EU Panel Backs Synflorix Of GlaxoSmithKline For Immunization
January 22 2009 - 1:10PM
Dow Jones News
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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