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Granted and cancelled marketing authorisations 2019



Granted and cancelled marketing authorisations, parallel imported medicinal products and registrations 08/2019 (16.09.2019)(pdf in Finnish)
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List of available biosimilars in Finland

The following biomisimilars were available in the Finnish markets on xx

Download List of available biosimilars in Finland (438KB)

List of expired marketing authorisations 2019



List of expired marketing authorisations and registrations that have ceased to be valid 8.9.2019
(pdf)


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Exemption

If justified, Fimea may grant a batch-specific exemption from the conditions of a marketing authorisation or registration, if a medicinal product is critical for the Finnish pharmaceutical services...

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...

To marketing authorisation holders: The process for notifying shortages will change gradually starting from 1 October 2019



To marketing authorisation holders: The process for notifying shortages will change gradually starting from 1 October 2019

5.9.2019

The marketing authorisation holders’...

Forms: Marketing status





Marketing status








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Transfering marketing authorisation




Transfering marketing authorisation
As stated in the administrative regulation 4/2019, the packages of the old holder and the new one can be simultaneously released for distribution for...

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Ad­min­is­trat­ive sec­tor of the Min­istry of So­cial Af­fairs and Health

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For marketing authorisation holders: the naming of certain liposomal medicinal products must be further specified by 30 September



For marketing authorisation holders: the naming of certain liposomal medicinal products must be further specified by 30 September

30.8.2019

The Name Review Group (NRG)...