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Marketing Authorisations

Nemolizumab (Nemluvio°) in atopic eczema or prurigo nodularis

Delgocitinib cream (Anzupgo°) in chronic hand eczema

Crizotinib (Xalkori°) in ALK-positive systemic anaplastic large cell lymphoma or unresectable inflammatory myofibroblastic tumours, from 1 year of age

Seladelpar (Lyvdelzi°) in primary biliary cholangitis

Vosoritide (Voxzogo°) in achondroplasia from 4 months of age

Ciltacabtagene autoleucel (Carvykti°) as second-line treatment in multiple myeloma

Adverse Effects

Hydroxyzine: increased incidence of hospitalisation for injuries or cardiovascular disorders

Gliflozins: ketoacidosis (continued)

Ribociclib: multiple, sometimes serious, cutaneous adverse effects

GLP-1 agonists: Wernicke encephalopathy

Low dose levonorgestrel IUDs: ectopic pregnancy (continued)

Dasatinib and other BCR-ABL inhibitors: pulmonary arterial hypertension

Ceftriaxone: biliary lithiasis common, but rarely serious

Bisphosphonates: acute angle-closure glaucoma

Gliflozins: necrotising fasciitis of the perineum (continued)

Common stem: -steride

Outlook

Joint clinical assessment of drugs and medical devices at European level

Contaminated medical fentanyl in Argentina: at least 173 deaths

European Commission fines companies involved in a cartel concerning an active pharmaceutical ingredient

Free  The EMA can still do more to improve official drug information documents

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