Minutes of the Pharmacovigilance Working Party's meeting held on 21-23 September.

08 January 2010

The Pharmacovigilance Working Party (PhVWP) under EMEA's Committee for Medicinal Products for Human Use (CHMP) held its September 2009 plenary meeting on 21-23 September 2009.

The PhVWP is an expert working group which meets every month at the European Medicines Agency (EMEA) in London to discuss safety surveillance of medicines (pharmacovigilance) in the EU.

The topics on the agenda of the PhVWP's September plenary meeting included:

  • Apomorphine - Risk of QT interval prolongation.
  • Ceftriaxone - Harmonisation of contraindications in newborns and risk of calcium-ceftriaxone precipitation when administered/mixed with solutions containing calcium. Ceftriaxone and calcium-containing solutions contraindicated in newborns in certain conditions and not to be mixed or administered simultaneously for intravenous use in patients of any age.
  • Vigabatrin - Risk of movement disorders with or without abnormalities shown in brain magnetic resonance imaging (MRI).
  • Monitoring of side effects from medicinal products used against influenza A (H1N1) virus in humans.
  • Guideline on the Conduct of Pharmacovigilance for Vaccines for Pre- and Post-Exposure Prophylaxis against Infectious Diseases.
  • Worksharing between Member States for the assessment of periodic safety update reports.

In the factbox to the right, you can find the PhVWP's monthly report from its September plenary meeting and the publication policy for the monthly reports of the PhVWP.  

Stay up to date with the latest news from the PhVWP meetings in Danish Pharmacovigilance Update from the Danish Medicines Agency.
The news from the meetings of the PhVWP will in future be brought in Danish Pharmacovigilance Update, which is a newsletter on medicine and side effects issued by the Danish Medicines Agency. (see the factbox to the right).

For further information, please contact Doris I. Stenver, tel. +45 4488 9247 or email dis@dkma.dk.

Danish Medicines Agency, 11 November 2009