Orphan designation: post-authorisation

The pages listed below are relevant for sponsors of medicines that have obtained orphan designation and are at the post-authorisation stage of the product lifecycle.

In this section

In other sections

Sponsors of designated orphan medicines at the post-authorisation stage should also consider the regulatory information in the sections below:

 

Topics

How useful was this page?

Add your rating
Average
6 ratings
1 rating
13 ratings