docFinal Belgian list
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Final Belgian list
Final Belgian list: (Last update 14/04/2016) marketing name Active substance ABASAGLAR (ABASRIA previously) INSULINE GLARGINE ACCOFIL FILGASTRIM ADCETRIS BRENTUXIMAB VEDOTINE ADEMPAS RIOCIGUAT AKYNZEO NETUPITANT, PALONOSETRON ALBUMEON HUMAN ALBUMIN ALPHA-RIX TETRA INFLUENZA VACCINE INACTIVATED AMITIZA LUBIPROSTON AMYVID FORBETAPIR (F-18) Q.S. MAH ELI LILLY REGIONAL OPERATIONS GMBH ACCORD HEALTHCARE LIMITED TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD BAYER PHARMA HELSINN BIREX PHARMACEUTICALS LTD ? GLAXOSMITHKLINE BIOLOGICALS S.A. Sucampo Pharma Europe Ltd ELI LILLY NEDERLAND BV Reason on list New Biological New Biological New AS, Cond Auth, PASS New AS New AS New biological New Biological New AS New AS ANORO GLAXO GROUP LTD New AS, PASS BAYER PHARMA AG GLAXO GROUP LTD GTC BIOTHERAPEUTICS UK LIMITED SANOFI-AVENTIS GROUPE GEDEON RICHTER Plc FINOX Biotech AG SAMSUNG BIOEPSIS UK Limited GLAXO GROUP LTD ASTELLAS PHARMA EUROPE B.V. PASS Auth under excep circumstances Auth under excep circumstances, PASS New AS Outcome Referral Art 31, PASS New biological New Biological New AS New AS NOVARTIS VACCINES & DIAGNOSTICS S.R.L. New AS AMGEN EUROPE BV PFIZER LIMITED ALMIRALL S.A New AS, conditional auth New AS, Cond Auth, PASS New AS, PASS ALMIRALL S.A New AS, PASS H. LUNDBECK A/S UCB Pharma S.A. ASTRAZENECA AB MEDA AB GENZYME EUROPE B.V. PFIZER LIMITED New AS New active substance New AS, Cond Auth Auth under excep circumstances New AS, PASS PASS APLEEK ATRIANCE ATRYN AUBAGIO BELLINA BEMFOLA BENEPALI BENLYSTA BETMIGA BEXSERO BLINCYTO BOSULIF BRETARIS GENUAIR BRIMICA GENUAIR BRINTELLIX BRIVIACT CAPRELSA CEPLENE CERDELGA CHAMPIX UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE ETHINYL ESTRADIOL/GESTODENE NELARABINE 5.00 MG/ML ANTITHROMBIN ALFA TERIFLUNOMIDE CHLORMADINONE, ETHINYLESTRADIOL Follitropin alfa ETANERCEPT BELIMUMAB MIRABEGRON NEISSERIA MENINGITIDES B, RECOMBINANT, COMPONENT, ADSORBED Q.S. BLINATUMOMAB BOSUTINIB (MONOHYDRATE) 100.00 MG ACLIDINIUM BROMIDE ACLIDINIUM BROMIDE/ FORMOTERL FUMARATE DIHYDRATE VORTIOXETINE BRIVARACETAM VANDETANIB HISTAMINE DIHYDROCHLORIDE ELIGLUSTAT VARENICLINE (TARTRATE) CINRYZE VIROPHARMA BVBA PASS SANDOZ N.V. PASS THE MEDICINES COMPANY UK LTD CSL BEHRING GmbH TMC Pharma Services Ltd ALMIRALL S.A TAKEDA BELGIUM SERVIER, LES LABORATOIRES NOVARTIS EUROPHARM LIMITED ROCHE REGISTRATION LIMITED BIO PRODUCTS LABRATORY LTD BASILEA MEDICAL LTD SPARKLE S.R.L ELI LILLY NEDERLAND BV JANSSEN-CILAG INTERNATIONAL NV BRISTOL MYERS SQUIBB/PFIZER EEIG NYCOMED GMBH New AS New Biological New AS, Cond Auth New AS PASS PASS New AS New AS New Biological New AS New AS New AS New AS New AS PASS MITHRA PHARMACEUTICALS S.A. PASS DAXAS C1-INHIBITOR 500.00 IU ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG CLEVIDIPINE BUTYRATE HUMAN FACTOR VIII CABOZANTINIB LINACLOTIDE VALPROIC ACID IVABRADINE SECUKINUMAB COBIMETINIB HUMAN COAGULATION FACTOR X ISAVUCONAZOLE COPPER (64-CU) CHLORIDE Q.S. RAMUCIRUMAB DECITABINE DACLATASVIR ROFLUMILAST 500.00 MCG ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG ROFLUMILAST NYCOMED GMBH DEFITELIO DEFIBROTIDE Gentium DELTYBA DEPAKINE DEPAKINE CHRONO DEPAKINE CHRONO DEPAKINE ENTERIC DEPAKINE IV DELAMANID SODIUM VALPROATE SODIUM VALPROATE, VALPROIC ACID SODIUM VALPROATE, VALPROIC ACID SODIUM VALPROATE SODIUM VALPROATE ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG FIDAXOMICIN DOMPERIDONE MALEATE DOMPERIDONE MALEATE DOMPERIDONE MALEATE Otsuka Novel Products GmbH SANOFI BELGIUM SANOFI BELGIUM PI-PHARMA NV SANOFI BELGIUM SANOFI BELGIUM PASS New biological, authorised under exceptional circumstances New AS, Cond Auth PASS PASS PASS PASS PASS BAYER N.V. PASS ASTELLAS PHARMA EUROPE B.V. MYLAN SPRL TEVA PHARMA BELGIUM N.V. EUROGENERICS N.V. New AS PASS PASS PASS CLAUDIA - 35 CLEVIPREX CLUVOT COMETRIQ CONSTELLA CONVULEX CORLENTOR COSENTYX COTELLIC COAGADEX CRESEMBA CUPRYMINA CYRAMZA DACOGEN DAKLINZA DALIRESP DAPHNE DIANE-35 DIFICLIR DOMPERIDON MYLAN DOMPERIDON TEVA DOMPERIDONE EG DOMPERIDONE INSTANT DOMPERIDONE EG DOMPERIDONE MYLAN DOMPERIDONE MALEATE DOMPERITOP DOMPERIDONE MALEATE ACLIDINIUM BROMIDE/ FORMOTERL FUMARATE DUAKLIR GENUAIR DIHYDRATE EBYMECT DAPAGLIFLOZIN/METFORMIN EDARBI AZILSARTAN MEDOXOMIL (POTASSIUM) EDISTRIDE DAPAGLIFLOZIN EDURANT RILPIVIRINE (HYDROCHLORIDE) EKLIRA GENUAIR ACLIDINIUM (BROMURE) ELAPRASE IDURSULFASE ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ELISAMYLAN 35 ACETATE 2.00 MG ELOCTA EFMOROCTOCOG ALFA ELVANSE / TYVENSE LISDEXAMPHETAMINE ENTRESTO SACUBITRIL/ VALSARTAN ENTYVIO VEDOLIZUMAB ENUREV BREEZHALER GLYCOPYRRONIUM (BROMIDE) EPERZAN ALBIGLUTIDE EPISALVAN BIRCH BARK EXTRACT ERIVEDGE VISMODEGIB ESBRIET PIRFENIDONE PIPERAQUINE TETRAPHOSPHATE (TETRAHYDRATE) , EURARTESIM DIHYDROARTEMISININ (DHA) EVARREST EVIPLERA EVOLTRA EVOTAZ EXJADE EXVIERA EYLEA EZICLEN EUROGENERICS N.V. PASS MYLAN BVBA/SPRL APOTEX NV PASS PASS ALMIRALL S.A PASS ASTRAZENECA AB TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD ASTRAZENECA AB JANSSEN-CILAG INTERNATIONAL NV ALMIRALL S.A. SHIRE HUMAN GENETIC THERAPIES AB New AS New AS New AS New AS New AS, PASS Auth under excep circumstances MYLAN BVBA/SPRL PASS BIOGEN IDEC LTD BRYSTOL MYERS SQUIBB/ PFIZER EEIG NOVARTIS EUROPHARM LIMITED TAKEDA PHARMA A/S NOVARTIS EUROPHARM LIMITED GlaxoSmithKline Trading Services Limited Birken AG ROCHE REGISTRATION LIMITED INTERMUNE EUROPE LTD New AS New AS New AS New AS New AS, PASS New AS New AS New AS, Cond Auth New AS, PASS SIGMA-TAU INDUSTRIE FARMAC. RIUNITE SPA New AS, PASS FIBRINOGEN, HUMAN Q.S., THROMBIN, HUMAN Q.S. OMRIX BIOPHARMACEUTICALS N.V. ENOFOVIR DISOPROXIL (FUMARATE) , EMTRICITABINE , RILPIVIRINE (HYDROCHLORIDE) CLOFARABINE ATAZANAVIR/COBICISTAT DEFERASIROX DASABUVIR AFLIBERCEPT SULPHATE ANHYDROUS, MAGNESIUM SULFATE HEPTAHYDRATE, POTASSIUM SULPHATE New Biological GILEAD SCIENCES LTD New AS GENZYME EUROPE B.V. Bristol-Myers Squibb Pharma Eeig NOVARTIS EUROPHARM LIMITED ABBVIE LTD BAYER AG Auth under excep circumstances New AS PASS New AS New AS IPSEN PHARMA PASS FAMPYRA FARYDAK FERCAYL FERTINORM KIT FEXERIC FIRDAPSE FLUENZ TETRA FORXIGA FYCOMPA FAMPRIDINE BIOGEN IDEC LTD Panobinostat Novartis Europharm limited IRON DEXTRAN NON NUMERICAL AMOUNT LABORATORIA STEROP NV Gonadotrophin Postmenopausal (HMG) Non NumericalLaboratoires Amount quantum Genévrier satis SA FERRIC CITRATE COORDINATION COMPLEX KERYX BIOPHARMA UK LTD AMIFAMPRIDINE (PHOSPHATE) BIOMARIN EUROPE LTD INFLUENZA VIRUS (LIVE, ATTENUATED Q.S., NASAL) MEDIMMUNE LLC DAPAGLIFLOZIN (PROPANEDIOL MONOHYDRATE) BRISTOL MYERS SQUIBB/ASTRAZENECA EEIG PERAMPANEL EISAI EUROPE LTD New AS, Cond Auth New AS PASS New Biological New AS, PASS Auth under excep circumstances, PASS New AS New AS New AS GALLIAPHARM Germanium (68Ge) chloride / gallium (68Ga) chloride ECKERT & ZIEGLER RADIOPHARM GMBH New AS GEONISTIN GILENYA GIOTRIF GLIVEC HUMAN PAPILLOMAVIRUS 9-VALENT (recombinant, adsorbed) OBINUTUZUMAB ELVITEGRAVIR/ COBICISTAT/ EMTRICITABINE/ TENOFOVIR ALAFENAMIDE OXYTETRACYCLIN, NYSTATIN FINGOLIMOD (HYDROCHLORIDE) 0.50 MG AFATINIB IMATINIB GLYBERA ALIPOGENE TIPARVOVEC Q.S. UNIQURE BIOPHARMA B.V GRASTOFIL FILGASTRIM ETHINYLESTRADIOL 35.00 MCG, CYPROTERONE ACETATE 2.00 MG HYDROXYETHYL STARCH HYDROXYETHYL STARCH LEDIPASVIR, SOFOSBUVIR CHLORMADINONE, ETHINYLESTRADIOL TASIMELTEON Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed) Apotex Europe PASS New AS, PASS New AS PASS New AS, Auth under excep circumstances, PASS New Biological 3DDD PHARMA N.V. PASS FRESENIUS KABI NV FRESENIUS KABI NV GILEAD SCIENCES LTD Mithra Pharmaceuticals S.A. Vanda Pharmaceuticals Limited Ltd Outcome Referral Art 31, PASS Outcome Referral Art 31, PASS New AS Outcome Referral Art 31, PASS New AS SANOFI PASTEUR SA New Biological GARDASIL 9 GAZYVARO GENVOYA GRATIELLA 35 HAES-STERIL 6% HAES-STERIL 10% HARVONI HELEN HETLIOZ HEXACIMA SANOFI PASTEUR MSD New AS ROCHE REGISTRATION LIMITED New AS GILEAD SCIENCES LTD New AS Pliva Hrvatska d.o.o. NOVARTIS EUROPHARM LIMITED Boehringer Ingelheim International NOVARTIS EUROPHARM LIMITED HEXYON Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and SANOFI PASTEUR MSD Haemophilus influenzae type B conjugate vaccine (adsorbed) New Biological HOLOCLAR EX VIVO EXPENDED AUTOLOGOUS HUMAN CORNEAL CHIESI FARMACEUTICI SPA EPITHELIAL CELLS CONTAINING STEM CELLS New AS, Cond Auth HYQVIA IMMUNOGLOBULIN HUMAN NORMAL 100.00 MG/ML BAXTER INNOVATIONS GMBH New Biological IBLIAS ICLUSIG ILARIS IMBRUVICA IMLYGIC IMNOVID (POMALIDOMIDE CELGENE) OCTOCOG ALFA PONATINIB (HYDROCHLORIDE) CANAKINUMAB IBRUTINIB TALIMOGENE LAHERPAREPVEC BAYER PHARMA AG ARIAD PHARMA LTD NOVARTIS EUROPHARM LIMITED JANSSEN-CILAG INTERNATIONAL NV AMGEN EUROPE BV New Biological New AS Auth under excep circumstances, PASS New AS New AS POMALIDOMIDE CELGENE EUROPE LIMITED New AS, PASS JANSSEN-CILAG INTERNATIONAL NV IPSEN PHARMA TAKEDA PHARMA A/S Glaxo Group Ltd HOSPIRA UK LTD New AS, Auth under excep circumstances New AS Auth under excep circumstances, PASS New AS New AS New Biological Influenza virus inactivated split virion GLAXO GROUP LTD New Biological FERRIC CARBOXYMALTOSE AXITINIB Guanfacine CANAGLIFLOZIN IVABRADINE RUXOLITINIB (PHOSPHATE) VIFOR France SA PFIZER LIMITED SHIRE PHARMACEUTICAL CONTRACTS LTD JANSSEN-CILAG INTERNATIONAL NV ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. NOVARTIS EUROPHARM LIMITED PASS New AS PASS New AS PASS New AS, PASS JARDIANCE EMPAGLIFLOZIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS JAYDESS LEVONORGESTREL 13.50 MG BAYER N.V. PASS IMVANEX INCIVO INCRELEX INCRESYNC INCRUSE INFLECTRA INFLUSPLIT/ FLUARIX TETRA INJECTAFER INLYTA INTUNIV INVOKANA IVABRADINE ANPHARM JAKAVI Modified Vaccinia Ankara virus - Bavarian Nordic (MVA-BN) live virus TELAPREVIR MECASERMIN ALOGLIPTIN/PIOGLITAZONE UMECLIDINIUM BROMIDE INFLIXIMAB BAVARIAN NORDIC A/S JENTADUETO METFORMIN HYDROCHLORIDE , LINAGLIPTIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS JETREA JINARC KADCYLA KALYDECO KANUMA KENGREXAL KETOCONAZOLE HRA KEYTRUDA KOLBAM KOVALTRY KRYSTEXXA KYPROLIS LACTEST LATUDA OCRIPLASMIN TOLVAPTAN TRASTUZUMAB EMTANSINE IVACAFTOR SEBELIPASE ALFA CANGRELOR KETOCONAZOLE PEMBROLIZUMAB CHOLIC ACID OCTOCOG ALFA PEGLOTICASE CARFILZOMIB GASILOXE LURASIDONE THROMBOGENICS NV Otsuka Pharmaceutical Europe Ltd ROCHE REGISTRATION LIMITED VERTEX PHARMACEUTICALS LIMIT Synageva BioPharma Ltd The Medicines Company UK Ltd LABORATOIRE HRA PHARMA Merck Sharp & Dohme Ltd FGK REPRESENTATIVE SERVICE GMBH BAYER PHARMA AG SAVIENT PHARMA IRELAND LIMITED AMGEN EUROPE BV Lactest S.L. / Venter Pharma S.L. TAKEDA PHARMA A/S New AS PASS New AS New AS, PASS New AS, PASS New AS PASS New AS Auth under excep circumstances New Biological New AS, PASS New AS New AS New AS LAVENTAIR LEMTRADA LENVIMA LIBERTEK LIXIANA LISVY UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE GLAXO GROUP LTD ALEMTUZUMAB LENVATINIB ROFLUMILAST ADOXABAN ETHINYLESTRADIOL, GESTODENE GENZYME THERAPEUTICS LTD EISAI EUROPE LIMITED NYCOMED GMBH DAIICHI SANKYO EUROPE GmbH GEDEON RICHTER LOJUXTA LOMITAPIDE (MESYLATE) AEGERION PHARMACEUTICALS LONQUEX LUMARK LYMPHOSEEK LYNPARZA LYXUMIA MACI MEKINIST MERIOFERT MOTILIUM MOTILIUM MOTILIUM LIPEGFILGRASTIM LUTETIUM, ISOTOPE OF MASS 177 TILMANOCEPT OLAPARIB LIXISENATIDE CHONDROCYTES, AUTOLOGOUS CULTURED Q.S. TRAMETINIB MENOTROPHIN DOMPERIDONE MALEATE DOMPERIDONE DOMPERIDONE TEVA PHARMA BV IDB RADIOPHARMACY B.V. NAVIDEA BIOPHARMACEUTICALS LIMITED LTD ASTRAZENECA AB SANOFI-AVENTIS GROUPE GENZYME EUROPE B.V. GLAXO GROUP LTD LABORATOIRE GENEVRIER SA JOHNSON & JOHNSON CONSUMER N.V. JOHNSON & JOHNSON CONSUMER N.V. PI-PHARMA NV New AS, PASS New Biological New AS PASS New AS PASS New AS, Auth under excep circumstances New AS, PASS New AS New AS New AS New AS New AS New AS New Biological PASS PASS PASS MOTILIUM MOVENTIG MYSIMBA NAGLAZYME NEURACEQ DOMPERIDONE NALOXEGOL NALTREXONE, BUPROPION GALSULFASE FLORBETABEN (18F) NEOPARIN ENOXAPARINUM NATRICUM IMPEXECO SA ASTRAZENECA AG OREXIGEN THERAPEUTICS IRELAND LIMITED BIOMARIN EUROPE LTD Piramal Imaging GmbH SciencePharma spółka z ograniczoną odpowiedzialnością spółka komandytowa PASS New AS PASS Auth under excep circumstances, PASS New AS MEDIWOUND GERMANY New AS, PASS GLAXOSMITHKLINE BIOLOGICALS S.A. New AS, PASS NOVO NORDISK A/S NOVO NORDISK A/S GLAXOSMITHKLINE TRADING SERVICES New AS New AS New AS BAXTER S.A. Outcome Referral Art 31, PASS OCTAPHARMA AB New Biological NUWIQ PROTEOLYTIC ENZYMES (CONCENTRATE) ENRICHED IN BROMELAIN NEISSERIA MENINGITIDES A+C+W+Y, POLYSACCHARIDE CONJ. TO TETANUS TOXOID Q.S. Turoctocog alfa CATRIDECACOG MEPOLIZUMAB alanine, arginine, aspartic acid, calcium chloride, cysteine, glucose monohydrate, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, magnesium acetate, methionine, olive oil, ornithine hydrochloride, henylalanine, potassium acetate, proline, serine, sodium chloride, sodium glycerophosphate, soybean oil, taurine, threonine, tryptophan, tyrosine, valine SIMOCTOCOG ALFA OBIZUR SUSOCTOCOG ALFA BAXALTA INNOVATIONS GMBH ODOMZO SONIDEGIB NOVARTIS EUROPHARM LIMITED New AS New AS, authorised under excep circumstances New AS OFEV NINTEDANIB BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS OLYSIO ONCASPAR OPDIVO OPGENRA OPSUMIT OPTIMARK ORBACTIV ORKAMBI SIMEPREVIR PEGASPERGASE NIVOLUMAB EPTOTERMIN ALFA MACITENTAN GADOVERSETAMIDE ORITAVANCIN LUMACAFTOR/ IVACAFTOR JANSSEN-CILAG INTERNATIONAL NV BAXALTA INNOVATIONS GMBH BRISTOL-MYERS SQUIBB PHARMA EEIG OLYMPUS BIOTECH LTD Actelion Registration Ltd MALLINCKRODT MEDICAL GMBH THE MEDICINES COMPANY UK LTD VERTEX PHARMACEUTICALS LIMIT New AS New biological New AS PASS New AS PASS New AS New AS NEXOBRID NIMENRIX NOVOEIGHT NOVOTHIRTEEN NUCALA NUMETZAH G16%E OROPERIDYS ORPHACOL OSSEOR OTEZLA OVALEAP PERJETA PICATO PIXUVRI PLASMAVOLUME REDIBAG 6% PLEGRIDY PORTRAZZA PRALUENT DOMPERIDONE CHOLIC ACID STRONTIUM RANELATE APREMILAST FOLLITROPIN ALPHA PERTUZUMAB INGENOL MEBUTATE PIXANTRONE (DIMALEATE) PIERRE FABRE MEDICAMENT LABORATOIRES CTRS SERVIER, LES LABORATOIRES CELGENE EUROPE LIMITED TEVA PHARMA GMBH ROCHE REGISTRATION LIMITED LEO PHARMA A/S CTI LIFE SCIENCES LTD PASS Auth under excep circumstances PASS New AS New Biological New AS New AS New AS, Cond Auth HYDROXYETHYL STARCH BAXTER S.A. Outcome Referral Art 31, PASS PEGINTERFERON BETA-1A NECITUMUMAB ALIROCUMAB BIOGEN IDEC LTD ELI LILLY NEDERLAND BV SANOFI-AVENTIS GROUPE New AS New AS New AS PRAXBIND IDARUCIZUMAB BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS PROCORALAN PROTELOS QUINSAIR RAPLIXA RAVICTI RAXONE IVABRADINE STRONTIUM RANELATE LEVOFLOXACIN HUMAN FIBRINOGEN , HUMAN THROMBIN GLYCEROL PHENYLBUTYRATE IDEBENONE SERVIER, LES LABORATOIRES PASS SERVIER, LES LABORATOIRES PASS Aptalis Pharma SAS PASS PROFIBRIX BV New Biological HORIZON THERAPEUTIC LIMITED New AS, PASS SANTHERA PHARMACEUTICALS ( Deutschland) GmbhAuth under excep circumstances RELVAR ELLIPTA FLUTICASONE FUROATE: VILANTEROL TRIFENATATE GLAXO GROUP LTD New AS, PASS REMSIMA REPATHA RESPREEZA INFLIXIMAB EVOLOCUMAB HUMAN ALFA-1 PROTEINASE INHIBITOR CELLTRION HEALTHCARE HUNGARY KFT. AMGEN EUROPE BV CSL BEHRING GmbH New Biological New AS New AS REVESTIVE TEDUGLUTIDE NYCOMED DANMARK APS New AS, PASS REVINTY ELLIPTA FLUTICASONE FUROATE/ VILANTEROL TRIFENATATE GLAXO GROUP LTD PASS REVLIMID REZOLSTA RISTEMPA RIXUBIS LENALIDOMIDE DARUNAVIR/COBICISTAT PEGFILGRASTIM NONACOG GAMMA CELGENE EUROPE LIMITED JANSSEN-CILAG INTERNATIONAL NV AMGEN EUROPE BV BAXTER INNOVATIONS GMBH PASS New AS New Biological New Biological SAXENDA INSULIN ASPART 30.00 UML, INSULIN DEGLUDEC 70.00 UML LIRAGLUTIDE SCENESSE AFAMELANOTIDE CLINUVEL UK LIMITED SEASONIQUE SEEBRI BREEZHALER SELINCRO SENSHIO SIGNIFOR SIRTURO SIVEXTRO SOMATROPIN BIOPARTNERS SOVALDI LEVONORGESTREL, ETHINYLESTRADIOL GLYCOPYRRONIUM (BROMIDE) NALMEFENE (HYDROCHLORIDE DIHYDRATE) OSPEMIFENE PASIREOTIDE (DIASPARTATE) BEDAQUILINE TEDIZOLID PHOSPHATE TEVA PHARMA BELGIUM N.V. NOVARTIS EUROPHARM LIMITED LUNDBECK A/S SHIONOGI LIMITED NOVARTIS EUROPHARM LIMITED JANSSEN-CILAG INTERNATIONAL NV CUBIST UK LTD New Biological New AS, Auth under excep circumstances PASS New AS, PASS New AS New as, PASS New AS New AS, conditional auth New AS SOMATROPIN BIOPARTNERS New Biological SOFOSBUVIR New AS AVANAFIL REGORAFENIB GILEAD SCIENCES INTERNATIONAL LTD Medac Gesellschaft für Klinische Spezialialpräparate mbh VIVUS BV BAYER AG STRENSIQ ASFOTASE ALFA ALEXION EUROPE SAS New AS, Aut under excep circumstances STRIBILD TENOFOVIR DISOPROXIL (FUMARATE) , EMTRICITABINE , ELVITEGRAVIR , COBICISTAT GILEAD SCIENCES LTD New AS STRIVERDI RESPIMAT OLODATEROL BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS, PASS SYLVANT SILTUXIMAB JANSSEN-CILAG INTERNATIONAL NV New AS SYNJARDY EMPAGLIFLOZIN/METFORMIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS TAFINLAR TAGRESSO TARGOCID TETRASPAN 6% TETRASPAN 10% THIOSIX TIVICAY TOVANOR BREEZHALER DABRAFENIB OSIMERTINIB ACIPIMOX HYDROXYETHYL STARCH HYDROXYETHYL STARCH TIOGUANIN DOLUTEGRAVIR GLYCOPYRRONIUM (BROMIDE) GLAXOSMITHKLINE TRADING SERVICES LIMITED ASTRAZENECA AB PFIZER B. BRAUN MELSUNGEN AG B. BRAUN MELSUNGEN AG TEVA NEDERLAND B.V. New AS New AS, conditional auth PASS Outcome Referral Art 31, PASS Outcome Referral Art 31, PASS Auth under excep circumstances New AS New AS, PASS RYZODEG SPECTRILA SPEDRA STIVARGA ASPARGINASE NOVO NORDISK A/S New AS NOVO NORDISK A/S ViiV Healthcare UK Limited NOVARTIS EUROPHARM LIMITED New biological New AS New AS TRAJENTA LINAGLIPTIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH New AS TRANSLARNA TRESIBA TRIUMEQ TRULICITY TYBOST TYSABRI ATALUREN INSULIN DEGLUDEC DOLUTEGRAVIR, ABACAVIR, LAMIVUDINE DULAGLUTIDE COBICISTAT NATALIZUMAB INDACATEROL (MALEATE) , GLYCOPYRRONIUM (BROMIDE) INDACATEROL (MALEATE) , GLYCOPYRRONIUM (BROMIDE) DINUTUXIMAB SODIUM VALPROATE SODIUM VALPROATE, VALPROIC ACID PTC Therapeutics Limited NOVO NORDISK A/S VIIV HEALTHCARE UK Ltd ELI LILLY NEDERLAND BV Gilead Sciences BIOGEN IDEC LTD New AS, conditional auth New AS New AS New AS New AS PASS NOVARTIS EUROPHARM LIMITED PASS NOVARTIS EUROPHARM LIMITED PASS UNITED THERAPEUTICS EUROPE LTD MYLAN BVBA EG New AS, PASS PASS PASS SODIUM VALPROATE MYLAN BVBA PASS SODIUM VALPROATE, VALPROIC ACID NINTEDANIB Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed) TOCOPHEROL D-ALPHA (AS TOCOFERSOLAN) Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches IRON SUCROSE HYDROXYETHYL STARCH INFLUENZA VIRUS (INACTIVATED) Q.S. TELAVANCIN BOCEPREVIR OMBITASVIR, PARITAPREVIR, RITONAVIR ELOSULFASE ALFA ALOGLYPTIN / METFORMIN ALOGLYPTIN ELVITEGRAVIR SANDOZ NV BOEHRINGER INGELHEIM INTERNATIONAL GMBH PASS New AS SANOFI PASTEUR MSD SNC New Biological ORPHAN EUROPE SARL Auth under excep circumstances, PASS Vifor Fresenius Medical Care Renal Pharma France New AS Vifor France B. BRAUN MELSUNGEN AG BAXTER INNOVATIONS GMBH Clinigen Healthcare Limited MERCK SHARP & DOHME LTD ABBVIE LTD BIOMARIN EUROPE LTD TAKEDA PHARMA A/S TAKEDA PHARMA A/S Gilead Sciences International Ltd PASS Outcome Referral Art 31, PASS New AS PASS New AS New AS New AS, PASS New AS New AS New AS ULTIBRO BREEZHALER ULUNAR BREEZHALER UNITUXUN VALPROATE MYLAN VALPROATE RETARD EG VALPROATE RETARD MYLAN VALPROATE SANDOZ VARGATEF VAXELIS VEDROP VELPHORO VENOFER VENOHES 6% VEPACEL VIBATIV VICTRELIS VIEKIRAX VIMIZIM VIPDOMET VIPIDIA VITEKTA VIZAMYL VOKANAMET VOLULYTE 6% VOLUVEN 6% VOLUVEN 10% FLUTEMETAMOL (18F) CANAGLIFLOZIN / METFORMIN HYDROCHLORIDE HYDROXYETHYL STARCH HYDROXYETHYL STARCH HYDROXYETHYL STARCH FACTOR VIII HUMAN 1000.00 IU, FACTOR VON WILLEBRAND 2400.00 IU GE Healthcare Ltd JANSSEN-CILAG INTERNATIONAL NV FRESENIUS KABI NV FRESENIUS KABI NV FRESENIUS KABI NV New AS New AS Outcome Referral Art 31, PASS Outcome Referral Art 31, PASS Outcome Referral Art 31, PASS TEVA PHARMA BV New Biological VYNDAQEL TAFAMIDIS (MEGLUMINE) PFIZER LIMITED WAKIX XADAGO XAGRID XALKORI XARELTO XGEVA XIGDUO XOFIGO XOTERNA BREEZHALER XTANDI XULTOPHY XYDALBA YERVOY ZALTRAP ZELBORAF ZERBAXA ZILIUM PITOLISANT HYDROCHLORIDE SAFINAMIDE XAGRID CRIZOTINIB RIVAROXABAN 10.00 MG DENOSUMAB DAPAGLIFLOZIN/METFORMIN Radium Ra 223 dichloride INDACATEROL / GLYCOPYRRONIUM ENZALUTAMIDE INSULIN DEGLUDEC, LIRAGLUTIDE DALBAVANCIN IPILIMUMAB AFLIBERCEPT VEMURAFENIB CEFTOLOZANE/ TAZOBACTAM DOMPERIDONE MALEATE CEFTAROLINE FOSAMIL (ACETIC ACID SOLVATE MONOHYDRATE) BIOPROJET PHARMA Zambon Group SpA SHIRE PHARMACEUTICAL CONTRACTS LTD PFIZER LIMITED BAYER SCHERING PHARMA AG AMGEN EUROPE BV BRISTOL MYERS SQUIBB/PFIZER EEIG Bayer Pharma AG TEVA PHARMA BV ASTELLAS PHARMA EUROPE B.V. 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PASS MERCK SHARP & DOHME LTD ASTRAZENECA AB GILEAD SCIENCES INTERNATIONAL LTD NOVARTIS EUROPHARM LIMITED JANSSEN-CILAG INTERNATIONAL NV New AS New AS, PASS New AS New AS, Cond Auth New AS VONCENTO ZINFORO ZOELY ZONTIVITY ZURAMPIC ZYDELIG ZYKADIA ZYTIGA NOMOGESTROL ACETATE / ESTRADIOL HEMIHYDRATE VORAPAXAR LESINURAD IDELALISIB CERITINIB ABIRATERONE ACETATE NOTE In Red in Black in blue in grey New AS New Biological PASS Conditional auth Auth under excep circumstances commercialised / commercialisé / gecommercialiseerd not commercialised / pas commercialisé / niet gecommercialiseerd 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 informations sursur lesles produits produits/productinformatie / produkten informaties http://www.fagg-afmps.be/search?language=fr&search_field=notice
