancing Continuous Professional Development for Veterinarians in the country. He brings to the Board vast experience in veterinary education and advocacy as well as Animal Health and Production.

He is currently the World Small Animal Veterinary Association Country Representative for Botswana.

He holds a Bachelor of Veterinary Medicine and Surgery, and a Bachelor of Sciences Veterinary Biology both from Murdoch University, Australia.

Ms. Elizabeth Kelentse

Ms. Kelentse is the Pharmaceutical Care Improvement Specialist at the Botswana-University of Maryland School of Medicine Health Initiative.

She is an enthusiastic and hardworking Pharmacist who brings vast experience to the Board. Her career spans over 12 years from clinical pharmacy to community pharmacy, medicines regulatory experience in the evaluation of clinical trials protocols, and pharmacovigilance: health care management and public health programming.

She has served on the executive committees of the Pharmaceutical Society of Botswana, Botswana Health Professions Council, Young African Leaders Initiative Alumni as well as the National Adverse Events Following Immunisation.

She holds a Bachelor of Science (Pharmacy) University of West Indies St Augustine, Trinidad & Tobago.

Ms. Matshediso Matome

Ms. Matshediso Matome is a Faculty of Health Sciences lecturer at the University of Botswana. She is a seasoned academic who brings to the Board vast experience in the areas of research, health risk management, and delivery of innovative, quality, and cost- effective healthcare solutions for the public and private sectors.

Ms. Matome has previously served in various leadership and senior management positions, including Claims Manager and Head of Managed Care at the Associated Fund Administrators.

She holds a Master’s degree in Pharmacology and Toxicology from, the State University of New York Buffalo, NY, USA, and a Bachelor of Pharmacy, from Albany College of Pharmacy, Albany, USA

Dr Kobedi Segale

Dr. Segale is the Registrar of the Veterinary Surgeons Council. He is a passionate veterinary surgeon with intimate experience in the regulation of the veterinary profession. He has previously served as Deputy Director – Disease Control Division, in the Department of Veterinary Services, responsible for national animal health strategies, programs, and legislation. Dr. Segale brings to the Board a wealth of experience in monitoring and evaluating animal health programs veterinary public health, import and export controls, and animal traceability.

He holds a Master of Science in Tropical Animal Health, from the Institute of Tropical Medicine, Antwerpen, Belgium, and a Bachelor’s degree in Veterinary Medicine from the University College of Dublin, Ireland.

Ms. Mmama Mhlanga – Fichani

Ms. Mhlanga – Fichani is the Vice President, Human Resources and Communications, at Khoemacau Copper Mining. She is a human resources professional with an illustrious career, spanning over15 years in senior management positions. She has held senior leadership positions in diverse industries including, Director of Human Resources at Air Botswana and the Country Head of Human Resources at Standard Chartered Bank Botswana, Head of Human Resources at Be Mobile, Human Resources Manager at African Comprehensive HIV/AIDS Partnership and Human Resource Manager at Non-Bank Financial Institutions Regulatory Authority, respectively.

She brings to the Board vast experience in human resources and communication, organisational effectiveness, employee relations, and change management.

Ms. Mhlanga – Fichani holds a Master’s Degree in Business and Workforce Development from the University of Pennsylvania, USA, a Bachelor of Science in Business Management Human Resources Management, and Marketing Management, from Fairmont College, West Virginia USA, and a Degree of Associate of Science in Business Science- Human Resources Management, September, Calhoun State Community College, Decatur, Alabama, USA.

Mr. Modisa Kebonyemodisa

Mr. Kebonyemodisa is a Partner at Kebonyemodisa Law Office, he is admitted attorney of the High Court of Botswana. Before venturing into private practice, he worked as a Senior Prosecution Counsel at the Directorate of Public Prosecutions.

Mr. Kebonyemodisa is an accomplished legal advisor with over 15 years of experience providing legal counsel to businesses of all sizes. He brings to the Board vast experience in legal practice, corporate law, and extensive knowledge in the legal profession.

He holds a Bachelor of Law degree from, the University of Botswana and Trial Advocacy, Justice Advocacy Training (NITA) (Botswana)

Ms. Tiny Ralefala

Ms. Ralefala is a finance professional with a proven record of leadership, corporate governance, and risk management.

Her impressive professional track record spans over 26 years in finance, audit and accounting in reputable institutions as well as in civil service.

She previously worked as the Chief Finance Officer for Citizen Entrepreneurial Development Agency. Prior to her joining Citizen Entrepreneurial Development Agency she worked as the Finance Manager at the Motor Vehicle Accident Fund.

As a Chartered Financial Accountant, Ms. Ralefala brings to the Board a wealth of experience accustomed to managing projects in finance, audit and risk. She holds a Bachelor of Commerce degree from the University of Botswana. Ms. Ralefala is a fellow member of the Association of Chartered Accountants and the Botswana Institute of Chartered Accountants. She is the current Botswana Institute of Chartered Accountants Practice Review Committee Chairperson.

Dr. Lorato Mangadi-Mokama

 Dr. Lorato Mangadi- Mokama is the  Head of Operations at the Botswana Public Officers Medical Aid Scheme.
She has previously held other  leadership roles within the private healthcare industry, including Chief Operations Officer at the Botswana Medical Aid Society and Managing Director at MRI Botswana Limited. Prior to that, she practiced as a medical doctor in the public health sectors of Australia and Botswana.

Healthcare administrator and funding expert, with her extensive background in the private healthcare industry, she brings to BoMRA a wealth of experience and knowledge in business management and leadership.

She holds a Bachelor of Medicine from the University of Newcastle (Australia) and a Master of Business Administration from the University of Botswana.

She also has various leadership and professional certifications including Executive Leadership Program from Wits Business School and Healthcare Economics from Harvard Business School

Dr. Kegomoditswe Biki Maphane

Dr Kegomoditswe Biki Maphane is the Senior Manager – Safety and Sustainability Development at Debswana Diamond Company, Jwaneng Mine. He is a specialist in Occupational Medicine, Safety & Sustainable Development.

He has held various positions within the Debswana mines, including the Jwaneng Mine Hospital superintendent, and rose to executive leadership.

Dr Maphane provides leadership to the BoMRA Board and oversees the governance and strategic direction of the Authority. He holds a Bachelor of Medical Sciences, and Bachelor of Medicine / Bachelor of Surgery from the University of Melbourne, Australia