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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 16 of 39

  1. ganaxolone

    ZTALMY

    ORAL FDA: approved · EMA: approved

    N03AX

  2. gefitinib

    CIPLA GEFITINIB Cipla Australia Pty Ltd

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

    L01XE02

  3. gemtuzumab ozogamicin

    MYLOTARG Pfizer Australia Pty Ltd

    SINGLE-DOSE FDA: approved · EMA: approved · TGA: approved

    L01XC05

  4. glecaprevir

    MAVIRET

    ORAL FDA: approved · EMA: approved

    J05AP57

  5. glucarpidase

    VORAXAZE

    INJECTION FDA: approved · EMA: approved

    V03AF09

  6. golimumab

    SIMPONI Janssen-Cilag Pty Ltd

    INJECTION FDA: approved · EMA: approved · TGA: approved

    L04AB06

  7. guselkumab

    TREMFYA Janssen-Cilag Pty Ltd

    INJECTION FDA: approved · EMA: approved · TGA: approved · PMDA: approved

    L04AC

  8. hydroxocobalamin

    COBAL-B12 Pfizer Australia Pty Ltd

    INJECTION FDA: approved · EMA: approved · TGA: approved

    V03AB33

  9. idarucizumab

    PRAXBIND

    INJECTION FDA: approved · EMA: approved · PMDA: approved

    V03AB

  10. idelalisib

    ZYDELIG Gilead Sciences Pty Limited

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

    L01XX47

  11. iloprost

    VENTAVIS Bayer Australia Ltd

    INHALATION FDA: approved · EMA: approved · TGA: approved

    B01AC11

  12. imiglucerase

    CEREZYME

    INJECTION FDA: approved · EMA: approved

    A16AB02

  13. inavolisib

    ITOVEBI

    ORAL FDA: approved · EMA: approved

  14. insulin aspart

    FIASP PENFILL NovoThirteen

    SUBCUTANEOUS FDA: approved · EMA: approved · TGA: approved

    A10AB05

  15. insulin degludec

    RYZODEG

    SUBCUTANEOUS FDA: approved · EMA: approved · PMDA: approved

    A10AE06

  16. insulin detemir

    LEVEMIR FLEXPEN NovoThirteen

    INJECTION FDA: approved · EMA: approved · TGA: approved

    A10AE05

  17. insulin glargine

    OPTISULIN Sanofi-aventis Healthcare Pty Ltd

    INJECTION FDA: approved · EMA: approved · TGA: approved

    A10AE04

  18. insulin human

    COMBIMARV

    SUBCUTANEOUS FDA: approved · EMA: approved

    A10AB01;A10AC01

  19. insulin icodec

    AWIQLI

    SOLUTION FDA: approved · EMA: approved · PMDA: approved

    A10AE57

  20. insulin lispro

    HUMALOG

    SUBCUTANEOUS FDA: approved · EMA: approved · TGA: approved

    A10AB04

  21. interferon beta-1b

    BETAFERON Bayer Australia Ltd

    SUBCUTANEOUS FDA: approved · EMA: approved · TGA: approved

    L03AB08

  22. ipilimumab

    YERVOY Bristol-Myers Squibb Australia Pty Ltd

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

    L01FX04

  23. ivabradine

    APO-IVABRADINE Servier Laboratories (Aust.) Pty.

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

    C01EB17

  24. ixekizumab

    TALTZ

    INJECTION FDA: approved · EMA: approved · TGA: approved · PMDA: approved

    L04AC13

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.

Drug approvals, clinical trials, M&A, event intelligence, and company updates — weekly.

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