European Medicines Agency: Committee for Medicinal Products for Human Use 18 – 21 October 2004

19 October 2004

The Committee adopted three positive opinions on initial marketing authorisation applications for:

• Avastin (bevacizumab), from Roche Registration Ltd, for the treatment of metastatic carcinoma of the colon or rectum. EMEA review began on 22 December 2003, with an active review time of 202 days.
• Fendrix (Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)), from GlaxoSmithKline Biologicals SA, for active immunisation against hepatitis B virus infection for patients with renal insufficiency, from the age of 15 years onwards. EMEA review began on 26 May 2003 with an active review time of 168 days.
• Quintanrix (combined vaccine), from GlaxoSmithKline Biologicals SA, for primary vaccination of infants and for booster vaccination of young children against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and invasive disease caused by Haemophilus influenzae type b. EMEA review began on 23 June 2003 with an active review time of 215 days.

The Committee also adopted the extensions of indication for medicinal products that are already marketed in the European Union.

• Intron A and Viraferon (interferon alfa-2b) , Schering-Plough Europe, to extend the use to the treatment of chronic hepatitis C in children over three years in combination with rabavirin. Intron A and Viraferon were first authorised in the European Union on 9 March 2000.
• Rebetol (ribavirin), Schering Plough Europe, to extend the use to the treatment of chronic hepatitis C in children over three years in combination with interferon alfa-2B. Rebetol was first authorised in the European Union on 7 May 1999.
• Vfend (voriconazole), Pfizer Limited, to extend its use to the treatment of candidemia in nonneutropenic patients. Vfend was first authorised in the European Union on 19 March 2002.

CHMP to review COX-2 inhibitors
Following the worldwide withdrawal of Vioxx (rofecoxib), the European Medicines Agency has been asked by the European Commission, as a precautionary measure, to conduct a review of COX-2 inhibitor medicines.

The CHMP, the Agency's scientific committee responsible for human medicines, will look at all aspects of cardiovascular safety of the COX-2 inhibitors celecoxib, etoricoxib, lumiracoxib, parecoxib and valdecoxib, including thrombotic events (e.g. heart attack and stroke) and cardio-renal events (e.g. hypertension, oedema and cardiac failure). A separate press release has been issued and is available [here].

Start of referral procedure
The CHMP began two Community-wide review procedures under Article 30 of the Community code on human medicines:

• A referral for Neurontin (gabapentin) and associated names was initiated by Italy to harmonise the divergent summaries of product characteristics across the European Union, especially with regard to the indications. Gabapentin is authorised in some Member States for treatment of partial epilepsy and neuropathic pain and in others only for the treatment of epilepsy.
• A referral for Calcium Sandoz Effervescent tablets, 500/1000 mg, from Novartis Consumer Health SA was initiated on request of the marketing authorisation holder to harmonise the divergent summaries of product characteristics across the EU.

A more detailed CHMP meeting report will be published shortly.

European Medicines Agency: Committee for Medicinal Products for Human Use 18-21 October 2004

Reference Number: EMEA/116066/2004