Jyseleca®

Active substance     Filgotinib
Holder Impatients N.V.

Submission of an application for a general activity authorisation

There is no predefined form for applying for a general authorisation for the manufacturing, import or distribution of raw materials.
To obtain such an authorisation, the company must submit a written application drawn up on the company’s official letterhead and signed using a qualified electronic signature. The application must be sent electronically to eudragmdp@fagg-afmps.be, with the following subject: “Application for raw materials activity authorisation – company name.”

Additional information

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