Summary of Products Characteristics (SMPC)

SMPC List - Rwanda FDA

Last updated: 29 September 2025

# Product Name
1101 Insulin Glargine Impact, Lantus ® 100 unitsml, Lantus ® 100 unitsml solution for injection - SmPC
1102 Intacycline skin Ointment- Tetracycline hydrochloride 3.0% W-W - SmPC
1103 Intamine Cream - Mepyramine Maleate BP 2.0% ww Cream - SmPC
1104 Intaplex Tablets - Nicotinamide BP 15mg, Riboflavin BP 1mg, and Thiamine Hydrochloride BP 1mg - SmPC
1105 INTRAZ - Itraconazole Capsules 100 mg - SmPC
1106 Intussed Coughs Suppressant- Dextrometorphan HBr 8mg, Ephedrine HCl 8mg and Promethazine HCl 4mg-SmPC
1107 Invega Sustenna 100 - Paliperidone Palmitate 100mg Solution for injection - SmPC
1108 Invega Sustenna 150 - Paliperidone Palmitate 150mg Solution for injection - SmPC
1109 Invega Sustenna 25 - Paliperidone Palmitate 25mg Solution for injection - SmPC
1110 Invega Sustenna 50 - Paliperidone Palmitate 50mg Solution for injection - SmPC
1111 Invega Sustenna 75 - Paliperidone Palmitate 75mg Solution for injection - SmPC
1112 Irbesartan & Amlodipine Besylate Impact 300 mg10 mg film-coated tablet- Irbesartanm300mg and Amlodipine Besylate 10mg- SmPC
1113 Irbesartan 300 mg and Hydrochlorothiazide Impact 12.5 mg film-coated tablets - SmPC
1114 Irbesartan Impact 150 mg Film-Coated Tablets- SmPC
1115 Irbesartan Impact 300 mg film-coated tablets - Irbesartan 300 mg - SmPC
1116 IRBIS 150- Irbesartan USP 150mg Tablets- SmPC
1117 IRBIS 300 - Irbesartan 300 mg Tablets - SmPC
1118 IRBIS HT 300-12.5 - Irbesartan 300 mg and Hydrochlorothiazide 12.5 mg Tablets - SmPC
1119 IRBIS-HT- Irbesartan and Hydrochlorothiazide 150mg12.5 mg Tablets- SmPC
1120 IRYS 1MG - Glimepiride 1mg tablets - SmPC
1121 IRYS 3MG - Glimepiride 3mg tablets - SmPC
1122 IRYS 4MG - Glimepiride 4mg tablets - SmPC
1123 Isoniazid and Rifapentine Coated Tablets (300mg+ 300mg)
1124 Isoniazid Tablets BP 100 mg- SmPC
1125 Isoniazid tablets BP 300mg - Isoniazid tablets BP 300mg - SmPC
1126 Itacare - Itraconazole 100mg Capsules - SmPC
1127 IVIPIME - Cefepime Hydrochloride USP 1gr Dry Powder for Injection-SmPC
1128 Ivytus Syrup 3.5 mg5 ml - Each 5 ml of the syrup contains dried Ivy leaf extract 0.035 g equivalent to 3.5 mg of Hederacoside C - SmPC
1129 IXAROLA 10 - Rivaroxaban 10 mg tablets - SmPC
1130 IXAROLA 15 - Rivaroxaban 15 mg tablets - SmPC
1131 IXAROLA 20 - Rivaroxaban 20 mg tablets - SmPC
1132 IXINE 200 - Cefixime Trihydrate USP 200MG tablets - SmPC
1133 Jadelle Sine Inserter- Levonorgestrel 75 mg Implants-SmPC
1134 Jadelle Sine Spamox 250-Amoxicillin trihydrate BP 250mg per 5ml oral suspension-SmPCInserter- Levonorgestrel 75 mg Implants-SmPC
1135 Jadelle Sine Spamox 250-Amoxicillin trihydrate BP 250mg per 5ml oral suspension-SmPCInserter- Levonorgestrel 75 mg Implants-SmPC
1136 JARDIANCE-10 - Empagliflozin 10mg Tablets - SmPC
1137 JENTIN-MET-SITAGLIPTIN + METFORMIN-TABLETS-50MG500MG-SMPC
1138 JENTIN-MET-SITAGLIPTIN-METFORMIN-TABLETS-50MG500MG-SMPC
1139 Jitrit 5 - Tofacitinib 5mg Tablets - SmPC
1140 Junior Zinc- Zinc Sulfate Monohydrate USP 20mg tablets- SmPC
1141 K-FLAM, Powder for oral solution - Diclofenac Potassium 50mg - SmPC
1142 Kabiven emulsion for infusion - SmPC
1143 Kamagra 100 - Sildenafil 100mg Tablets - SmPC
1144 Kamagra 50 tablets - Sildenafil Citrate USP equivalent to Sildenafil 50mg - SmPC
1145 Kamagra CT 100 - Sildenafil 100mg Tablets - SmPC
1146 Kamagra CT 50 - Sildenafil 50mg Tablets - SmPC
1147 Karecipro tablets - Ciprofloxacin hydrochloride 500mg - SmPC
1148 Kareclox 500mg - Cloxaciclin sodium 500mg - SmPC
1149 Karefenac Injection - Diclofenac Sodium 75mg - SmPC
1150 Karefotax Injection - Cefotaxime sodium 1g - SmpC