16.10.2015 - Ascertainment decision ("Feststellungsbescheid") within the graduated plan procedure ("Stufenplanverfahren")

Treatment of cough in children younger than 12 years with medicinal products containing codeine is no longer permitted due to the risk of respiratory depression.

19.06.2015 - Notice within the graduated plan procedure ("Stufenplanverfahren")

In a notice dated 17 June 2015, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the implementation of the corresponding decision of the Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) on medicinal products containing codeine.

24.04.2015 - CMDh position

The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has unanimously endorsed the recommendation issued by the Pharmacovigilance Risk Assessment Committee (PRAC).

13.03.2015 - PRAC recommendation

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends restrictions on the use of the active substance codeine for treatment of cough and cold in children and adolescents because of the risk of serious side effects including the risk of breathing problems.

11.04.2014 - Procedure started

At the request of the BfArM, the European Medicines Agency (EMA) has initiated a review procedure regarding the basic evaluation of the benefit-risk balance of medicinal products containing codeine for treatment of cough in children and adolescents.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):