EMA study on prescribing of codeine to children and adolescents for cough and cold

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14397
• EU PAS number:
  EUPAS8639
• Study ID:
  14397
• Official title and acronym:
  EMA study on prescribing of codeine to children and adolescents for cough and cold
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  On 11 April 2014, the European Medicines Agency started a review of codeine-containing medicines when used for cough and cold in children. This follows a previous review of these medicines when used for pain relief in children, which was triggered by concerns over the risk of morphine toxicity. As a result of that review, several measures were introduced in order to minimise the risk of morphine toxicity when using codeine for pain relief. These included a recommendation that children with conditions associated with breathing problems should not use codeine. As the reasons for this recommendation may also apply to the use of codeine for cough and cold in children, an EU-wide review of such use has now been started.The present study is aimed at further determining the utilisation of codeine in real-life practice in the EU to treat cough and colds in children and adolescents.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 14/04/2014

Actual: 14/04/2014

Study start date

Planned: 15/04/2014

Actual: 15/04/2014

Data analysis start date

Planned: 30/04/2014

Actual: 30/04/2014

Date of final study report

Planned: 19/08/2014

Actual: 19/08/2014

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable