Transcription of FINISHED DOSAGE FORMS, DOSSIERS READY - …
1 Flavine Europe GmbHGrillparzerstra e 1681675 Munich, GermanyTel.: +49 (0) 89 939 967-0E-mail: NAMEGALENIC FORMDOSAGE / STRENGTHMA STATUSA carboseGlucobay tablet50, 100mgNationally approvedGlutathione-vial600, 1200mgUnder registrationTramadol + ParacetamolZaldiar / 325mgDCP approved Tramadol + ParacetamolZaldiar efferescent / 325mg Dossier READY for filingFosfomycin trometamolMonuril sachet3gNationally approvedImipenem + CilastatinTienam vial250 / 250mg, 500 / 500mg powder for injectionNationally approvedMeropenemMeropen vial500, 1000mg powder for injectionUnder registrationDesloratadineAerius tablet5mgDCP approvedAzithromycin dihydrateZithromax dispersible tablet250, 500mgNationally approvedMethylprednisolone Urbason tablet4, 16mgDossier READY for filingMethylprednisolone sodium succinateSolu-Medrol 1 powder + 1 solvent ampoule20, 40, 120mg / 500mg only for hospital use.
2 Without solventNationally approvedFludarabine phosphate injFludara vial50mg powder for injection Under registrationAmiodarone Cordarone tablet200mgNationally approvedClopidogrel bisulfatePlavix film coated tablet75mgDCP approvedValsartanDiovan film coated tablet40, 80, 160, 320mgDCP approvedValsartan + HCTZD iovan tablet80 , 160 , 160mg/25mgDossier READY for filingAdemetionine (SAMe)Samyr vial400mgUnder registrationEscitalopramCipralex tablet5, 10, 20mgUnder registrationPidobenzoneK5 Lipogeltopical cream4%Nationally approved as OTC/MD (anti-brown spots)OxytocinSyntocinon solution for injection5 IU/mlDossier READY for filingFINISHED DOSAGE FORMS, DOSSIERS READY - FLAVINE EUROPEA nalgesicsAntibioticsAntihistaminesHormon esAlimentary tract and metabolismAnti-infectives / Anti-inflammatoriesCardiovascular systemCentral Nervous SystemAntineoplasticsDermatologyFlavine Europe GmbHGrillparzerstra e 1681675 Munich, GermanyTel.
3 : +49 (0) 89 939 967-0E-mail: NAMEGALENIC FORMDOSAGE / STRENGTHDOSSIER READYB ortezomibpowder for injection1, acetateCancidas powder for injection50, 70mgQ3/2014 Darifenacin SREmselex SR mgQ4/2014 DuloxetineEC capsule20, 30, 60mgQ3/2014 EntecavirBaraclude film coated , 1mgQ1/2015 Fludarabine phosphate oralFludara hard gelatine capsule10mgDossier READY , BE requ'dFoscarnetFoscavir 250mlQ1/2014 PaliperidoneInvega XR , 3, 6, 9mgQ2/2015 Paracetamol + ascorbic acid + phenylephrineSachet600mg Paracetamol, 10mg phenylephrine, 40mg ascorbic acdQ4/2013 PemetrexedAlimta powder for injection100mg, 500mgQ4/2014 PregabalinLyrica capsule25, 50, 75, 100, 150, 200, 225, 300mgQ4/2014 TigecyclineTigacyl powder for injection50mgQ4/2014 VoriconazoleVfend powder for injection200mgQ4/2015 VoriconazoleVfend tablet50.
4 200mgQ2/2014 FINISHED DOSAGE FORMS, DOSSIERS IN DEVELOPMENT - FLAVINE EUROPED isclaimerSome of the products listed are currently under development and therefore pertinent information may not be available at this time. Any product listed which is covered under current patents is available only for use reasonably related to the development and submission of information to the relevant Health Authorities (including the US FDA) to the extent permitted under applicable laws regulating the manufacture, use and sale of Active Pharmaceutical Ingredients and/or their 2013 Flavine Europe GmbH, Grillparzerstr. 16, 81675 Munich, Germany | Tel.: +49 89 939967-0 | Fax.: +49 89 939967-19 | |
