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Glivec
INN or common name: imatinib
Therapeutic area (MeSH): Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Marketing authorisation issued:
Last updated: 12 November 2025
Revision: 51
Medicine Human Authorised
Datopotamab deruxtecan Daiichi Sankyo
INN or common name: datopotamab deruxtecan
Therapeutic area (MeSH): Carcinoma, Non-Small-Cell Lung
Withdrawal of application:
Last updated: 11 November 2025
Medicine Human Application withdrawn
Slenyto
INN or common name: melatonin
Therapeutic area (MeSH): Sleep Initiation and Maintenance Disorders; Autistic Disorder
Marketing authorisation issued:
Last updated: 11 November 2025
Revision: 14
Medicine Human Authorised
Uzpruvo
INN or common name: ustekinumab
Therapeutic area (MeSH): Psoriasis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative
Marketing authorisation issued:
Last updated: 11 November 2025
Revision: 8
Biosimilar
Medicine Human Authorised
Kaftrio
INN or common name: ivacaftor; tezacaftor; elexacaftor
Therapeutic area (MeSH): Cystic Fibrosis
Marketing authorisation issued:
Last updated: 11 November 2025
Revision: 31
Orphan
Medicine Human Authorised
Norvir
INN or common name: ritonavir
Therapeutic area (MeSH): HIV Infections
Marketing authorisation issued:
Last updated: 11 November 2025
Revision: 71
Medicine Human Authorised
Bimervax
INN or common name: COVID-19 Vaccine (recombinant, adjuvanted)
Therapeutic area (MeSH): COVID-19 virus infection
Marketing authorisation issued:
Last updated: 11 November 2025
Revision: 12
Additional monitoring
Medicine Human Authorised
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