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ADARTREL - ADARTREL - CT 7444 - English version

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Introduction ADARTREL 0.25 mg film-coated tablet Box of 12 (CIP: 391 839-4) ADARTREL 0.5 mg film-coated tablet Box of 28 (CIP: 391 840-2) ADARTREL 1 mg film-coated tablet Box of 28 (CIP: 364 452-5) ADARTREL 2 mg film-coated tablet Box of 28 (CIP: 391 844-8) Posted on Feb 08 2010 Active substance (DCI) ropinirole (hydrochloride) ATC Code N04BC04 Laboratory / Manufacturer GLAXOSMITHKLINE ADARTREL 0.25 mg film-coated tablet Box of 12 (CIP: 391 839-4) ADARTREL 0.5 mg film-coated tablet Box of 28 (CIP: 391 840-2) ADARTREL 1 mg film-coated tablet Box of 28 (CIP: 364 452-5) ADARTREL 2 mg film-coated tablet Box of 28 (CIP: 391 844-8) Posted on Feb 08 2010

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Published 10 March 2010
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Language English

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The legally binding text is the original French version 
TRANSPARENCY COMMITTEE  OPINION  10 March 2010  Examination of the dossier of proprietary products registered for a duration of 5 years from 25 May 2005 (OJ of 1 June 2005)  ADARTREL 0.25 mg film-coated tablet Box of 12 (CIP: 391 839-4)  ADARTREL 0.5 mg film-coated tablet Box of 28 (CIP: 391 840-2)  ADARTREL 1 mg film-coated tablet Box of 28 (CIP: 364 452-5)  ADARTREL 2 mg film-coated tablet Box of 28 (CIP: 391 844-8)  Applicant: GlaxoSmithKline  Ropinirole (hydrochloride)  List I ATC code: N04BC04  Date of Marketing Authorisation: 30 June 2004 (mutual recognition procedure) (Country reporter: France)  Date last amended: 1 July 2009  Reason for request: renewal of inclusion on the list of medicines reimbursed by National Insurance. The joint renewal of the REQUIP products is the subject of a separate opinion.  Indication:  “Symptomatic treatment of moderate to severe idiopathic restless legs syndrome (see Pharmacodynamics).” In the Pharmacodynamics section it is stated that: “ADARTREL should only be prescribed to patients with moderate to severe Restless Legs Syndrome. Moderate to severe idiopathic restless legs syndrome is typically represented by patients who suffer with insomnia or severe discomfort in the limbs.”  Note: reminder of the 2004 wording: “Treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) that interferes with sleep and/or has a negative impact on everyday family, social and/or work life.”  Dosage: See SPC (new wording in bold) Adults: RopiniroleIndividual dose titration against efficacy and tolerability is recommended. should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring.Ropinirole may be taken with food, to improve gastrointestinal tolerance.  
 
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