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Last updated on 28/02/2019

Notification of adverse reactions or incidents

PIL and SPC
of a medicine

(PIL: patient information leaflet SPC: summary of product characteristics)

News

17/06/2019

The Oversight Committee on the advertising for medicines for human use is looking for new members

07/06/2019

PRAC May 2019 – Start of referral: Xeljanz (tofacitinib)

07/06/2019

Clarification for the variation or notification procedure for changes to a MA file

04/06/2019

Fees for drug packaging: VAT rules

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