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-1132 X SONE N Neomycin Sulphate 0.35% w/v, Dexamethasone Sodium Phosphate 0.1% w/v and and Benzalkonium chloride 0.01% w/v as preservative 0.35% w/v, 0.1%w/v & 0.01% w/v Eye/Ear drops 5ml filled in a 10ml bottle Low Density Polyethylene (LDPE) container with HDPE cap and Nozzle. 30 Months ABACUS PARENTERAL DRUGS LTD, Block 191, Plot No.114, Kinga Mukono, P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20
2 Rwanda FDA-HMP-MA-1457 XALME SPAS Mephenamic Acid BP 250mg and Dicyclomino Hydrochloride USP 10mg 250mg and 10mg Tablets 10 tablets A blister (Aluminium / PVC foil) of 10 tablets in inner carton along with the product insert 36 Months BLISS GVS PHARMA LTD. Plot No. 10, 11A, 12, Survey no. 38/1 Dewan Udyog Nagar, Aliyali Village, Taluka - Palghar, Thane - 401404 Maharashtra India, India INDIA BLISS GVS PHARMA LTD SUN ENTERPRISES LTD 2024-07-20 2029-07-19
3 Rwanda FDA-HMP-MA-0312 XARELTO 10MG Rivaroxaban 10mg 10mg Film coated tablets 1x10 tablets PP/ALU Blister Carton 36 Months BAYER AG, Leverkusen, Bayer AG, Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11
4 Rwanda FDA-HMP-MA-0313 XARELTO 15MG Rivaroxaban 15mg 15mg Film coated tablets 1x14 tablets PP/ALU Blister Carton 36 Months BAYER AG, Leverkusen, Bayer AG, Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11
5 Rwanda FDA-HMP-MA-0314 XARELTO 2.5MG Rivaroxaban 2.5 mg 2.5 mg Film coated tablets 2x14 tablets PP/ALU Blister Carton 36 Months BAYER AG, Leverkusen, Bayer AG, Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11
6 Rwanda FDA-HMP-MA-0747 XARELTO-20 TABLETS Rivaroxaban 20mg 20mg Film Coated tablets 1x14’s tablets PP/Alu Blister 36 Months BAYER AG, Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany GERMANY BAYER EAST AFRICA LIMITED WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-01-15 2029-01-14
7 Rwanda FDA-HMP-MA-1572 XAROBAN TABLETS Rivaroxaban 10mg Tablets 10 Tablets ALU-ALU BLISTER PACK 24 Months THE SEARLE COMPANY LIMITED F-319, S.I.T.E Karachi, Pakistan PAKISTAN THE SEARLE COMPANY LIMITED SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16
8 Rwanda FDA-HMP-MA-2337 XAROBAN-15 RIVAROXABAN 15MG FILM COATED TABLETS 1X10 Tablets ALU ALU BLISTER (1 X 10’S)/ UNIT CARTON 24 MONTHS SEARLE COMPANY LIMITED F319.S.I.T.E,KARACHI, PAKISTAN. TEL:0092-21-32578001, FAX:0092-21-32564667 PAKISTAN SEARLE COMPANY LIMITED SURGIPHARM RWANDA LTD 2025-07-11 2030-07-10

Registered
9 Rwanda FDA-HMP-MA-0386 XATRAL 2.5 mg Alfuzosin 2.5mg 2.5mg Film-Coated Tablets 30 tablets PVC /ALU Blister pack 24 Months SANOFI WINTHROP INDUSTRIE, 30-36 Avenue Gustave Eiffel 37100 Tour France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-09-06 2028-09-05
10 Rwanda FDA-HMP-MA-0421 XATRAL LP 10 mg Alfuzosin 10 mg 10 mg Film-Coated Tablets 30 tablets PVC /ALU Blister pack 36 Months SANOFI WINTHROP INDUSTRIE, 30-36 Avenue Gustave Eiffel 37100 Tours, France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-09-06 2028-09-05
11 Rwanda FDA-HMP-MA-0385 XATRAL LP 5 mg Alfuzosin 5mg 5mg Film-Coated Tablets 56’s tablets PVC /ALU Blister pack 36 Months SANOFI WINTHROP INDUSTRIE, 30-36 Avenue Gustave Eiffel 37100 Tour France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-07-08 2028-07-07
12 Rwanda FDA-HMP-MA-0705 XBETA Betamethasone sodium phosphate 0.1% w/v 0.1% w/v Solution 5ml &10ml Bottles LDPE Bottles 30 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29
13 Rwanda FDA-HMP-MA-0706 XBETA N Betamethasone sodium phosphate 0.1%w/v and Neomycin Sulphate 0.5% w/v 0.1%w/v and 0.5% w/v Solution 5ml &10ml Bottles LDPE Bottles 30 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29
14 Rwanda FDA-HMP-MA-2355 XEBISCO 75 PREGABALIN USP 75MG CAPSULES 3X10 CAPSULES THREE BLISTERS OF 10 CAPSULES TO BE PACKED IN ONE CARTON ALONG WITH LEAFLET 24 MONTHS BLISS GVS PHARMA LIMITED SURVEY NO. 43- 44, VEVOOR VILLAGE, PALGHAR 401404, INDIA INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2025-10-09 2030-10-08

Registered
15 Rwanda FDA-HMP-MA-1113 XELTIN Tofacitinib citrate equivalent to Tofacitinib 5 mg 5 mg Film Coated Tablets 3x10 Tablets Alu-PVC/PVdC blister, 3 such blisters are packed in a carton along with Patient Information Leaflet 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, Midc Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19
16 Rwanda FDA-HMP-MA-2104 XENDA 100 Bendamustine Hydrochloride Monohydrate 100 mg Injection 1×1 Vial VAILS (Fiolax Amber Tubular Glass Vials , Rubber stopper) 36 Months HETERO LABS LIMITED Hetero Labs Limited, Unit – VI Sy.No.410-411, TSIIC Formulation SEZ, Polepalle Village, Jadcherla Mandal, Mahabubnagar District, Pincode 509301, Telangana State, India. India HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
17 Rwanda FDA-HMP-MA-0731 XERIN Levocetirizine Hydrochloride 5mg and Montelukast Sodium USP 10 mg 5mg and 10 mg Film coated tablets 10 x 10 Tablets Alu-Alu Blister pack with printed carton along with pack insert 36 Months AKUMS DRUGS & PHARMACEUTICALS LTD, 19,20 & 21 Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA ABACUS PHARMA(A) LTD 2024-01-08 2029-01-07
18 Rwanda FDA-HMP-MA-2208 XILONE Syrup Prednisolone Sodium Phosphate (6.7 mg) (equivalent to Prednisolone) (5mg) 5 mg/5ml SYRUP 100 ml Bottle Amber (type III) glass bottle, with white polypropylene cap with (LDPE) cap foam liner 36 Months EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES Cairo Desert Road KM 25, PO Box 111, El Manshia Alex. Town: Amriya, Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03
19 Rwanda FDA-HMP-MA-1278 XPEL SYRUP 15 MG/5 ML Ambroxol Hydrochloride 15mg/5 ml 15mg/5 ml Syrup 100 ml Bottle 125 ml amber glass bottle sealed with child-resistant cap (CRC) and packed in a printed carton 36 Months NEOPHARMA, Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAE UAE NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06
20 Rwanda FDA-HMP-MA-1279 XPEL SYRUP 30MG/5 ML Ambroxol Hydrochloride 30mg/5 ml 30mg/5 ml Syrup 100 ml Bottle 125 ml amber glass bottle sealed with child-resistant cap and packed in a printed carton 36 Months NEOPHARMA, Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAE UAE NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06
21 Rwanda FDA-HMP-MA-0526 XSONE Dexamethasone Sodium Phosphate 0.1% w/v 0.1% w/v Ophthalmic solution 10ml and 5ml plastic ampoules Sealed transparent plastic ampoules 36 Months ABACUS PARENTERAL DRUGS LTD. (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04
22 Rwanda FDA-HMP-MA-2017 XYLOCAINE GEL 2% XYLOMETAZOLINE HYDROCHLORIDE 20MG GEL 30 g Tube Collapsible tubes and contained in a unit box with literature insert 24 Months RECIPHARM KARLSKOGA AB Björkbornsvägen 5, SE-691 33 Karlskoga Sweden BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16
23 Rwanda FDA-HMP-MA-2087 XYLOCAINE GEL 2% XYLOMETAZOLINE HYDROCHLORIDE 20MG GEL 30 g Tube Collapsible tube made of aluminium internally coated with protective lacquer 24 Months RECIPHARM KARLSKOGA AB Björkbornsvägen 5, SE-691 33 Karlskoga Sweden BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16
24 Rwanda FDA-HMP-MA-0732 XYLOCAINE SPRAY 10% Lidocaine 10mg 10mg Solution spray 1 bottle of 50ml Vials made of type I molded glass 50ml, packed with short bent spray nozzle 36 Months AstraZeneca AB, Forskargatan 18, SE-151 85 Södertälje, Sweden SWEDEN BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14