Summary of Products Characteristics (SMPC)

SMPC List - Rwanda FDA

Last updated: 29 September 2025

# Product Name
2001 Unitrim DS- Sulfamethoxazole 800mg and Trimethoprim 160mg Tablet - SmPC
2002 Univir 200mg tablets- Acyclovir 200 mg-SmPC
2003 Univir cream-Acyclovir 5% w per w-SmPC
2004 UNOSEMIDE 10 - Furosemide BP 10mg per ml Injection - SmPC
2005 Unosure-72 - Levonorgestrel 1.5mg tablets - SmPC
2006 UNOTATION - Tranexamic Acid Injection BP 500mg per 5ml- SmPC
2007 Unsiatem 80mg film-coated tablets - Febuxostat 80mg - SmPC
2008 Uperio-100 - Sacubitril Valsartan 100mg film coated tablets - SmPC
2009 Uperio-200 - Sacubitril Valsartan 200mg film coated tablets - SmPC
2010 Uperio-50 - Sacubitril Valsartan 50mg film coated tablets - SmPC
2011 Uprone.TM 40 Injection - Omeprazole Sodium 40mg - SmPC
2012 UPSA-C 1000 - Ascorbic Acid 1000mg Effervescents Tablets - SmPC
2013 UROKA 0.5MG -DUTASTERIDE-CAPSULES-SMPC
2014 Uroka plus - Dutasteride 0.5mg and Tamsulosin 0.4 mg hard capsules - SmPC
2015 Ursoliv 250 - Ursodeoxycholic acid 250mg Capsules - SmPC
2016 URYDOS 4 - Silodosin 4mg Capsules - SmPC
2017 URYDOS 8 - Silodosin 8mg Capsules - SmPC
2018 URYSOREN-10 - Solifenacin Succinate Tablets 10 mg - SmPC
2019 URYSOREN-5 - Solifenacin Succinate Tablets 5 mg - SmPC
2020 Utrogestan 200mg soft capsules - Progesterone 200mg micronized - SmPC
2021 Utrogestan vaginal 200mg soft capsules - Progesterone Ph Eur. (Micronized),200mg - SmPC
2022 UVEX 500-LEVOFLOXACIN-FILM COATED TABLETS-500 MG-SMPC
2023 V-IMMUNE - Human Normal Immunoglobulin for Intravenous Administration B.P 5 % - SmPC
2024 Valazyd-H 172.5 - Valsartan 160mg and hydrochlorthiazide 12.5mg tablets - SmPC
2025 Valcontin 200 - Controlled Release Tablets of Sodium Valproate 133.5 mg and Valproic acid 58 mg - SmPC
2026 Valcontin 500 - Controlled Release Tablets of Sodium Valproate 333 mg and Valproic acid 145mg - SmPC
2027 Valepsy-200 - Gastro-Resistant Sodium Valproate Tablets BP 200mg - SmPC
2028 Valepsy-300 - Gastro-Resistant Sodium Valproate Tablets BP 300mg - SmPC
2029 Valepsy-500 - Gastro-Resistant Sodium Valproate Tablets BP 500mg - SmPC
2030 VALPAGEN 200 - Sodium valproate Tablets BP 200 mg - SmPC
2031 Valpin 200 - Gastro Resistant Sodium Valproate Tablets BP 200 mg - SmPC
2032 VALSAR-HT 160-25 - Valsartan USP160mg and Hydrochlorothiazide USP 25mg - SmPC
2033 Valsar-HT 80-12.5 - Valsartan USP 80mg and Hydrochlorothiazide12.5mg - SmPC
2034 Vantox-CP - Vancomycin Hydrochloride 1gr - powder for injection - SmPC
2035 Vantox-CP - vancomycin hydrochloride 500mg - Powder for injection - SmPC
2036 VAROXA 10 - Rivaroxaban 10mg tablets - SmPC
2037 VAROXA 20 - Rivaroxaban 20mg tablets - SmPC
2038 Vast-20 - Atorvastatin 20mg tablets-SmPC
2039 Vastarel OD 40 mg - Trimetazidine Dihydrochloride 40 mg Tablets - SmPC
2040 Vastarel OD 80 mg - Trimetazidine Dihydrochloride 80 mg Tablets - SmPC
2041 VASTEN 25 - Cinnarizinne 25mg tablets - SmPC
2042 VASTEN-75 TABLETS-Cinnarizine 75 mg- SmPC
2043 Vaxato- Rivaroxaban 10mg Tablets- SmPC
2044 Vaxato- Rivaroxaban 15mg Tablets- SmPC
2045 Vaxato- Rivaroxaban 20mg Tablets- SmPC
2046 VAXIRAB N - Inactivated final bulk of rabies vaccine 2.5 IUVial Solution for injection - SmPC
2047 VEMLIDY_25__Tenofovir_alafenamide__film-coated_tablet-SMPC
2048 Venosmil 200mg capsules - Hidrosmin 200mg - SmPC
2049 Venosmil 20mg g gel - Hidrosmin 20mg - SmPC
2050 Ventolin 100 microgrammes per dose - Salbutamol Sulfate micronized 100 mcg - suspension for inhalation - SmPC