Summary of Products Characteristics (SMPC)

SMPC List - Rwanda FDA

Last updated: 16 February 2026

# Product Name
301 AZITRINE-500 - Azithromycin dihydrate USP 500mg Tablets - SmPC
302 Aziwin 500 - Azithromycin USP 500mg tablets - SmPC
303 Azopt eye drops Suspension - brinzolamide 10mg-ml - SmPC
304 Azunate - Artesunate Ph. Int. 60mg - Powder for injection - SmPC
305 Bactoclav 625 - Amoxicillin 500 mg and Potassium clavulanate 125 mg tablets - SmPC
306 Bactoclav Dry Syrup - Amoxicllin100 mg per ml and Potassium Clavulanate 12.5 mg per ml - SmPC
307 BACTOX 125mg-5ml - Amoxicillin powder for oral suspension - SmPC
308 BACTOX 250 mg -5 ml - Amoxicillin powder for oral suspension - SmPC
309 BACTOX 500mg - Amoxicillin tablets- SmPC
310 BACTOX 500mg-5ml - Amoxicillin powder for oral suspension - SmPC
311 Balfen - Ibuprofen BP 200mg tablets - SmPC
312 Balfen - Ibuprofen tablets BP 400mg - SmPC
313 Baltrim 480mg tablets - Sulfamethoxazole 400mg and Trimethoprim 80mg - SmPC
314 Baltrim Forte tablets - Trimethoprim 160mg and Sulfamethoxazole 800mg - SmPC
315 Barole - Rabeprazole Sodium for injection 20mg - SmPC
316 Barole 20 - Rabeprazole Sodium 20mg - Enteric coated capsules - SmPC
317 BCG-VACCINE-FREEZE-DRIED-BACILLUS-CALMETTE-GUERIN-2-x-105-and-8-x-105-C.F.U-LYOPHILISED-INJECTION
318 Beclomin 250 HFA Inhaler - Beclometasone Dipropionate 250 ?g per Puff - SmPC
319 Becoactin syrup 200ml - Cypohertadine Hydrochloride USP 2mg - SmPC
320 Becoactin Tablets - Cyproheptadine Hydrochloride USP 4 Mg& B Vitamins(B1 4mg ,B2 2mg ,B6 0.5mg ,B12 1mg ) &Minerals 1mcg - SmPC
321 Becoren tablets- Vitamin B1,Mononitrate 0.5mg, Vitamin B2 0.5mg, Vitamin B6 0.5mg and Niacinamide7.5mg-SmPC
322 Bedaquiline Tablets 100mg - Bedaquiline Fumarate 100mg - SmPC
323 Bekracine-200 Dispersible Tablet - Cefixime 200mg - SmPC
324 BEKRACINE__CEFIXIME__100MG_POWDER_FOR_ORAL_SUSP-SMPC
325 Bekrazol 200 - Albendazole BP 200mg per 5ml oral suspension-SmPC
326 Bekrazol 400- Albendazole BP 400mg tablets-SmPC
327 Benduric 5mg Tablets - Bendroflumethiazide 5mg - SmPC
328 Benylin Dry Cough - Dextromethorphan Hydrobromide 15mg -5ml - SmPC
329 Benylin with Codeine - Diphenhydramine Hydrochloride, Ammonium Chloride, Codeine Phosphate Syrup - SmPC
330 BENZALIN- Benzathine benzlpenicillin for injection 2.4 MUI-SmPC
331 Benzathine benzylpenicillin for injection 2.4 mega - SmPC
332 Benzosed Injection- Midazolam BP 1mg per 5ml- SmPC
333 Besicor 10-Bisoprolol Tablets BP 10mg SmPC
334 Besicor 5 - Bisoprolol tablets BP 5mg - SmPC
335 Betadine Antiseptic Cream 5% - Povidone Iodine 5% - SmPC
336 Betadine Germicide Gargle 2%-Mint - Povidone Iodine 2% - SmPC
337 Betadine Ointment 5% WW - Povidone-Iodine USP 5% WW - Ointment - SmPC
338 Betadine Standardised Microbicidal Solution 10% - Povidone-Iodine USP 10% wv - SmPC
339 Betadine Standardised Microbicidal Solution 5% - Povidone-Iodine USP 5% wv - SmPC
340 Betadine surgical scrub 7.5% - Povidone Iodine USP 7.5% wv - SmPC
341 Betasilic ointment - Betamethasone 0.5mg and Salicylic acid 30 mg - SmPC
342 Betoptic 0.5% wv Eye Drops Suspension - Betaxolol (as hydrochloride) - SmPC
343 Betrim 480 - Co-trimoxazole tablets BP 480mg - SmPC
344 Betrim forte - Co-trimoxazole tablets BP 960mg - SmPC
345 Bevaas 400-Bevacizumab injection 400mg in 16 ml single dose vial-SmPC
346 Bevaas-100-Bevacizumab-injection-100mg-in-4-ml-single-dose-vial-SmPC
347 BGMET - Metformin Hydrochloride BP 500mg Tablets - SmPC
348 Bi Preterax 5mg/1.25mg film-coated tablets- perindopril arginine 5 mg and indapamide 1.25 mg- SmPC
349 Bi-Preterax 10mg-2.5mg film-coated tablets - Perindopril arginine 10mg and Indapamide 2.5 mg - SmPC
350 Bicalutamide 150 mg film-coated tablet - SmPC