HUMAN MEDICINAL PRODUCTS REGISTER

HUMAN MEDICINE REGISTERED PRODUCTS

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No. Registration No. Product Brand Name Generic Name Dosage Strength Dosage Form Pack Size Packaging Type Shelf Life Manufacturer's Name Manufacturer's Address Manufacturer Country Marketing Authorization Holder(MAH) Local Technical Representative(LTR) Registration Date Expiry Date
1 Rwanda FDA-HMP-MA-2081 Jadelle 2 x 75 mg implants Levonorgestrel 75mg Implants 1x10 sets of 2 subdermal implants Peelable Film bag PE nonwoven and PET/PE 60 Months BAYER OY turkuPansiontie 4720210 TurkuFinland Finland Bayer East Africa Limited SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

2 Rwanda FDA-HMP-MA-2052 Jadelle Sine Inserter Levonorgestrel 75 mg Implants 1 x 10 Implants 10 sets of two implants 60 Months BAYER OY Bayer Oy, Turku Pansiontie 47 20210 Turku Finland Finland Bayer East Africa Ltd SURGIPHARM (RWANDA) LTD 2024-09-30 2029-09-29

3 Rwanda FDA-HMP-MA-2009 JARDIANCE-10 EMPAGLIFLOZINE 10MG TABLETS 3×10 Tablets Alu–Alu PVC Blister 36 months Boehringer Ingelheim International GmbH KGBinger Straße 17355216 Ingelheim am Rhein GERMANY Germany BOEHRINGER INGELHEIM SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

4 Rwanda FDA-HMP-MA-1345 JITRIT-5 Tofacitinib citrate 8mg equivalent to Tofacitinib 5 mg 5 mg Film Coated Tablets 4 x 15 tablets Alu / PVC blister packed in a printed outer carton 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

5 Rwanda FDA-HMP-MA-1523 JUNIOR ZINC TABLETS Zinc Sulfate Monohydrate USP equivalent to Zinc 20mg 20MG TABLETS 10x10 Tablets Blister pack of 10x10’s in a unit carton with a literature insert 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. BOX 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-07-27 2029-07-26

6 Rwanda FDA-HMP-MA-2347 JUSTEEZ-50 VILDAGLIPTIN 50MG TABLETS 15 TABLETS ALU-ALU/ PRINTED BLISTER FOIL 24 Months EMCURE PHARMACETICALS LTD Lane No.3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu-181 133, India India EMCURE PHARMACEUTICALS LTD/INDIA ABACUS PHARMA (A) LTD 2025-06-19 2030-06-18

Registered