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Products Suspended, Withdrawn or Revoked

#Local Technical RepresentativeApplication NumberProduct Trade NameHuman VetLocal ForeignInn Of ApiApi Strength Per DosageProduct Registration NoDosage Form NameRoutes NameShelf Life NameProduct Visual DescAtc Code NamePharmacotherapeutic GroupMah Company NameMah Company AddressMah Company EmailSite NameSite AddressStatus NameStatus DescriptionGmp Status
1SURGIPHARM LTD221Atrovent 20 HFAHumanForeignIpratropium bromideIpratropium bromide corresponding to ipratropium…9000Pressurised InhalationRESPIRATORY (INHALATION)24 monthsClear, colourless solution in aluminium canister…R03BBOther drugs for obstructive airway diseases…Boehringer Ingelheim international GmbHBinger StraBe 173 55216 Ingelheim am Rhein Germanyinfo@boehringer-ingelheim.deBoehringer Ingelheim Pharma GmbH & Co. KG,173 Binger Strasse, 55216, Ingelheim am Rhein,…WithdrawnInitiated by the clientGMP Site is Invalid
2NVS KENYA LTD263Baneocin PowderForeignBacitracin+NeomycinBACITRACIN ZINC+NEOMYCIN SULPHATE PWD 250 IU +…1315Powder And Solvent For Cutaneous SolutionTOPICAL36 monthsBaneocin powder is a fine white to yellowish…D06AXOther antibiotics for topical useSandoz GmbH KundlBiochemiestrasse 10A-6250 Kundl / TirolAustria.winnie.munene@sandoz.comMONTAVIT GES. MBHSALZBERGSTR. 96, A-6067 ABSAM, AUSTRIAWithdrawnInitiated by the clientGMP Site is Invalid
3SURGIPHARM LTD307Atrovent 500 mcg UDVHumanForeignIpratropium bromide0.5 mg ipratropium bromide (anhydrous) per 2 ml…10090; H95/139Inhalation Vapour, SolutionRESPIRATORY (INHALATION)24 monthsClear, colourless or almost colourless solutionR03BBOther drugs for obstructive airway diseases…Boehringer Ingelheim international GmbHBinger StraBe 173 55216 Ingelheim am Rhein Germanyinfo@boehringer-ingelheim.deLABORATOIRE UNITHER80084 AMIENS CEDEX, FRANCEWithdrawnInitiated by the clientGMP Site is Invalid
4PHILLIPS THERAPEUTICS LIMITED590GLURENORForeignGliquidone30 mg9711TabletORAL48 monthsFlat round white bevel-edged tablets scored on…A10BBBlood glucose lowering drugs excluding insulins:…Laboratori Guidotti S.p.A.Via Livornese 897 56122- La Vettola Pisa Italyprijli@menarini.itA. Menarini Manufacturing Logistics and Services…Via Campo di Pile, 67100 L Aquila ItalyWithdrawnInitiated by the clientGMP Site Approved
5SURGIPHARM LTD1014Jentadueto 2,5 mg/850 mg TabletsForeignLinagliptin & Metformin HCl2,5 mg & 850 mg/film-coated tabletH2013/CTD1294/345Film-Coated TabletORAL24 monthsJENTADUETO 2,5 mg/850 mg film-coated tablets are…A10BDCombinations of oral blood glucose lowering drugs Boehringer Ingelheim international GmbHBinger StraBe 173 55216 Ingelheim am Rhein Germanyinfo@boehringer-ingelheim.deBoehringer Ingelheim Pharma GmbH & Co. KG,173 Binger Strasse, 55216, Ingelheim am Rhein,…WithdrawnInitiated by the clientGMP Site is Invalid
6SURGIPHARM LTD1100METALYSE 8 000 U and SolventHumanForeignTenecteplaseTenecteplase 8 000 units. The reconstituted…15128Powder And Solution For Solution For InjectioINTRAVENOUS DRIP24 monthsPowder for IV infusion: white to pale yellow…B01ADAntithrombotic agents: Enzymes Ingelheim Pharmaceuticals (Pty) Ltd404 Main Avenue Ferndale Randburg South Africafiona.smith@boehringer-ingelheim.comBoehringer Ingelheim Ellas A.E (Koropi Plant)5th KM Paiania-Markopoulo, Koropi Attiki, 19400,…WithdrawnInitiated by the clientGMP Site Approved
7SURGIPHARM LTD1133Mobic 15 mg/1.5 ml AmpoulesHumanForeignMeloxicam15 mg/1,5 ml15127; H2004/004Solution For InjectionINTRAMUSCULAR36 monthsClear yellow solution with a green tinge,…M01ACNon-steroidal…Boehringer Ingelheim international GmbHBinger StraBe 173 55216 Ingelheim am Rhein Germanyinfo@boehringer-ingelheim.deBOEHRINGER INGELHEIM ESPANA S.APRAT DE LA RIBA 50, 08174 SANT CUGAT DEL VALLES,…WithdrawnInitiated by the clientGMP Site is Invalid
8PHILLIPS THERAPEUTICS LIMITED1136SCHERIPROCTForeignPrednisolone hexanoate / Cinchocain HCl1 suppository contains: Prednisolone caproate 1.3…4125SuppositoryRECTAL30 Daysyellowish-white suppositoryD07XAOther Combinations of Weak Corticosteroids for…Bayer Pharma AGBayer Pharma AG 13342 Berlin Germanywww.bayer.comBayer Health Care Manufacturing s.r.l. SegrateVia E. Schering 21, 20090, Segrate (Milano), ItalyWithdrawnInitiated by the clientGMP Site Approved
9STATIM PHARMACEUTICALS LTD1289Vancocin CP 500ForeignVancomycin Hydrochlorideone vial contains vancomycin hydrochloride…7116InjectionINTRAVENOUS24 monthsa 10ml size vial sealed with a rubber stopper and…J01XAAntibacterials for systemic use:…Eli Lilly and Company16ch.Des Conquelicots P.O Box 580 CH-1214…moodleyan@lilly.comVIANEX S.A. /PLANT C16th Km Marathonos Avenue, 15351 Pallini, Attica,…SuspendedRegulatory decisionGMP Site is Invalid
10ENERGIA PHARMA LIMITED1445Artesiane 20HumanForeignArtemetherArtemether 20mg/ml13634Solution For InjectionINTRAMUSCULAR36 monthsClear colourless to slightly yellowish oily…P01BEAntimalarial Antiprotozoals: Plain Artemisininand…Dafra Pharma GmbHWeidboden 2714618 BoningenSwitzerlandinfo@dafrapharma.comRotexmedica GmbHBunsenstrasse 4 22940 Trittau GermanyWithdrawnInitiated by the clientGMP Site Approved
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