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Swissmedic Annual Report 2018

2018 Annual Report and annual financial statements of the Swiss Agency for Therapeutic Products (Swissmedic)

2018 Annual Report and annual financial statements of the Swiss Agency for Therapeutic Products (Swissmedic)

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24 Market access | Marketing authorisation<br />

Therapeutic area<br />

(ATC)<br />

Active<br />

substances<br />

Product name<br />

Application<br />

Venetoclaxum Venclyxto, film-coated tablets Chronic lymphatic leukaemia (CLL)<br />

Durvalumabum<br />

Imfinzi, concentrate for<br />

solution for infusion<br />

Non-small-cell lung cancer (NSCLC)<br />

Darvadstrocelum<br />

Alofisel, suspension for<br />

injection<br />

Perianal fistulas associated with Crohn’s<br />

disease<br />

Tisagenlecleucelum<br />

Kymriah, cell suspension for<br />

infusion<br />

Acute lymphatic B-cell leukaemia (B-cell ALL<br />

and diffuse large B-cell lymphoma (DLBCL))<br />

Blood and blood-forming<br />

organs<br />

Vonicogum alfa<br />

VEYVONDI, powder and<br />

solvent for solution for<br />

injection<br />

Von Willebrand disease<br />

Emicizumabum<br />

Hemlibra, solution for<br />

injection<br />

Haemophilia A, factor VIII deficiency<br />

Dermatologicals Deoxycholic acid Belkyra, solution for injection Treatment of submental fat<br />

Nervous system Cariprazinum Reagila, capsules Schizophrenia<br />

Brexpiprazolum Rexulti, film-coated tablets Schizophrenia<br />

Stiripentolum Diacomit, capsules Severe myoclonic epilepsy of infancy (SMEI,<br />

Dravet’s syndrome)<br />

Methoxyfluranum<br />

Penthrox, liquid to produce a<br />

vapour for inhalation<br />

Pain management<br />

Opicaponum Ongentys, capsules Parkinson’s disease<br />

Erenumabum<br />

Aimovig, solution for<br />

injection in prefilled syringe<br />

Migraine prophylaxis<br />

Pitolisantum Wakix, film-coated tablets Narcolepsy

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