Asset Publisher

EU Presidency 2019




EU Presidency







EU Presidency 2019


List of expired marketing authorisations 2019



List of expired marketing authorisations and registrations that have ceased to be valid 8.10.2019
(pdf)


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valamis test-äö

valamis test-äö

Marketing authorisations sininen



Marketing authorisationsNational procedure

If a product does not have a marketing authorisation in another EU country, Norway or Iceland, a marketing authorisation can be applied for...

The marketing authorisation holders to review their medicinal products for the existence of nitrosamine impurities



The marketing authorisation holders to review their medicinal products for the existence of nitrosamine impurities

27.9.2019

European Medicines Agency (EMA) and...

Summaries of risk management plans

Instructions for the submission of Summaries of risk management plans (pdf)
 

Abacavir/Lamivudine Stada (abacavir and lamivudine) (pdf)

Abasaglar (insulin glargine) (pdf)

Abilify...

List of self-medication packages of medicinal products with market authorisations 2015-12-04

List of self-medication packages of medicinal products with market authorisations 2019-09-19

About us


The Finnish Medicines Agency Fimea is the national competent authority for regulating pharmaceuticals. As a central administrative agency operating under the Ministry of Social Affairs and...

Read more: biosimilars


Read more



Biological medicinal products



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