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Marketing Authorisations

Anifrolumab (Saphnelo°) in systemic lupus erythematosus after failure of standard therapy

Selumetinib (Koselugo°) in plexiform neuro­fibromas due to neuro­fibromatosis type 1

Filgotinib (Jyseleca°) in ulcerative colitis

Sotorasib (Lumykras°) in non-small cell lung cancer with KRAS G12C mutation

Dabigatran (Pradaxa°) for venous thrombo­­sis in children and adolescents

Degarelix (Firmagon°) in localised or locally advanced prostate cancer

Mepolizumab (Nucala°) in eosinophilic granulomatosis with polyangiitis

Mepolizumab (Nucala°) in certain patients with hypereosinophilic syndrome

Tafasitamab (Minjuvi°) in relapsed or refractory diffuse large B-cell lymphoma

Blinatumomab (Blincyto°) for first relapse of acute lymphoblastic leukaemia in children

Chlormadinone, nomegestrol: risk of meningioma added to the SmPCs for contraceptive products

Adverse Effects

Janus kinase inhibitors: higher incidence of serious adverse effects and death than with TNF-alpha inhibitors

Dutasteride, finasteride: high-grade prostate cancer (continued)

Ondansetron: blindness, often transient

Beta-blockers in eye drops: serious bronchospasm still occurring

Doxylamine: dependence

Zinc or other di- or trivalent cations and bictegravir: virological failure

Common stem: -ac

Outlook

Early and compassionate access to drugs in France

Clinical trials in children: many results go unreported

Better prevention of the harms of drugs during pregnancy

Lack of evidence that "orphan" drugs are a therapeutic advance

Tramadol and codeine: patients unaware of the risks

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