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Medicines for human use under evaluation

Each month, the European Medicines Agency's (EMA) publishes an updated list of medicines for human use currently under evaluation by EMA’s Committee for Medicinal Products for Human Use (CHMP) to obtain a marketing authorisation in the European Union (EU).

Last updated: 18 November 2025
Human Medicines
Viread
INN or common name: tenofovir disoproxil
Therapeutic area (MeSH): Hepatitis B, Chronic; HIV Infections
Marketing authorisation issued:
Last updated: 18 November 2025
Revision: 61
Medicine Human Authorised
Hirobriz Breezhaler
INN or common name: indacaterol
Therapeutic area (MeSH): Pulmonary Disease, Chronic Obstructive
Marketing authorisation issued:
Last updated: 18 November 2025
Revision: 21
Medicine Human Authorised
Oslif Breezhaler
INN or common name: indacaterol
Therapeutic area (MeSH): Pulmonary Disease, Chronic Obstructive
Marketing authorisation issued:
Last updated: 18 November 2025
Revision: 20
Medicine Human Authorised
Onbrez Breezhaler
INN or common name: indacaterol
Therapeutic area (MeSH): Pulmonary Disease, Chronic Obstructive
Marketing authorisation issued:
Last updated: 18 November 2025
Revision: 20
Medicine Human Authorised
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
INN or common name: efavirenz; emtricitabine; tenofovir disoproxil
Therapeutic area (MeSH): HIV Infections
Marketing authorisation issued:
Last updated: 18 November 2025
Revision: 18
Generic
Medicine Human Authorised
Prevenar 20 (previously Apexxnar)
INN or common name: pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
Therapeutic area (MeSH): Pneumococcal Infections
Marketing authorisation issued:
Last updated: 18 November 2025
Revision: 12
Additional monitoring
Medicine Human Authorised
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