13 ADDITIONS - 1 RETRAIT

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1 Final Belgian list: (Last update 07/12/2015) marketing name Active substance MAH Reason on list Monthly modifications: +/- 13 ADDITIONS - 1 RETRAIT ABASRIA INSULINE GLARGINE ELI LILLY REGIONAL OPERATIONS GMBH ACCOFIL FILGASTRIM ACCORD HEALTHCARE LIMITED ADCETRIS BRENTUXIMAB VEDOTINE TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD, Cond Auth, ADEMPAS RIOCIGUAT BAYER PHARMA AKYNZEO NETUPITANT, PALONOSETRON HELSINN BIREX PHARMACEUTICALS LTD ALBUMEON HUMAN ALBUMIN? New biological ALDURAZYME LARONIDASE GENZYME EUROPE B.V. Auth under excep, AMITIZA LUBIPROSTON Sucampo Pharma Europe Ltd 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 ATRIANCE NELARABINE 5.00 MG/ML GLAXO GROUP LTD Auth under excep ATRYN ANTITHROMBIN ALFA GTC BIOTHERAPEUTICS UK LIMITED Auth under excep, 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. BLINCYTO BLINATUMOMAB AMGEN EUROPE BV, conditional auth + 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 CERDELGA ELIGLUSTAT GENZYME EUROPE B.V., CHAMPIX VARENICLINE (TARTRATE) PFIZER LIMITED CINRYZE C1-INHIBITOR IU VIROPHARMA BVBA CLAUDIA - 35 SANDOZ N.V. CLEVIPREX CLEVIDIPINE BUTYRATE THE MEDICINES COMPANY UK LTD CLUVOT HUMAN FACTOR VIII CSL BEHRING GmbH COMETRIQ CABOZANTINIB TMC Pharma Services Ltd, Cond Auth CONSTELLA LINACLOTIDE ALMIRALL S.A CONVULEX VALPROIC ACID TAKEDA BELGIUM CORLENTOR IVABRADINE SERVIER, LES LABORATOIRES COSENTYX SECUKINUMAB NOVARTIS EUROPHARM LIMITED COTELLIC COBIMETINIB ROCHE REGISTRATION LIMITED + CRESEMBA ISAVUCONAZOLE BASILEA MEDICAL LTD + 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

2 DALIRESP ROFLUMILAST MCG NYCOMED GMBH DAPHNE MITHRA PHARMACEUTICALS S.A. DAXAS ROFLUMILAST NYCOMED GMBH DEFITELIO DEFIBROTIDE Gentium New biological, authorised under exceptional 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 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 EBYMECT DAPAGLIFLOZIN/METFORMIN ASTRAZENECA AB + EDARBI AZILSARTAN MEDOXOMIL (POTASSIUM) TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD EDISTRIDE DAPAGLIFLOZIN ASTRAZENECA AB + 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 ELIQUIS APIXABAN BRISTOL MYERS SQUIBB/PFIZER EEIG ELISAMYLAN 35 MYLAN BVBA/SPRL ELOCTA EFMOROCTOCOG ALFA BIOGEN IDEC LTD + ELVANSE / TYVENSE LISDEXAMPHETAMINE BRYSTOL MYERS SQUIBB/ PFIZER EEIG ENTRESTO SACUBITRIL/ VALSARTAN NOVARTIS EUROPHARM LIMITED + ENTYVIO VEDOLIZUMAB TAKEDA PHARMA A/S 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. EVIPLERA ENOFOVIR DISOPROXIL (FUMARATE), EMTRICITABINE GILEAD SCIENCES LTD, RILPIVIRINE (HYDROCHLORIDE) EVOLTRA CLOFARABINE GENZYME EUROPE B.V. Auth under excep EVOTAZ ATAZANAVIR/COBICISTAT Bristol-Myers Squibb Pharma Eeig

3 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 FARYDAK Panobinostat Novartis Europharm limited FERTINORM KIT Gonadotrophin Postmenopausal (HMG) Non Numerical Laboratoires Amount quantum Genévrier satis SA FEXERIC FERRIC CITRATE COORDINATION COMPLEX KERYX BIOPHARMA UK LTD, FIRDAPSE AMIFAMPRIDINE (PHOSPHATE) BIOMARIN EUROPE LTD Auth under excep, 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 GENVOYA ELVITEGRAVIR/ COBICISTAT/ EMTRICITABINE/ TENOFOVIR ALAFENAMIDE GILEAD SCIENCES LTD + 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, GRASTOFIL FILGASTRIM Apotex Europe GRATIELLA 35 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, HETLIOZ TASIMELTEON Vanda Pharmaceuticals Limited Ltd 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 MG/ML BIOCLS GMBH 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 ICLUSIG PONATINIB (HYDROCHLORIDE) ARIAD PHARMA LTD

4 ILARIS CANAKINUMAB NOVARTIS EUROPHARM LIMITED Auth under excep, 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 INCIVO TELAPREVIR JANSSEN-CILAG INTERNATIONAL NV INCRELEX MECASERMIN IPSEN PHARMA Auth under excep, INCRESYNC ALOGLIPTIN/PIOGLITAZONE TAKEDA PHARMA A/S INCRUSE UMECLIDINIUM BROMIDE Glaxo Group Ltd INFLECTRA INFLIXIMAB HOSPIRA UK LTD INFLUSPLIT/ FLUARIX TETRA Influenza virus inactivated split virion GLAXO GROUP LTD Biological INLYTA AXITINIB PFIZER LIMITED INTUNIV Guanfacine SHIRE PHARMACEUTICAL CONTRACTS LTD INVOKANA CANAGLIFLOZIN JANSSEN-CILAG INTERNATIONAL NV IPREZIV AZILSARTAN MEDOXOMIL (POTASSIUM) TAKEDA GLOBAL R&D CENTRE (EUROPE) LTD IVABRADINE ANPHARM IVABRADINE ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. 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 JETREA OCRIPLASMIN THROMBOGENICS NV JEVTANA CABAZITAXEL SANOFI-AVENTIS GROUPE JINARC TOLVAPTAN Otsuka Pharmaceutical Europe Ltd KADCYLA TRASTUZUMAB EMTANSINE ROCHE REGISTRATION LIMITED KALYDECO IVACAFTOR VERTEX PHARMACEUTICALS LIMIT, KANUMA SEBELIPASE ALFA Synageva BioPharma Ltd, KENGREXAL CANGRELOR The Medicines Company UK Ltd KETOCONAZOLE HRA KETOCONAZOLE LABORATOIRE HRA PHARMA KEYTRUDA PEMBROLIZUMAB Merck Sharp & Dohme Ltd KOLBAM CHOLIC ACID FGK REPRESENTATIVE SERVICE GMBH Auth under excep KRYSTEXXA PEGLOTICASE SAVIENT PHARMA IRELAND LIMITED, KYPROLIS CARFILZOMIB AMGEN EUROPE BV + 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 LIBERTEK ROFLUMILAST NYCOMED GMBH LOJUXTA LOMITAPIDE (MESYLATE) AEGERION PHARMACEUTICALS, Auth under excep LONQUEX LIPEGFILGRASTIM TEVA PHARMA BV, LYMPHOSEEK TILMANOCEPT NAVIDEA BIOPHARMACEUTICALS LIMITED LTD LYNPARZA OLAPARIB ASTRAZENECA AB

5 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 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 MYSIMBA NALTREXONE, BUPROPION OREXIGEN THERAPEUTICS IRELAND LIMITED NAGLAZYME GALSULFASE BIOMARIN EUROPE LTD Auth under excep, NEURACEQ FLORBETABEN (18F) Piramal Imaging GmbH PROTEOLYTIC ENZYMES (CONCENTRATE) ENRICHED IN NEXOBRID MEDIWOUND GERMANY, BROMELAIN NIMENRIX NEISSERIA MENINGITIDES A+C+W+Y, POLYSACCHARIDE CONJ. TO TETANUS TOXOID Q.S. GLAXOSMITHKLINE BIOLOGICALS S.A., NIVOLUMAB BMS NIVOLUMAB BRISTOL-MYERS SQUIBB PHARMA EEIG NOVOEIGHT Turoctocog alfa NOVO NORDISK A/S NOVOTHIRTEEN CATRIDECACOG NOVO NORDISK A/S NULOJIX BELATACEPT BRISTOL-MYERS SQUIBB PHARMA EEIG 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 BAXTER S.A. hydrochloride, henylalanine, potassium acetate, proline, serine, sodium chloride, sodium glycerophosphate, soybean oil, taurine, threonine, tryptophan, tyrosine, valine Outcome Referral Art 31, NUWIQ SIMOCTOCOG ALFA OCTAPHARMA AB OBIZUR SUSOCTOCOG ALFA BAXALTA INNOVATIONS GMBH, authorised under excep ODOMZO SONIDEGIB NOVARTIS EUROPHARM LIMITED 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 ORBACTIV ORITAVANCIN THE MEDICINES COMPANY UK LTD ORKAMBI LUMACAFTOR/ IVACAFTOR VERTEX PHARMACEUTICALS LIMIT + OROPERIDYS DOMPERIDONE PIERRE FABRE MEDICAMENT ORPHACOL CHOLIC ACID LABORATOIRES CTRS Auth under excep OSSEOR STRONTIUM RANELATE SERVIER, LES LABORATOIRES OTEZLA APREMILAST CELGENE EUROPE LIMITED OVALEAP FOLLITROPIN ALPHA TEVA PHARMA GMBH PANDEMRIX INFLUENZA VIRUS (INACTIVATED) Q.S. GLAXOSMITHKLINE BIOLOGICALS S.A. PERJETA PERTUZUMAB ROCHE REGISTRATION LIMITED PICATO INGENOL MEBUTATE LEO PHARMA A/S +

6 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, PRALUENT ALIROCUMAB SANOFI-AVENTIS GROUPE PRAXBIND IDARUCIZUMAB BOEHRINGER INGELHEIM INTERNATIONAL GMBH + PROCORALAN IVABRADINE SERVIER, LES LABORATOIRES PROTELOS STRONTIUM RANELATE SERVIER, LES LABORATOIRES QUINSAIR LEVOFLOXACIN Aptalis Pharma SAS RAPLIXA HUMAN FIBRINOGEN, HUMAN THROMBIN PROFIBRIX BV RAXONE IDEBENONE SANTHERA PHARMACEUTICALS ( Deutschland) GmbhAuth under excep RELVAR ELLIPTA FLUTICASONE FUROATE: VILANTEROL TRIFENATATE GLAXO GROUP LTD, REMSIMA INFLIXIMAB CELLTRION HEALTHCARE HUNGARY KFT. REPATHA EVOLOCUMAB AMGEN EUROPE BV RESPREEZA HUMAN ALFA-1 PROTEINASE INHIBITOR CSL BEHRING GmbH REVESTIVE TEDUGLUTIDE NYCOMED DANMARK APS, REVLIMID LENALIDOMIDE CELGENE EUROPE LIMITED REVINTY ELLIPTA FLUTICASONE FUROATE: VILANTEROL TRIFENATATE GLAXO GROUP LTD REZOLSTA DARUNAVIR/COBICISTAT JANSSEN-CILAG INTERNATIONAL NV RISTEMPA PEGFILGRASTIM AMGEN EUROPE BV RIXUBIS NONACOG GAMMA BAXTER INNOVATIONS GMBH RYZODEG INSULIN ASPART UML, INSULIN DEGLUDEC UML NOVO NORDISK A/S SAXENDA LIRAGLUTIDE NOVO NORDISK A/S SCENESSE AFAMELANOTIDE CLINUVEL UK LIMITED, Auth under excep SEASONIQUE LEVONORGESTREL, ETHINYLESTRADIOL TEVA PHARMA BELGIUM N.V.? + SEEBRI BREEZHALER GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED, SELINCRO NALMEFENE (HYDROCHLORIDE DIHYDRATE) LUNDBECK A/S SENSHIO OSPEMIFENE SHIONOGI LIMITED New as, SIGNIFOR PASIREOTIDE (DIASPARTATE) NOVARTIS EUROPHARM LIMITED SIRTURO BEDAQUILINE JANSSEN-CILAG INTERNATIONAL NV, conditional auth SIVEXTRO TEDIZOLID PHOSPHATE CUBIST UK LTD SOMATROPIN BIOPARTNERS SOMATROPIN BIOPARTNERS SOVALDI SOFOSBUVIR GILEAD SCIENCES INTERNATIONAL LTD SPEDRA AVANAFIL VIVUS BV STIVARGA REGORAFENIB BAYER AG STRENSIQ ASFOTASE ALFA ALEXION EUROPE SAS, Aut under excep 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

7 TARGOCID ACIPIMOX PFIZER 0 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, THIOSIX TIOGUANIN TEVA NEDERLAND B.V. Auth under excep 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 TYGACIL TIGECYCLINE PFIZER LIMITED TYSABRI NATALIZUMAB BIOGEN IDEC LTD ULTIBRO BREEZHALER INDACATEROL (MALEATE), GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED ULUNAR BREEZHALER INDACATEROL (MALEATE), GLYCOPYRRONIUM (BROMIDE) NOVARTIS EUROPHARM LIMITED UNITUXUN DINUTUXIMAB UNITED THERAPEUTICS EUROPE LTD, 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 VEDROP TOCOPHEROL D-ALPHA (AS TOCOFERSOLAN) ORPHAN EUROPE SARL Auth under excep, VELPHORO Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose Vifor Fresenius Medical Care Renal Pharma France and starches VENOFER IRON SUCROSE Vifor France 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 VOTUBIA EVEROLIMUS NOVARTIS EUROPHARM LIMITED Conditional auth -

8 VYNDAQEL TAFAMIDIS (MEGLUMINE) PFIZER LIMITED Auth under excep, New AS, XADAGO SAFINAMIDE Zambon Group SpA XAGRID XAGRID SHIRE PHARMACEUTICAL CONTRACTS LTD Auth under excep XALKORI CRIZOTINIB PFIZER LIMITED, Cond Auth XARELTO RIVAROXABAN 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/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 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 ZALTRAP AFLIBERCEPT SANOFI-AVENTIS GROUPE ZELBORAF VEMURAFENIB ROCHE REGISTRATION LIMITED ZERBAXA CEFTOLOZANE/ TAZOBACTAM MERCK SHARP & DOHME LTD 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 ZYKADIA CERITINIB NOVARTIS EUROPHARM LIMITED, Cond Auth ZYTIGA ABIRATERONE ACETATE JANSSEN-CILAG INTERNATIONAL NV NOTE In Red in Black in blue in grey Conditional auth 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

9 Auth under excep autorisé sous circonstances exceptionnelles / vergund onder uitzonderlijke omstandigheden Product informations / informations sur les produits / produkten informaties informations sur les produits/productinformatie