CHMP and CMDh news – March 2014


CMDh endorses PRAC’s recommendations to restrict the use of diacerein-containing medicines

The Co-ordination Group for Mutual Recognition and Decentralised Procedure - Human (CMDh) has endorsed recommendations to restrict the use of diacerein-containing medicines. Diacerein is a medicine used to treat joint diseases such as osteoarthritis and its use has been restricted due to the risks of severe diarrhoea and liver problems.

There is no approved diacerein-containing medicinal products in the Republic of Croatia.

You may read more on the restrictions on use of diacerein on the EMA webpages or here.

CHMP recommended nine new medicines for approval

The Committee for Human Medicinal Products (CHMP) has recommended granting a marketing authorisation for nine new medicines by endorsing the following recommendations:

for Vynfinit (vintafolide) for the treatment of women with a sub-type of platinum-resistant ovarian cancer. The CHMP has also recommended approval of two companion diagnostic medicines, Folcepri (etarfolatide) and Neocepri (folic acid) that will help identify patients who may benefit from the treatment with Vynfinit. All three of these medicines have an orphan designation and were recommended by the CHMP for conditional marketing authorisations.

  • for Sylvant (siltuximab) for the treatment of Castleman’s disease; the medicinal product has an orphan designation;
  • for Entyvio (vedolizumab) for the treatment of ulcerative colitis and Crohn’s disease;
  • for Jardiance (empagliflozin) for the treatment of type 2 diabetes;
  • for Olysio (simeprevir) for the treatment of chronic hepatitis C in adult patients in combination with other medicinal products;
  • for Revinty Ellipta (fluticasone furoate/vilanterol trifenatate) for the treatment of asthma and chronic obstructive pulmonary disease
  • for the generic medicine Ebilfumin (oseltamivir) for the prevention and treatment of influenza.

Other CHMP recommendations from March 2014

The CHMP recommended extensions of indications for Pegasys, Tresiba and Victoza. The CHMP concluded its review of the safety of propylene glycol in intravenous formulations for short-term use in children. The assessment report for this review will be published in the next days. The CHMP adopted EU-wide recommendations for the influenza virus strains that should be included in vaccines for the prevention of seasonal influenza in winter 2014/2015.

You may read more about the CHMP meeting held in March 2014 on the EMA webpages, or here.