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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 2 of 39

  1. bexarotene

    TARGRETIN Amneal Pharma Europe Ltd

    TOPICAL FDA: approved · EMA: approved

    L01XF03

  2. bimatoprost

    BIMATOPROST SANDOZ Alphapharm Pty Ltd

    OPHTHALMIC FDA: approved · EMA: approved · TGA: approved

    S01EE03

  3. binimetinib

    MEKTOVI Pierre Fabre Australia Pty Ltd

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

    L01EE03

  4. bortezomib

    BORTEZOM Pfizer Australia Pty Ltd

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

    L01XG01

  5. bosentan

    BOSENTAN APO Alphapharm Pty Ltd

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

    C02KX01

  6. brentuximab vedotin

    ADCETRIS Lacuna Pharma Pty Ltd

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

    L01FX05

  7. brexpiprazole

    REXULTI Amneal Pharma Europe Ltd

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

    N05AX16

  8. brigatinib

    ALUNBRIG Lacuna Pharma Pty Ltd

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

    L01XE43

  9. brivaracetam

    BRIVIACT Sunshine Guojian Pharmaceutical (Shanghai) Co.,

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

    N03AX23

  10. budesonide

    BUDENOFALK AstraZeneca

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

    A07EA06

  11. bupivacaine

    EXPAREL LIPOSOMAL Pacira Ireland Limited

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

    N01BB01

  12. buprenorphine

    B-PATCH Indivior Pty Ltd

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

    N07BC51

  13. busulfan

    MYLERAN Lacuna Pharma Pty Ltd

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

    L01AB01

  14. c1 inhibitor (human)

    CINRYZE Takeda

    EMA: approved

    B06AC01

  15. cabazitaxel

    CABAZITAXEL ACCORD Lacuna Pharma Pty Ltd

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

    L01CD04

  16. cabozantinib

    CABOMETYX Ipsen

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

    L01XE

  17. caffeine citrate

    BLECTIFOR Viridian Pharma Ltd

    ORAL FDA: approved · EMA: approved

    N06BC01

  18. canagliflozin

    INVOKANA Teva Pharma GmbH

    ORAL FDA: approved · EMA: approved

    A10BK02

  19. cannabidiol

    EPIDYOLEX Lacuna Pharma Pty Ltd

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

    N03AX

  20. capecitabine

    CAPECITABINE SANDOZ Alphapharm Pty Ltd

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

    L01BC06

  21. carfilzomib

    KYPROLIS Amgen

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

    L01XX45

  22. carmustine

    GLIADEL Eisai Co.,

    INTRACRANIAL FDA: approved · EMA: approved · TGA: approved

    L01AD01

  23. cemiplimab

    LIBTAYO Lacuna Pharma Pty Ltd

    EMA: approved · TGA: approved · PMDA: approved

    L01XC33

  24. cerliponase alfa

    BRINEURA BioMarin Pharmaceutical Australia Pty Ltd

    INJECTION FDA: approved · EMA: approved

    A16AB

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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