Recommended wording

Recommended wording for statements on the use of medicinal products in children to be included in SmPCs and PLs

The finalised paediatric assessment reports (PARs) are published on the website of the Heads of Medicines Agencies. The text recommendations contained in the PARs are to be translated into German and included in the relevant sections of the summary of product characteristics (SmPCs) and package leaflets (PLs) of the medicinal products concerned.

It is recommended that the German translations provided under the link given below be used. These translations have been made and published in consultation with the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).