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Human Medicines

This area of the website provides information relating to the regulation of human medicines, including access to product information, pharmacovigilance and the directory of relevant agencies.

HUMAN MEDICINES | RECENTLY PUBLISHED

Added in January 2026 07 January UPDATE - ASMF Worksharing Procedure User…
modified 07/01/2026

Guidance on the work sharing procedure for the assessment of Active Substance…
modified 07/01/2026

Member: vacant Alternate: Rui Pedro da Costa Vilar INFARMEDParque de Saúde de…
modified 19/12/2025

Marta Marcelino INFARMEDParque de Saúde de LisboaAvenida do Brasil, n°…
modified 19/12/2025

List of active substances for which data has been submitted in accordance with…
modified 18/12/2025

IMPLEMENTATION OF THE VARIATIONS FRAMEWORK Marketing authorisation holders…
modified 18/12/2025

Hormone Replacement Therapy - Core SmPC (December 2025) [Track version]Hormone…
modified 18/12/2025

Levonorgestrel intra-uterine devices (LNG-IUDs)SE/H/xxxx/WS/582Date of…
modified 17/12/2025

Nebivolol hydrochloride / amlodipine besilateDate of publication: 17/12/2025
added 17/12/2025

RifabutinEnd of procedure: 20/08/2025Date of publication: 17/12/2025
added 17/12/2025

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

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