Marketing authorisations  

December 31, 2009

Number of authorised medicinal products (incl. all formulations and strengths)

3628

In 2008

Number of initial applications received

594

Number of marketing authorisations granted

531

Number of applications for renewal of marketing authorisations

531

Number of marketing authorisations renewed

539

Number of applications withdrawn during the evaluation time and rejected applications (incl. variations)

1082

Number of applications for variations (type I and type II) to authorised products

8337

Number of approved variations

8331

Acting as a reference member state:

Number of procedures

2 CP
14 DCP
3 renewals
13 variations