Based on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and on the position of the Coordination Group (CMDh), the European Commission decided on 25 September 2013 to adapt the Summaries of Product Characteristics/Package Leaflets for the marketing authorisations of medicinal products containing diclofenac to the scientific state of the art. In a notice dated 4 December 2013, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled that these texts are to be adapted accordingly.

To the graduated plan procedure (available in Germann only)