NEISSERIA MENINGITIDES B, RECOMBINANT, COMPONENT, ADSORBED Q.S.

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1 Final Belgian list: (Last update 13/03/2015) marketing name Active substance MAH Reason on list ABASRIA INSULINE GLARGINE ELI LILLY REGIONAL OPERATIONS GMBH New Biological ACCOFIL FILGASTRIM ACCORD HEALTHCARE LIMITED New Biological ADCETRIS BRENTUXIMAB VEDOTINE TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD, Cond Auth, ADEMPAS RIOCIGUAT BAYER PHARMA ALDURAZYME LARONIDASE GENZYME EUROPE B.V. Auth under excep circumstances, AMYVID FORBETAPIR (F-18) Q.S. ELI LILLY NEDERLAND BV ANORO GLAXO GROUP LTD UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE, APLEEK ETHINYL ESTRADIOL/GESTODENE BAYER PHARMA AG ARZERRA OFATUMUMAB 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 BELLINA CHLORMADINONE, ETHINYLESTRADIOL GEDEON RICHTER Plc Outcome Referral Art 31, BEMFOLA Follitropin alfa FINOX Biotech AG New biological 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) MG PFIZER LIMITED, Cond Auth, BRETARIS GENUAIR ACLIDINIUM BROMIDE ALMIRALL S.A, BRIMICA GENUAIR ACLIDINIUM BROMIDE/ FORMOTERL FUMARATE DIHYDRATE ALMIRALL S.A, BRINTELLIX VORTIOXETINE H. LUNDBECK A/S CAPRELSA VANDETANIB ASTRAZENECA AB, Cond Auth CEPLENE HISTAMINE DIHYDROCHLORIDE MEDA AB Auth under excep circumstances CERDELGA ELIGLUSTAT GENZYME EUROPE B.V., CHAMPIX VARENICLINE (TARTRATE) PFIZER LIMITED CINRYZE C1-INHIBITOR IU VIROPHARMA BVBA CLAUDIA - 35 ETHINYLESTRADIOL MCG, CYPROTERONE ACETATE 2.00 MG SANDOZ N.V. CLEVIPREX CLEVIDIPINE BUTYRATE THE MEDICINES COMPANY UK LTD COMETRIQ CABOZANTINIB TMC Pharma Services Ltd, Cond Auth CONSTELLA LINACLOTIDE ALMIRALL S.A CONVULEX VALPROIC ACID TAKEDA BELGIUM CORLENTOR IVABRADINE SERVIER, LES LABORATOIRES

2 COSENTYX SECUKINUMAB NOVARTIS EUROPHARM LIMITED CUPRYMINA COPPER (64-CU) CHLORIDE Q.S. SPARKLE S.R.L CYRAMZA RAMUCIRUMAB ELI LILLY NEDERLAND BV DACOGEN DECITABINE JANSSEN-CILAG INTERNATIONAL NV DAKLINZA DACLATASVIR BRISTOL MYERS SQUIBB/PFIZER EEIG DALIRESP ROFLUMILAST MCG NYCOMED GMBH DAPHNE ETHINYLESTRADIOL MCG, CYPROTERONE ACETATE 2.00 MG MITHRA PHARMACEUTICALS S.A. DAXAS ROFLUMILAST NYCOMED GMBH DEFITELIO DEFIBROTIDE Gentium New biological, authorised under exceptional circumstances DELTYBA DELAMANID Otsuka Novel Products GmbH, Cond Auth DEPAKINE SODIUM VALPROATE SANOFI BELGIUM DEPAKINE CHRONO SODIUM VALPROATE, VALPROIC ACID SANOFI BELGIUM DEPAKINE CHRONO SODIUM VALPROATE, VALPROIC ACID PI-PHARMA NV DEPAKINE ENTERIC SODIUM VALPROATE SANOFI BELGIUM DEPAKINE IV SODIUM VALPROATE SANOFI BELGIUM DIANE-35 ETHINYLESTRADIOL MCG, CYPROTERONE ACETATE 2.00 MG BAYER N.V. DIFICLIR FIDAXOMICIN ASTELLAS PHARMA EUROPE B.V. DOMPERIDON MYLAN DOMPERIDONE MALEATE MYLAN SPRL DOMPERIDON TEVA DOMPERIDONE MALEATE TEVA PHARMA BELGIUM N.V. DOMPERIDONE EG DOMPERIDONE MALEATE EUROGENERICS N.V. DOMPERIDONE INSTANT DOMPERIDONE EG EUROGENERICS N.V. DOMPERIDONE MYLAN DOMPERIDONE MALEATE MYLAN BVBA/SPRL DOMPERITOP DOMPERIDONE MALEATE APOTEX NV DUAKLIR GENUAIR ACLIDINIUM BROMIDE/ FORMOTERL FUMARATE DIHYDRATE ALMIRALL S.A 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 ETHINYLESTRADIOL MCG, CYPROTERONE ACETATE 2.00 MG MYLAN BVBA/SPRL ELVANSE / TYVENSE LISDEXAMPHETAMINE BRYSTOL MYERS SQUIBB/ PFIZER EEIG ENTYVIO VEDOLIZUMAB TAKEDA PHARMA A/S

3 ENUREV BREEZHALER GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED, EPERZAN ALBIGLUTIDE GlaxoSmithKline Trading Services 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. New Biological EVIPLERA ENOFOVIR DISOPROXIL (FUMARATE), EMTRICITABINE GILEAD SCIENCES LTD, RILPIVIRINE (HYDROCHLORIDE) EVOLTRA CLOFARABINE GENZYME EUROPE B.V. Auth under excep circumstances EXJADE DEFERASIROX NOVARTIS EUROPHARM LIMITED EXVIERA DASABUVIR ABBVIE LTD EYLEA AFLIBERCEPT BAYER AG EZICLEN SULPHATE ANHYDROUS, MAGNESIUM SULFATE HEPTAHYDRATE, POTASSIUM SULPHATE IPSEN PHARMA 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 GAZYVARO OBINUTUZUMAB ROCHE REGISTRATION LIMITED GEONISTIN OXYTETRACYCLIN, NYSTATIN Pliva Hrvatska d.o.o. GILENYA FINGOLIMOD (HYDROCHLORIDE) 0.50 MG NOVARTIS EUROPHARM LIMITED, GIOTRIF AFATINIB Boehringer Ingelheim International GLIVEC IMATINIB NOVARTIS EUROPHARM LIMITED GLYBERA ALIPOGENE TIPARVOVEC Q.S. UNIQURE BIOPHARMA B.V, Auth under excep circumstances, GRASTOFIL FILGASTRIM Apotex Europe New Biological GRATIELLA 35 ETHINYLESTRADIOL MCG, CYPROTERONE ACETATE 2.00 MG 3DDD PHARMA N.V. HAES-STERIL 6% HYDROXYETHYL STARCH FRESENIUS KABI NV Outcome Referral Art 31, HAES-STERIL 10% HYDROXYETHYL STARCH FRESENIUS KABI NV Outcome Referral Art 31, HALAVEN ERIBULIN (MESYLATE) 0.44 MG/ML EISAI LIMITED HARVONI LEDIPASVIR, SOFOSBUVIR GILEAD SCIENCES LTD HELEN CHLORMADINONE, ETHINYLESTRADIOL Mithra Pharmaceuticals S.A. Outcome Referral Art 31,

4 HEXACIMA HEXYON Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rdna), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed) Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rdna), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed) SANOFI PASTEUR SA SANOFI PASTEUR MSD New Biological New Biological HIZENTRA IMMUNOGLOBULIN HUMAN NORMAL MG/ML BIOCLS GMBH New Biological HOLOCLAR EX VIVO EXPENDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS CHIESI FARMACEUTICI SPA, Cond Auth HYQVIA IMMUNOGLOBULIN HUMAN NORMAL MG/ML BAXTER INNOVATIONS GMBH New Biological ICLUSIG PONATINIB (HYDROCHLORIDE) ARIAD PHARMA LTD ILARIS CANAKINUMAB NOVARTIS EUROPHARM LIMITED Auth under excep circumstances, IMBRUVICA IBRUTINIB JANSSEN-CILAG INTERNATIONAL NV IMNOVID (POMALIDOMIDE POMALIDOMIDE CELGENE EUROPE LIMITED, CELGENE) IMVANEX Modified Vaccinia Ankara virus - Bavarian Nordic, Auth under excep BAVARIAN NORDIC A/S (MVA-BN) live virus circumstances INCIVO TELAPREVIR JANSSEN-CILAG INTERNATIONAL NV INCRELEX MECASERMIN IPSEN PHARMA Auth under excep circumstances, INCRESYNC ALOGLIPTIN/PIOGLITAZONE TAKEDA PHARMA A/S INCRUSE UMECLIDINIUM BROMIDE Glaxo Group Ltd INFLECTRA NFLIXIMAB HOSPIRA UK LTD New Biological INFLUSPLIT/ FLUARIX TETRA Influenza virus inactivated split virion GLAXO GROUP LTD Biological INLYTA AXITINIB PFIZER LIMITED INVOKANA CANAGLIFLOZIN JANSSEN-CILAG INTERNATIONAL NV IPREZIV AZILSARTAN MEDOXOMIL (POTASSIUM) TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD JAKAVI RUXOLITINIB (PHOSPHATE) NOVARTIS EUROPHARM LIMITED, JARDIANCE EMPAGLIFLOZIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH JAYDESS LEVONORGESTREL MG BAYER N.V. JENTADUETO METFORMIN HYDROCHLORIDE, LINAGLIPTIN BOEHRINGER INGELHEIM INTERNATIONAL GMBH

5 JETREA OCRIPLASMIN THROMBOGENICS NV JEVTANA CABAZITAXEL SANOFI-AVENTIS GROUPE KADCYLA TRASTUZUMAB EMTANSINE ROCHE REGISTRATION LIMITED KALYDECO IVACAFTOR VERTEX PHARMACEUTICALS LIMIT, KETOCONAZOLE HRA KETOCONAZOLE LABORATOIRE HRA PHARMA KOLBAM (previously CHOLIC ACID FGK) CHOLIC ACID FGK Representative Service GmbH Auth under excep circumstances KRYSTEXXA PEGLOTICASE SAVIENT PHARMA IRELAND LIMITED, LACTEST GASILOXE Lactest S.L. / Venter Pharma S.L. LATUDA LURASIDONE TAKEDA PHARMA A/S LAVENTAIR UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE GLAXO GROUP LTD, LEMTRADA ALEMTUZUMAB GENZYME THERAPEUTICS LTD New Biological LIBERTEK ROFLUMILAST NYCOMED GMBH LOJUXTA LOMITAPIDE (MESYLATE) AEGERION PHARMACEUTICALS, Auth under excep circumstances LONQUEX LIPEGFILGRASTIM TEVA PHARMA BV, LYMPHOSEEK TILMANOCEPT NAVIDEA BIOPHARMACEUTICALS LIMITED LTD LYNPARZA OLAPARIB ASTRAZENECA AB LYXUMIA LIXISENATIDE SANOFI-AVENTIS GROUPE MACI CHONDROCYTES, AUTOLOGOUS CULTURED Q.S. GENZYME EUROPE B.V. MEKINIST TRAMETINIB GLAXO GROUP LTD MERIOFERT MENOTROPHIN LABORATOIRE GENEVRIER SA New Biological MOTILIUM DOMPERIDONE MALEATE JOHNSON & JOHNSON CONSUMER N.V. MOTILIUM DOMPERIDONE JOHNSON & JOHNSON CONSUMER N.V. MOTILIUM DOMPERIDONE PI-PHARMA NV MOTILIUM DOMPERIDONE IMPEXECO SA MOVENTIG NALOXEGOL ASTRAZENECA AG NAGLAZYME GALSULFASE BIOMARIN EUROPE LTD Auth under excep circumstances, NEURACEQ FLORBETABEN (18F) Piramal Imaging GmbH NEXOBRID PROTEOLYTIC ENZYMES (CONCENTRATE) ENRICHED IN MEDIWOUND GERMANY BROMELAIN, 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

6 NUMETZAH G16%E 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, BAXTER S.A. Outcome Referral Art 31, proline, serine, sodium chloride, sodium glycerophosphate, soybean oil, taurine, threonine, tryptophan, tyrosine, valine NUWIQ SIMOCTOCOG ALFA OCTAPHARMA AB OFEV NINTEDANIB BOEHRINGER INGELHEIM INTERNATIONAL GMBH OLYSIO SIMEPREVIR JANSSEN-CILAG INTERNATIONAL NV OPGENRA EPTOTERMIN ALFA OLYMPUS BIOTECH LTD OPSUMIT MACITENTAN Actelion Registration Ltd OPTIMARK GADOVERSETAMIDE MALLINCKRODT MEDICAL GMBH OROPERIDYS DOMPERIDONE PIERRE FABRE MEDICAMENT ORPHACOL CHOLIC ACID LABORATOIRES CTRS Auth under excep circumstances OSSEOR STRONTIUM RANELATE SERVIER, LES LABORATOIRES OTEZLA APREMILAST CELGENE EUROPE LIMITED OVALEAP FOLLITROPIN ALPHA TEVA PHARMA GMBH New Biological 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 PLASMAVOLUME REDIBAG 6% HYDROXYETHYL STARCH BAXTER S.A. Outcome Referral Art 31, PLEGRIDY PEGINTERFERON BETA-1A BIOGEN IDEC LTD PLETAL CILOSTAZOL??? Outcome Referral Art 31, PROCORALAN IVABRADINE SERVIER, LES LABORATOIRES 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. New Biological REPLAGAL AGALSIDASE ALFA SHIRE HUMAN GENETIC THERAPIES AB Auth under excep circumstances, REVESTIVE TEDUGLUTIDE NYCOMED DANMARK APS,

7 REVLIMID LENALIDOMIDE CELGENE EUROPE LIMITED REVINTY ELLIPTA FLUTICASONE FUROATE: VILANTEROL TRIFENATATE GLAXO GROUP LTD RIENSO FERUMOXYTOL TAKEDA PHARMA A/S RIXUBIS NONACOG GAMMA BAXTER INNOVATIONS GMBH New Biological RYZODEG INSULIN ASPART UML, INSULIN DEGLUDEC UML NOVO NORDISK A/S SCENESSE AFAMELANOTIDE CLINUVEL UK LIMITED, Auth under excep circumstances SEEBRI BREEZHALER GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED, SELINCRO NALMEFENE (HYDROCHLORIDE DIHYDRATE) LUNDBECK A/S SENCHIO OSPEMIFENE SHIONOGI LIMITED New as, SIGNIFOR PASIREOTIDE (DIASPARTATE) NOVARTIS EUROPHARM LIMITED SIRTURO BEDAQUILINE JANSSEN-CILAG INTERNATIONAL NV, conditional auth SOMATROPIN BIOPARTNERS SOMATROPIN BIOPARTNERS New Biological SOVALDI SOFOSBUVIR GILEAD SCIENCES INTERNATIONAL LTD SPEDRA AVANAFIL VIVUS BV STIVARGA REGORAFENIB BAYER AG STRIBILD TENOFOVIR DISOPROXIL (FUMARATE), EMTRICITABINE, ELVITEGRAVIR, COBICISTAT GILEAD SCIENCES LTD STRIVERDI RESPIMAT OLODATEROL BOEHRINGER INGELHEIM INTERNATIONAL GMBH, SYLVANT SILTUXIMAB JANSSEN-CILAG INTERNATIONAL NV TAFINLAR DABRAFENIB GLAXOSMITHKLINE TRADING SERVICES LIMITED TARGOCID ACIPIMOX PFIZER TETRASPAN 6% HYDROXYETHYL STARCH B. BRAUN MELSUNGEN AG Outcome Referral Art 31, TETRASPAN 10% HYDROXYETHYL STARCH B. BRAUN MELSUNGEN AG Outcome Referral Art 31, 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 TRANSLARNA ATALUREN PTC Therapeutics Limited, conditional auth TRESIBA INSULIN DEGLUDEC NOVO NORDISK A/S TRIUMEQ DOLUTEGRAVIR, ABACAVIR, LAMIVUDINE VIIV HEALTHCARE UK Ltd TROBALT RETIGABINE GLAXO GROUP LTD TYBOST COBICISTAT Gilead Sciences

8 TYGACIL TIGECYCLINE PFIZER LIMITED TYSABRI NATALIZUMAB BIOGEN IDEC LTD TYVERB LAPATINIB (DITOSYLATE MONOHYDRATE) GLAXO GROUP LTD Conditional auth ULTIBRO BREEZHALER INDACATEROL (MALEATE), GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED ULUNAR BREEZHALER INDACATEROL (MALEATE), GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED VALPROATE MYLAN SODIUM VALPROATE MYLAN BVBA VALPROATE RETARD EG SODIUM VALPROATE, VALPROIC ACID EG VALPROATE RETARD MYLAN SODIUM VALPROATE MYLAN BVBA VALPROATE SANDOZ SODIUM VALPROATE, VALPROIC ACID SANDOZ NV VECTIBIX PANITUMUMAB MG/ML AMGEN EUROPE BV Conditional auth VEDROP TOCOPHEROL D-ALPHA (AS TOCOFERSOLAN) ORPHAN EUROPE SARL Auth under excep circumstances, VELPHORO Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose Vifor Fresenius Medical Care Renal Pharma France and starches VENOHES 6% HYDROXYETHYL STARCH B. BRAUN MELSUNGEN AG Outcome Referral Art 31, VEPACEL INFLUENZA VIRUS (INACTIVATED) Q.S. BAXTER INNOVATIONS GMBH VIBATIV TELAVANCIN Clinigen Healthcare Limited VICTRELIS BOCEPREVIR MERCK SHARP & DOHME LTD VIEKIRAX OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE LTD VIMIZIM ELOSULFASE ALFA BIOMARIN EUROPE LTD, VIPDOMET ALOGLYPTIN / METFORMIN TAKEDA PHARMA A/S VIPIDIA ALOGLYPTIN TAKEDA PHARMA A/S VITEKTA ELVITEGRAVIR Gilead Sciences International Ltd VIZAMYL FLUTEMETAMOL (18F) GE Healthcare Ltd VOKANAMET CANAGLIFLOZIN / METFORMIN HYDROCHLORIDE JANSSEN-CILAG INTERNATIONAL NV VOLULYTE 6% HYDROXYETHYL STARCH FRESENIUS KABI NV Outcome Referral Art 31, VOLUVEN 6% HYDROXYETHYL STARCH FRESENIUS KABI NV Outcome Referral Art 31, VOLUVEN 10% HYDROXYETHYL STARCH FRESENIUS KABI NV Outcome Referral Art 31, VONCENTO FACTOR VIII HUMAN IU, FACTOR VON WILLEBRAND IU TEVA PHARMA BV New Biological VOTUBIA EVEROLIMUS NOVARTIS EUROPHARM LIMITED Conditional auth VYNDAQEL TAFAMIDIS (MEGLUMINE) PFIZER LIMITED Auth under excep circumstances, New AS, XADAGO SAFINAMIDE ZAMBON SPA XAGRID XAGRID SHIRE PHARMACEUTICAL CONTRACTS LTD Auth under excep circumstances XALKORI CRIZOTINIB PFIZER LIMITED, Cond Auth XARELTO RIVAROXABAN MG BAYER SCHERING PHARMA AG

9 XGEVA DENOSUMAB AMGEN EUROPE BV New biological XIAPEX COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM UK LIMITED XIGDUO DAPAGLIFLOZIN/METFORMIN BRISTOL MYERS SQUIBB/PFIZER EEIG XOFIGO Radium Ra 223 dichloride Bayer Pharma AG XOTERNA BREEZHALER INDACATEROL / GLYCOPYRRONIUM TEVA PHARMA BV XTANDI ENZALUTAMIDE ASTELLAS PHARMA EUROPE B.V. XULTOPHY INSULIN DEGLUDEC, LIRAGLUTIDE NOVO NORDISK A/S New Biological XYDALBA DALBAVANCIN DURATA THERAPEUTICS INTERNATIONAL bv 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 ZILIUM DOMPERIDONE MALEATE KELA PHARMA NV ZINFORO CEFTAROLINE FOSAMIL (ACETIC ACID SOLVATE MONOHYDRATE) ASTRAZENECA AB ZOELY THERAMEX S.r.l. NOMOGESTROL ACETATE / ESTRADIOL HEMIHYDRATE ZONTIVITY VORAPAXAR MERCK SHARP & DOHME LTD ZYDELIG IDELALISIB GILEAD SCIENCES INTERNATIONAL LTD ZYTIGA ABIRATERONE ACETATE JANSSEN-CILAG INTERNATIONAL NV NOTE In Red in Black in blue in grey New Biological 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

10 Conditional auth Auth under excep circumstances 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