Intelligence Β· Drug directory

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 Β· EMA approved Β· by data quality Β· Page 9 of 39

  1. riociguat

    ADEMPAS Bayer Australia Ltd

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

    C02KX05
  2. risperidone

    APO-RISPERIDONE Servier Laboratories (Aust.) Pty.

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

    N05AX08
  3. ritonavir

    NORVIR AbbVie

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

    J05AE03
  4. rivaroxaban

    APO-RIVAROXABAN Alphapharm Pty Ltd

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

    B01AF01
  5. rivastigmine

    EXELON Novartis Pharmaceuticals

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

    N06DA03
  6. roflumilast

    DAXAS Arcutis Biotherapeutics

    TOPICAL FDA: approved Β· EMA: approved

    R03DX07
  7. salmeterol

    SEFFALAIR SPIROMAX Teva Pharma GmbH

    EMA: approved

    R03AK06
  8. sapropterin

    KUVAN BioMarin Pharmaceutical Australia Pty Ltd

    EMA: approved Β· TGA: approved

    A16AX07
  9. saxagliptin

    ONGLYZA AstraZeneca

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

    A10BD21
  10. sebetralstat

    EKTERLY Kalvista Pharmaceuticals (Ireland) Limited

    ORAL FDA: approved Β· EMA: approved

    B06AC08
  11. selinexor

    XPOVIO Shanghai Antengene Corporation Limited

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

    L01XX66
  12. sepiapterin

    SEPHIENCE PTC THERAPEUTICS, INC.

    ORAL FDA: approved Β· EMA: approved

    A16AX28
  13. setmelanotide

    IMCIVREE Rhythm Pharmaceuticals Netherlands B.V.

    EMA: approved

    A08AA
  14. sevelamer carbonate

    RENVELA Amneal Pharma Europe Ltd

    ORAL FDA: approved Β· EMA: approved

    V03AE02
  15. sildenafil

    NOUMED SILDENAFIL Alphapharm Pty Ltd

    EMA: approved Β· TGA: approved

    G04BE03
  16. silodosin

    UROREC Lacuna Pharma Pty Ltd

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

    G04CA04
  17. sirolimus

    RAPAMUNE Pfizer Australia Pty Ltd

    TOPICAL FDA: approved Β· EMA: approved Β· TGA: approved Β· PMDA: approved

    L04AH01
  18. sodium oxybate

    XYREM Amneal Pharma Europe Ltd

    ORAL FDA: approved Β· EMA: approved

    N07XX04
  19. sodium phenylbutyrate

    PHEBURANE Lacuna Pharma Pty Ltd

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

    A16AX03
  20. sodium thiosulfate

    PEDMARQSI FENNEC PHARMACEUTICALS INC.

    INJECTION FDA: approved Β· EMA: approved

  21. sofosbuvir

    EPCLUSA Teva Pharma GmbH

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

    J05AX15
  22. sparsentan

    FILSPARI Travere Therapeutics

    ORAL FDA: approved Β· EMA: approved

    C09XX01
  23. spironolactone

    ALDACTONE Pfizer Australia Pty Ltd

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

    C03DA01
  24. tacrolimus

    ADVAGRAF XL Alphapharm Pty Ltd

    TOPICAL FDA: approved Β· EMA: approved Β· TGA: approved Β· NMPA: clinical trials

    D11AH01

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.