Public View of Electronically Registered Products

Certificates issued on 17-Apr-2020

Electronically Registered Product Details

#Local Technical RepresentativeApplication NumberProduct Trade NameHuman VetLocal ForeignInn Of ApiApi Strength Per DosageProduct Registration NoDosage Form NameRoutes NameEvaluatedShelf Life NameProduct Visual DescAtc Code NamePharmacotherapeutic GroupMah Company NameMah Company AddressMah Company EmailSite NameSite AddressStatus NameStatus Description
1PHILLIPS THERAPEUTICS LIMITED12281Brintellix 20 mgHumanForeignVortioxetine (as hydrobromide)20 mg per tabletH2020/CTD6341/12281Film-Coated TabletORALRecommended48 monthsRed, almond-shaped film-coated tablet engraved…N06AXOther AntidepressantsH. Lundbeck A/SOttiliavej 9, DK-2500, Valby-Copenhagen, Denmarkinformation@ lundbeck.comH.LUNDBECK A/SOTTILIAVEJ 9,DK-2500 VALBY-COPENHAGEN, DENMARKRegisteredValid
2LABOREX KENYA LTD-MOMBASA ROAD12311Bevacizumab AMRINGHumanForeignBevacizumab25 mg/mlH2020/CTD6453/12311Solution For InfusionINTRAVENOUSRecommended24 monthsClear or slightly opalescent, colorless or…L01XCOther antineoplastic agents: Monoclonal antibodiesAMRING FARMA S.R.L.BLVD. MIRCEA ELIADE 7, SECTOR 1, BUCURESTI,…officeromania@amringpharma.comPHARMADN S.A.PHARMADN S.A.RegisteredValid
3REGAL PHARMACEUTICALS LTD12607UNITRIM DS TABLETSHumanLocalSulfamethoxazole B.P & Trimethoprim B.PEach tablet contains; Sulfamethoxazole B.P 800mg…H2020/CTD6398/12607TabletORALRecommended24 monthsWhite, Capsule shaped, biconvex tablet, scored on…J01EE01sulfamethoxazole and trimethoprimRegal Pharmaceuticals LimitedPlot No.: 7879/18, Off Baba Dogo Road, Ruaraka,info@regalpharmaceuticals.comREGAL PHARMACEUTICALS LTDBABA DOGO RD, RUARAKARegisteredValid
4GENERICS AFRICA LTD12817MONTEER® (10/10) mg F.C TabletsHumanForeignAmlodipine Besylate Ph.Eur. equivalent to…Each tablet contains: Amlodipine besylate Ph.Eur.…H2020/CTD6529/12817Film-Coated TabletORALRecommended24 monthsOval blue non-scored film coated tablets,…C10BX03atorvastatin and amlodipineUnited Pharmaceuticals Mfg. Co. LtdNuzhatSahab, Al-Raqeem- Near public security…najwa.kaware@mspharma.comUNITED PHARMACEUTICAL MFG. CO. LTDP.O. BOX 69 AMMAN 11591 JORDANRegisteredValid
5GENERICS AFRICA LTD12820MONTEER ® (5/10) mg F/C TabletsHumanForeignAmlodipine Besylate Ph.Eur. equivalent to…Each tablet contains: Amlodipine Besylate Ph.Eur.…H2020/CTD6531/12820Film-Coated TabletORALRecommended24 monthsOval white non-scored film coated tablets,…C10BX03atorvastatin and amlodipineUnited Pharmaceuticals Mfg. Co. LtdNuzhatSahab, Al-Raqeem- Near public security…najwa.kaware@mspharma.comUNITED PHARMACEUTICAL MFG. CO. LTDP.O. BOX 69 AMMAN 11591 JORDANRegisteredValid
6LABOREX KENYA LTD-MOMBASA ROAD12905RITUXIMAB AMRINGHumanForeignRITUXIMAB10MG/MLH2020/CTD6828/12905Concentrate For Solution For InfusionINTRAVENOUS DRIPRecommended24 monthsA clear or slightly opalescent, colorless or…L01XC02rituximabAMRING FARMA S.R.L.BLVD. MIRCEA ELIADE 7, SECTOR 1, BUCURESTI,…officeromania@amringpharma.comPHARMADN S.A.PHARMADN S.A.RegisteredValid
7PHILLIPS THERAPEUTICS LIMITED13009Ryzodeg® FlexTouch®HumanForeignInsulin Degludec and Insulin Aspart70% insulin degludec / 30% insulin aspart,…H2020/CTD6669/13009Solution For InjectionSUBCUTANEOUSRecommended30 DaysSolution for injection. Clear, colourless,…A10AD06insulin degludec and insulin aspartNovo Nordisk A/SNovo Alle DK-2880 Bagsvaerd DenmarkKRIN@novonordisk.comNOVO NORDISK A/SNOVO ALLE DK-2880 BAGSVAERD DENMARKRegisteredValid
8DAWA LTD13113LEVOCET -M TabletHumanLocalLevocetirizine hydrochloride and Montelukast…Each film coated tablet contains:Levocetirizine…H2020/CTD6847/13113Film-Coated TabletORALRecommended24 monthsWhite ,circular biconvex shaped film coated…R03DC53montelukast combinationsDAWA LIMITEDP.O BOX 16633-00620admin@dawalimited.comDAWA LTDPLOT NO. 7879/8, BABA DOGO RD, RUARAKA, NAIROBIRegisteredValid
9LAZOR PHARMACEUTICALS LIMITED13226INSTGRAHumanForeignDolutegravir SodiumDolutegravir Sodium Equivalent to Dolutegravir…H2020/CTD6868/13226TabletORALRecommended24 monthsJ05AX12dolutegravirEmcure Pharmaceuticals Limitedt-184 M.I.D.C Bhosari, Pune IndiaSanjeeva.Menonl@emcure.co.inEMCURE PHARMACEUTICALS LTD (ORAL DOSAGE DIVISION)PLOT NO. P-2, ITBT PARK, PHASE II, MIDC,…RegisteredValid
10DAWA LTD14828EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE…HumanForeignEmtricitabine and Tenofovir Disoproxil FumarateEmtricitabine 200 mg and Tenofovir Disoproxil…H2020/CTD7616/14828Film-Coated TabletORALRecommended24 monthsBlue colored, capsule shaped, film-coated…J05AR03tenofovir disoproxil and emtricitabineLAURUS LABS LIMITED2nd Floor, Serene Chambers, Road No.-7 Banjara…info@lauruslabs.comLAURUS LABS LIMITEDPLOT NO. 19, 20 & 21, WESTERN SECTOR, APSEZ,…RegisteredValid
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