11 Pages
English
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SIFROL - SIFROL - CT 3918 - English version

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11 Pages
English

Description

Introduction SIFROL 0.088 mg unscored tablets, B/30 - CIP : 363 467.9 SIFROL 0.18 mg scored tablets, B/30 - CIP : 363 469.1 and B/100 - CIP : 363 471.6 SIFROL 0.35 mg scored tablets, B/30 - CIP : 363 472.2 SIFROL 0.7 mg scored tablets, B/30 - CIP : 363 474.5 and B/100 - CIP : 363 475.1 Posted on Jun 24 2009 Active substance (DCI) pramipexole ATC Code N04BC05 Laboratory / Manufacturer BOEHRINGER INGELHEIM SIFROL 0.088 mg unscored tablets, B/30 - CIP : 363 467.9 SIFROL 0.18 mg scored tablets, B/30 - CIP : 363 469.1 and B/100 - CIP : 363 471.6 SIFROL 0.35 mg scored tablets, B/30 - CIP : 363 472.2 SIFROL 0.7 mg scored tablets, B/30 - CIP : 363 474.5 and B/100 - CIP : 363 475.1 Posted on Jun 24 2009

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Published 28 February 2007
Reads 27
Language English

Exrait

     The legally binding text is the original French version  TRANSPARENCY COMMITTEE  OPINION  28 February 2007     SIFROL 0.088 mg unscored tablets, B/30 - cip 363 467.9 SIFROL 0.18 mg scored tablets, B/30 - cip 363 469.1 and B/100 - cip 363 471.6 SIFROL 0.35 mg scored tablets, B/30 - cip 363 472.2 SIFROL 0.7 mg scored tablets, B/30 - cip 363 474.5 and B/100 - cip 363 475.1   Applicant : BOEHRINGER INGELHEIM  Pramipexole  List I  Marketing authorisation dates (centralised procedure): 14 October 1997, 6 April 2006 (extension of indication), 7 August 2006.   Reason for request: Inclusion on the list of medicines reimbursed by National Insurance and approved for use in hospital in the indication: symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt)                        Health Technology Assessment Division  
 
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