Summary of Products Characteristics (SMPC)

SMPC List - Rwanda FDA

Last updated: 16 February 2026

# Product Name
201 Anti-cough syrup - Ambroxol HCL 50mg-Guaiphenesin 15mg-Terbutaline Sulphate 1.5mg-Chlorpheniramine Maleate 2mg- Menthol 1mg - SmPC
202 Antihist Cream - Mepyramine maleate BP 2.0% ww - SmPC
203 ANZAVIR-ATAZANAVIR ,RITONAVIR - TABLETS-300MG100MG
204 APCALIS-SX 20-TADALAFIL 20 MG-TABLETS
205 APDROPS - Moxifloxacin Hydrochloride Eye Drops 0.5% wv - SmPC
206 Apexime 200mg-5ml -Azithromycine 200mg per 5ml Powder for oral suspension - SmPC
207 Apexime 500mg Tablets - Azithromycine - SmPC
208 APFLU - Paracetamol 500 mg, Pheniramine Maleate 25 mg, Ascorbic Acid 200 mg - Powder for suspension - SmPC
209 APFLU SYRUP-Chlorphenamine Maleate BP 0.5mg Paracetamol BP 120 mg and Vitamin C 50mg
210 APIBAN 5 - Apixaban 5mg Tablets - SmPC
211 Apretude prolonged release suspension for injection - Cabotegravir sodium- 600mg per3ml- SmPC
212 APRETUDE- Cabotegravir 30mg Film Coated Tablets-SmPC
213 Arbitel 40 - Telmisartan tablets 40 mg - SmPC
214 Arbitel AM - Telmisartan 40mg and Amlodipine 5mg tablets - SmPC
215 Arbitel-80 - Telmisartan 80mg Tablet - SmPC
216 Arbitel-80H - Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg Tablets - SmPC
217 Arbitel-H -Termisartan 40mg and Hydrochlorothiazide 12.5mg Tablets - SmPC
218 Arena - Adrenaline BP 0.1% Injection 1mg-ml - SmPC
219 Arimidex - Anastrozole 1mg tablets - SmPC
220 Arprel-10 - Prasugrel 10mg Tablets - SmPC
221 Arprel-5 - Prasugrel 5mg Tablets - SmPC
222 Artefan 20-120 - Artemether 20mg and Lumefantrine 120mg Tablets - SmPC
223 ARTEFAN 20-120-ARTEMETHER 20MG AND LUMEFANTRINE120MG-DISPERSIBLE TABLETS
224 ARTEFAN 40-240-ARTEMETHER 40MG AND LUMEFANTRINE 240MG- TABLETS
225 ARTEFAN 80-480-ARTEMETHER 80MG AND LUMEFANTRINE 480MG-TABLETS
226 Artemether 20mg & Lumefantrine 120mg tablets - Tablets - SmPC
227 Artesunate & Amodiaquine Tablets 50mg135mg- Artesunate 50mg & Amodiaquine 135mg- SmPC
228 Arthrix Capsules 100 mg -Celecoxib 100 mg Ph.Eur - SmPC
229 Arthrix Capsules 200 mg - Celecoxib 200 mg Ph.Eur. - SmPC
230 Ascipram 10mg film coated tablets - Escitalopram 10mg - SmPC
231 Ascipram 20mg film coated tablets - Escitalopram 20mg - SmPC
232 Ascoril Expectorant - Bromohexine Hydrochloride BP 4mg, Salbutamol sulphate 2mg, Guaifenesin USP 100mg - Syrup - SmPC
233 Asomex 2.5 - Amlodipine Besilate 2.5mg - SmPC
234 Asomex 5 - Amlodipine Besilate 5mg - SmPC
235 Asomex LT Tablets - Amlodipine besilate 2.5 mg and Losartan Potassium USP 50mg - SmPC
236 ASOMEX- D - Amlodipine 2.5mg and Hydrochlorothiazide 12.5mg Tablets - SmPC
237 Aspirin 300mg Tablets (Laboratory&Allied) - SmPC
238 Aspocan- Posaconazole 100mg Delayed Release Tablets- SmPC
239 ASTHAREN 4MG-Salbutamol Sulphate Bp 4.0 mg tablet - SmPC.pdf
240 Atacand 16mg-Candesartan cilexetil-Tablet-SmPC
241 Atacand 8mg-Candesartan cilexetil-Tablet-SmPC
242 Atacand plus 16-12.5 mg Tablet - Candesartan cilexetil 16mg and Hydrochlorothiazide 12.5mg - SmPC
243 Atazanavir (as sulfate) 300mg and Ritonavir 100mg Tablets-SmPC
244 ATAZOR-R Tablets - Atazanavir Sulfate 300 mg and Ritonavir 100 mg - SmPC
245 Atenolol Denk 50-Atenolol-Tablets-SmPC
246 ATOREM 10-Atorvastatin 10 mg-Tablets-Smpc
247 ATOREM 20-Atorvastatin 20 mg-Tablets-Smpc
248 Atosar H-Losartan Potassium 50mg and Hydrochlorothiazide 12.5mg Tablets USP- SmPC
249 Atracurium MédiS 25mg injection solution -Atracurium Besylate 25mg - SmPC
250 Atracurium MédiS 50mg injection solution - Atracurium Besylate 50mg - SmPC