The European Medicines Agency's, or EMEA, Committee for Medicinal Products for Human Use, or CHMP, adopted one positive opinion, recommending the granting of a marketing authorization for Synflorix (pneumococcal polysaccharide conjugate vaccine (adsorbed)), from GlaxoSmithKline Biologicals. Synflorix is indicated for the active immunization against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 2 years of age. EMEA review began on 30 January 2008 with an active review time of 209 days. The Committee adopted a positive opinion for Ribavirin Teva (ribavirin), from Teva Pharma B.V., indicated for the treatment of hepatitis C. The reference product for Ribavirin Teva is Rebetol, which is already authorized in the European Union in the indication applied for. EMEA review began on 28 May 2008 with an active review time of 203 days.

The Committee adopted one positive opinion for an 'informed consent' application for Fertavid (follitropin beta), from Schering-Plough Europe. This type of marketing authorization application requires that reference is made to an authorized medicine and that the marketing authorization holder of this reference product has given consent to the use of the dossier in the application procedure. The reference product for Fertavid is Puregon. EMEA review began on 27 July 2008 with an active review time of 89 days.

The CHMP adopted a negative opinion, recommending the refusal of a marketing authorization for Vedrop (tocofersolan), from Orphan Europe S.A.R.L. Vedrop was intended for the treatment of vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from cystic fibrosis, congenital chronic cholestasis or hereditary chronic cholestasis. EMEA review began on 27 September 2007 with an active review time of 210 days.

The CHMP gave a positive opinion to extend the indication for Protopic (tacrolimus), from Astellas Pharma GmbH, to 'maintenance treatment'. Protopic is currently indicated for short-term and intermittent long-term treatment of moderate to severe atopic dermatitis in adults.

The CHMP recommended that Fareston (toremifene), from Orion Pharma, should not be used in patients at risk of prolonged QT intervals or other heart problems. Fareston is currently authorized in the EU as hormone treatment for hormone-dependent metastatic breast cancer in postmenopausal women.

Referral procedure for methylphenidate-containing medicines concluded Finalizing a review under Article 31 of Directive 2001/83/EC, as amended, the CHMP concluded that methylphenidate-containing medicines remain suitable for the treatment of children aged six years or older and adolescents with attention deficit/hyperactivity disorder (ADHD). The Committee also recommended that the product information be made consistent across the EU so that all patients, carers and prescribers have the same information for safer and more appropriate use of these medicines.

Referral procedure for Atifor Chiesi 12 mcg/Atimos/Forair (Formoterol HFA 12mcg) concluded The CHMP finalized a referral procedure under Article 36 of Directive 2001/83/EC, as amended for Atifor Chiesi 12 mcg/Atimos/Forair (Formoterol HFA 12mcg), intended for the treatment of broncho-obstructive symptoms in asthmatic patients when treatment with corticosteroids is not sufficient. The Committee concluded that these medicines should not be used in children aged from 5 to 12 years because their efficacy could not be demonstrated in this age group. The Committee therefore recommended that the marketing authorizations for these medicines should be changed accordingly.

Article 36 procedures are initiated where one or more Member States consider that there are public health issues relating to a product that may require harmonies regulatory action across the EU.

Referral procedures for Trimetazidine-ratiopharm and Mephatrim concluded The CHMP finalized two referral procedures under Article 29 of Directive 2001/83/EC, as amended, for Trimetazidine-ratiopharm, 35 mg, modified release tablets, (trimetazidine), from ratiopharm GmbH, and for Mephatrim, 35 mg, modified release tablets, (trimetazidine), from Mepha - Investigacao, Desenvolvimento e Fabricacao Farmaceutica, Lda. Both medicines are indicated for the treatment of heart disease. The CHMP concluded that the available data for these two medicines had shown that there is bioequivalence with the reference medicinal product, and that their benefits and risks are taken as being the same as those of the reference product.

The CHMP therefore recommended that they should be granted a marketing authorization in all concerned Member States.

Article 29 procedures are initiated by one or more Member States in cases where an agreement cannot be reached in the context of the mutual recognition procedure or the decentralized procedure.

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