Final Belgian list: (Last update 07/02/2014) marketing name Active substance MAH Reason on list ADCETRIS BRENTUXIMAB VEDOTINE TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD, Cond Auth, ALDURAZYME LARONIDASE GENZYME EUROPE B.V. Auth under excep circumstances, AMYVID FORBETAPIR (F-18) Q.S. ELI LILLY NEDERLAND BV ARZERRA OFATUMUMAB 20.00 MG/ML GLAXO GROUP LTD Conditional auth, ATRIANCE NELARABINE 5.00 MG/ML GLAXO GROUP LTD Auth under excep circumstances ATRYN ANTITHROMBIN ALFA GTC BIOTHERAPEUTICS UK LIMITED Auth under excep circumstances, AUBAGIO TERIFLUNOMIDE SANOFI-AVENTIS GROUPE BENLYSTA BELIMUMAB GLAXO GROUP LTD BETMIGA MIRABEGRON ASTELLAS PHARMA EUROPE B.V. BEXSERO NEISSERIA MENINGITIDES B, RECOMBINANT, COMPONENT, ADSORBED Q.S. NOVARTIS VACCINES & DIAGNOSTICS S.R.L. BINDREN COLESTILAN NOVARTIS VACCINES & DIAGNOSTICS S.R.L. BOSULIF BOSUTINIB (MONOHYDRATE) 100.00 MG PFIZER LIMITED, Cond Auth, BRETARIS GENUAIR ACLIDINIUM (BROMURE) ALMIRALL S.A, BRINTELLIX VORTIOXETINE H. LUNDBECK A/S CAPRELSA VANDETANIB ASTRAZENECA AB, Cond Auth CEPLENE HISTAMINE DIHYDROCHLORIDE MEDA AB Auth under excep circumstances CHAMPIX VARENICLINE (TARTRATE) PFIZER LIMITED CHLOE MITHRA PHARMACEUTICALS S.A. CINRYZE C1-INHIBITOR 500.00 IU VIROPHARMA BVBA CLAUDIA - 35 SANDOZ N.V. CLEVIPREX CLEVIDIPINE BUTYRATE THE MEDICINES COMPANY UK LTD CONSTELLA LINACLOTIDE ALMIRALL S.A CUPRYMINA COPPER (64-CU) CHLORIDE Q.S. SPARKLE S.R.L DACOGEN DECITABINE JANSSEN-CILAG INTERNATIONAL NV DALIRESP ROFLUMILAST 500.00 MCG NYCOMED GMBH DAPHNE MITHRA PHARMACEUTICALS S.A. DAXAS ROFLUMILAST NYCOMED GMBH DEFITELIO DEFIBROTIDE??? New biological, authorised under exceptional circumstances DIACOMIT STIRIPENTOL BIOCODEX Conditional auth
DIANE-35 BAYER N.V. DIFICLIR FIDAXOMICIN ASTELLAS PHARMA EUROPE B.V. EDARBI AZILSARTAN MEDOXOMIL (POTASSIUM) TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD EDURANT RILPIVIRINE (HYDROCHLORIDE) JANSSEN-CILAG INTERNATIONAL NV EKISTOL CILOSTAZOL??? Outcome Referral Art 31, EKLIRA GENUAIR ACLIDINIUM (BROMURE) ALMIRALL S.A., ELAPRASE IDURSULFASE SHIRE HUMAN GENETIC THERAPIES AB Auth under excep circumstances ELIQUIS APIXABAN BRISTOL MYERS SQUIBB/PFIZER EEIG ELISAMYLAN 35 MYLAN BVBA/SPRL ELVANSE / TYVENSE LISDEXAMPHETAMINE BRYSTOL MYERS SQUIBB/ PFIZER EEIG ENUREV BREEZHALER GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED, ERIVEDGE VISMODEGIB ROCHE REGISTRATION LIMITED, Cond Auth ESBRIET PIRFENIDONE INTERMUNE EUROPE LTD, EURARTESIM PIPERAQUINE TETRAPHOSPHATE (TETRAHYDRATE), DIHYDROARTEMISININ (DHA) SIGMA-TAU INDUSTRIE FARMAC. RIUNITE SPA, EVARREST FIBRINOGEN, HUMAN Q.S., THROMBIN, HUMAN Q.S. OMRIX BIOPHARMACEUTICALS N.V. EVIPLERA ENOFOVIR DISOPROXIL (FUMARATE), EMTRICITABINE, RILPIVIRINE (HYDROCHLORIDE) GILEAD SCIENCES LTD EVOLTRA CLOFARABINE GENZYME EUROPE B.V. Auth under excep circumstances EXJADE DEFERASIROX NOVARTIS EUROPHARM LIMITED EYLEA AFLIBERCEPT BAYER AG FAMPYRA FAMPRIDINE BIOGEN IDEC LTD, Cond Auth FIRDAPSE AMIFAMPRIDINE (PHOSPHATE) BIOMARIN EUROPE LTD Auth under excep circumstances, FLUENZ INFLUENZA VIRUS, LIVE, ATTENUATED Q.S. MEDIMMUNE LLC FLUENZ TETRA INFLUENZA VIRUS (LIVE, ATTENUATED Q.S., NASAL) MEDIMMUNE LLC FORXIGA DAPAGLIFLOZIN (PROPANEDIOL MONOHYDRATE) BRISTOL MYERS SQUIBB/ASTRAZENECA EEIG FYCOMPA PERAMPANEL EISAI EUROPE LTD GILENYA FINGOLIMOD (HYDROCHLORIDE) 0.50 MG NOVARTIS EUROPHARM LIMITED, GIOTRIF AFATINIB??? GLYBERA ALIPOGENE TIPARVOVEC Q.S. UNIQURE BIOPHARMA B.V, Auth under excep circumstances, GRASTOFIL FILGASTRIM???
GRATIELLA 35 3DDD PHARMA N.V. HALAVEN ERIBULIN (MESYLATE) 0.44 MG/ML EISAI LIMITED HEXACIMA Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rdna), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine SANOFI PASTEUR SA (adsorbed) HEXYON Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rdna), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed) SANOFI PASTEUR MSD HIZENTRA IMMUNOGLOBULIN HUMAN NORMAL 200.00 MG/ML BIOCLS GMBH HYQVIA IMMUNOGLOBULIN HUMAN NORMAL 100.00 MG/ML BAXTER INNOVATIONS GMBH ICLUSIG PONATINIB (HYDROCHLORIDE) ARIAD PHARMA LTD ILARIS CANAKINUMAB NOVARTIS EUROPHARM LIMITED Auth under excep circumstances, IMNOVID (POMALIDOMIDE CELGENE) IMVANEX POMALIDOMIDE CELGENE EUROPE LIMITED, Modified Vaccinia Ankara virus - Bavarian Nordic (MVA-BN) live virus BAVARIAN NORDIC A/S INCIVO TELAPREVIR JANSSEN-CILAG INTERNATIONAL NV, Auth under excep circumstances INCRELEX MECASERMIN IPSEN PHARMA Auth under excep circumstances, INCRESYNC Alogliptin/pioglitazone??? INFLECTRA NFLIXIMAB HOSPIRA UK LTD INFLUSPLIT TETRA Influenza virus inactivated split virion GLAXO GROUP LTD Biological INLYTA AXITINIB PFIZER LIMITED INVIRASE SAQUINAVIR (MESILATE) ROCHE REGISTRATION LIMITED INVOKANA Canagliflozin Janssen-Cilag International N.V. IOA MERCK SHARP & DOHME NOMOGESTROL ACETATE / ESTRADIOL HEMIHYDRATE IPREZIV AZILSARTAN MEDOXOMIL (POTASSIUM) TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD JAKAVI RUXOLITINIB (PHOSPHATE) NOVARTIS EUROPHARM LIMITED, JAYDESS LEVONORGESTREL 13.50 MG BAYER N.V. JENTADUETO METFORMIN HYDROCHLORIDE, LINAGLIPTIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH
JETREA OCRIPLASMIN THROMBOGENICS NV JEVTANA CABAZITAXEL SANOFI-AVENTIS GROUPE KADCYLA Trastuzumab emtansine Roche Registration Ltd KALYDECO IVACAFTOR VERTEX PHARMACEUTICALS LIMIT, KRYSTEXXA PEGLOTICASE SAVIENT PHARMA IRELAND LIMITED, LACTEST GASILOXE Lactest S.L. / Venter Pharma S.L. LEMTRADA ALEMTUZUMAB GENZYME THERAPEUTICS LTD LIBERTEK ROFLUMILAST NYCOMED GMBH LOJUXTA LOMITAPIDE (MESYLATE) AEGERION PHARMACEUTICALS, Auth under excep circumstances LONQUEX LIPEGFILGRASTIM TEVA PHARMA BV, LYXUMIA LIXISENATIDE SANOFI-AVENTIS GROUPE MACI CHONDROCYTES, AUTOLOGOUS CULTURED Q.S. GENZYME EUROPE B.V. NAGLAZYME GALSULFASE BIOMARIN EUROPE LTD Auth under excep circumstances, NEXOBRID PROTEOLYTIC ENZYMES (CONCENTRATE) ENRICHED IN BROMELAIN TEVA PHARMA GMBH, NIMENRIX NEISSERIA MENINGITIDES A+C+W+Y, POLYSACCHARIDE CONJ. TO TETANUS TOXOID Q.S. GLAXOSMITHKLINE BIOLOGICALS S.A., NOVOEIGHT Turoctocog alfa NOVO NORDISK A/S NOVOTHIRTEEN CATRIDECACOG NOVO NORDISK A/S NULOJIX BELATACEPT BRISTOL-MYERS SQUIBB PHARMA EEIG OPGENRA EPTOTERMIN ALFA OLYMPUS BIOTECH LTD OPSUMIT MACITENTAN Actelion Registration Ltd OPTIMARK GADOVERSETAMIDE MALLINCKRODT MEDICAL GMBH ORPHACOL CHOLIC ACID LABORATOIRES CTRS Auth under excep circumstances OSSEOR STRONTIUM RANELATE SERVIER, LES LABORATOIRES OVALEAP FOLLITROPIN ALPHA??? PANDEMRIX INFLUENZA VIRUS (INACTIVATED) Q.S. GLAXOSMITHKLINE BIOLOGICALS S.A. PERJETA PERTUZUMAB ROCHE REGISTRATION LIMITED PICATO INGENOL MEBUTATE LEO PHARMA A/S PIXUVRI PIXANTRONE (DIMALEATE) CTI LIFE SCIENCES LTD, Cond Auth PLETAL CILOSTAZOL??? Outcome Referral Art 31, PRIALT ZICONOTIDE (ACETATE) EISAI LIMITED Auth under excep circumstances, PROTELOS STRONTIUM RANELATE SERVIER, LES LABORATOIRES
PROVENGE AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS ACTIVATED WITH PAP-GM-CS Q.S. DENDREON UK LIMITED, RELVAR ELLIPTA Fluticasone furoate/vilanterol trifenatate Glaxo Group Ltd, REMSIMA INFLIXIMAB CELLTRION HEALTHCARE HUNGARY KFT. REPLAGAL AGALSIDASE ALFA SHIRE HUMAN GENETIC THERAPIES AB Auth under excep circumstances, REVESTIVE TEDUGLUTIDE NYCOMED DANMARK APS, RIENSO FERUMOXYTOL TAKEDA PHARMA A/S RYZODEG INSULIN ASPART 30.00 UML, INSULIN DEGLUDEC 70.00 UML NOVO NORDISK A/S SEEBRI BREEZHALER GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED, SELINCRO NALMEFENE (HYDROCHLORIDE DIHYDRATE) LUNDBECK A/S SIGNIFOR PASIREOTIDE (DIASPARTATE) NOVARTIS EUROPHARM LIMITED SOMATROPIN BIOPARTNERS SOMATROPIN BIOPARTNERS SOVALDI SOFOSBUVIR Gilead Sciences International Limited SPEDRA AVANAFIL VIVUS BV STIVARGA REGORAFENIB BAYER AG STRIBILD TENOFOVIR DISOPROXIL (FUMARATE), EMTRICITABINE, ELVITEGRAVIR, COBICISTAT GILEAD SCIENCES LTD TAFINLAR DABRAFENIB GLAXOSMITHKLINE TRADING SERVICES LIMITED TEYSUNO TEGAFUR, GIMERACIL, OTERACIL (MONOPOTASSIUM) NORDIC GROUP BV, TIVICAY DOLUTEGRAVIR ViiV Healthcare UK Limited TOVANOR BREEZHALER GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED, TRAJENTA LINAGLIPTIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH TRESIBA INSULIN DEGLUDEC NOVO NORDISK A/S TROBALT RETIGABINE GLAXO GROUP LTD TYBOST COBICISTAT??? TYGACIL TIGECYCLINE PFIZER LIMITED TYSABRI NATALIZUMAB BIOGEN IDEC LTD TYVERB LAPATINIB (DITOSYLATE MONOHYDRATE) GLAXO GROUP LTD Conditional auth ULTIBRO BREEZHALER INDACATEROL (MALEATE) 85.00 MCG/DO, GLYCOPYRRONIUM (BROMIDE) 43.00 MCG/DO NOVARTIS EUROPHARM LIMITED VECTIBIX PANITUMUMAB 20.00 MG/ML AMGEN EUROPE BV Conditional auth
VEDROP TOCOPHEROL D-ALPHA (AS TOCOFERSOLAN) ORPHAN EUROPE SARL Auth under excep circumstances, VEPACEL INFLUENZA VIRUS (INACTIVATED) Q.S. BAXTER INNOVATIONS GMBH VICTRELIS BOCEPREVIR MERCK SHARP & DOHME LTD VIPDOMET ALOGLYPTIN / METFORMIN??? VIPIDIA ALOGLYPTIN??? VITEKTA Elvitegravir Gilead Sciences International Ltd VONCENTO FACTOR VIII HUMAN 1000.00 IU, FACTOR VON WILLEBRAND 2400.00 IU TEVA PHARMA BV VOTUBIA EVEROLIMUS NOVARTIS EUROPHARM LIMITED Conditional auth VYNDAQEL TAFAMIDIS (MEGLUMINE) PFIZER LIMITED Auth under excep circumstances, New AS, XAGRID XAGRID SHIRE PHARMACEUTICAL CONTRACTS LTD Auth under excep circumstances XALKORI CRIZOTINIB PFIZER LIMITED, Cond Auth XARELTO RIVAROXABAN 10.00 MG BAYER SCHERING PHARMA AG XGEVA DENOSUMAB AMGEN EUROPE BV New biological XIAPEX COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM UK LIMITED XIGDUO DAPAGLIFLOZIN/METFORMIN Bristol-Myers Squibb/AstraZeneca EEIG XOFIGO Radium Ra 223 dichloride Bayer Pharma AG XOTERNA BREEZHALER INDACATEROL / GLYCOPYRRONIUM TEVA PHARMA BV XTANDI ENZALUTAMIDE ASTELLAS PHARMA EUROPE B.V. YELLOX BROMFENAC (SODIUM SESQUIHYDRATE) CROMA-PHARMA GMBH YERVOY IPILIMUMAB BRISTOL-MYERS SQUIBB PHARMA EEIG, YONDELIS TRABECTEDIN PHARMA MAR SA Auth under excep circumstances ZALTRAP AFLIBERCEPT SANOFI-AVENTIS GROUPE ZELBORAF VEMURAFENIB ROCHE REGISTRATION LIMITED ZINFORO CEFTAROLINE FOSAMIL (ACETIC ACID SOLVATE MONOHYDRATE) ASTRAZENECA AB ZOELY THERAMEX S.r.l. NOMOGESTROL ACETATE / ESTRADIOL HEMIHYDRATE ZYTIGA ABIRATERONE ACETATE JANSSEN-CILAG INTERNATIONAL NV NOTE In Red in Black commercialised / commercialisé / gecommercialiseerd not commercialised / pas commercialisé / niet gecommercialiseerd
in blue in grey Conditional auth Auth under excep circumstances info not yet available / info non disponible / info niet beschikbaar New addition of this month / nouvelle addition de ce mois / nieuwe toevoeging van deze maand nouvelle substance active / nieuw actief bestanddeel nouveau médicament biologique / nieuwe biologische geneesmiddel Etude de sécurité post-autorisation / post-autorisatie veiligheidsstudies Autorisé sous certaines conditions / vergund onder bepaalde voorwaarden autorisé sous circonstances exceptionnelles / vergund onder uitzonderlijke omstandigheden Product informations / informations sur les produits / produkten informaties informations sur les produits/productinformatie http://www.fagg-afmps.be/search?language=fr&search_field=notice