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EMA-Approved Drugs Directory

European Medicines Agency approved medicines with EPAR-derived status, INN profiles, and competitive intelligence links.

Quick answer

EMA-approved drugs: NovaPharmaNews tracks 931 pharmaceutical drugs in this segment. European Medicines Agency approved medicines with EPAR-derived status, INN profiles, and competitive intelligence links.

931 drugs · EMA approved · by data quality · Page 7 of 39

  1. memantine hydrochloride

    MEMANTINE MERZ Amneal Pharma Europe Ltd

    ORAL FDA: approved · EMA: approved · PMDA: approved

    N06DX01

  2. meropenem

    VABOREM Amneal Pharma Europe Ltd

    INJECTION FDA: approved · EMA: approved · NMPA: clinical trials

    J01DH

  3. methylphenidate hydrochloride

    TUZULBY Amneal Pharma Europe Ltd

    ORAL FDA: approved · EMA: approved

    N06BA04

  4. midostaurin

    RYDAPT Novartis Pharmaceuticals

    ORAL FDA: approved · EMA: approved · TGA: approved

    L01XE

  5. mifamurtide

    MEPACT S.A.

    EMA: approved

    L03AX15

  6. mirabegron

    BETMIGA Sunshine Guojian Pharmaceutical (Shanghai) Co.,

    ORAL FDA: approved · EMA: approved · PMDA: approved · NMPA: clinical trials

    G04BD12

  7. mitapivat

    PYRUKYND Agios Netherlands B.V.

    EMA: approved

    B06AX04

  8. mitotane

    LYSODREN S.A.

    ORAL FDA: approved · EMA: approved

    L01XX23

  9. mycophenolate mofetil

    CELLCEPT Teva Pharma GmbH

    ORAL FDA: approved · EMA: approved

    L04AA06

  10. naltrexone

    ARX-NALTREXONE Lacuna Pharma Pty Ltd

    INTRAMUSCULAR FDA: approved · EMA: approved · TGA: approved

    A08AA

  11. nelarabine

    ATRIANCE Amneal Pharma Europe Ltd

    INTRAVENOUS FDA: approved · EMA: approved

    L01BB07

  12. nevirapine

    NEVIRAPINE VIATRIS Alphapharm Pty Ltd

    ORAL FDA: approved · EMA: approved · TGA: approved

    J05AG01

  13. nintedanib

    OFEV Boehringer Ingelheim Pty Ltd

    ORAL FDA: approved · EMA: approved · TGA: approved · NMPA: clinical trials

    L01EX09

  14. nitisinone

    NITYR Eton Pharmaceuticals

    ORAL FDA: approved · EMA: approved · PMDA: approved

    A16AX04

  15. obecabtagene autoleucel

    AUCATZYL Autolus GmbH

    EMA: approved

    L01XL

  16. octocog alfa

    ADVATE Takeda

    EMA: approved

    B02BD02

  17. odronextamab

    ORDSPONO Regeneron UK Limited

    EMA: approved

    Not yet assigned

  18. olanzapine

    APO-OLANZAPINE ODT Alphapharm Pty Ltd

    INTRAMUSCULAR FDA: approved · EMA: approved · TGA: approved · PMDA: approved · NMPA: clinical trials

    N05AH03

  19. opicapone

    ONGENTYS Lacuna Pharma Pty Ltd

    ORAL FDA: approved · EMA: approved · TGA: approved · PMDA: approved

    N04

  20. oxybutynin

    DITROPAN Sanofi-aventis Healthcare Pty Ltd

    TRANSDERMAL FDA: approved · EMA: approved · TGA: approved

    G04BD04

  21. paclitaxel

    PACLITAXEL ACCORD Accord Healthcare Pty.

    INJECTION FDA: approved · EMA: approved · TGA: approved · PMDA: approved · NMPA: clinical trials

    L01CD01

  22. paliperidone

    INVEGA Janssen-Cilag Pty Ltd

    ORAL FDA: approved · EMA: approved · TGA: approved

    N05AX13

  23. paltusotine

    PALSONIFY Crinetics Pharmaceuticals Europe GmbH

    EMA: approved

    H01CB06

  24. pantoprazole

    APO-PANTOPRAZOLE Alphapharm Pty Ltd

    EMA: approved · TGA: approved

    A02BC02

Frequently asked questions

How many ema approved drugs are listed?

931 drug profiles match this regulatory segment in our published index.

Where does approval data come from?

Profiles combine FDA Drugs@FDA, EMA EPAR references, and regional authority feeds. See our data sources page for attribution.

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