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ORENCIA - ORENCIA - CT 10284 - Version anglaise

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Présentation ORENCIA 250 mg, poudre pour solution à diluer pour perfusion Boîte de 1 flacon - Code CIP : 5708927 ORENCIA 250 mg, poudre pour solution à diluer pour perfusion Boîte de 1 flacon - Code CIP : 5708927 Mis en ligne le 12 févr. 2013 Substance active (DCI) abatacept Code ATC L04AA24 Laboratoire / fabricant Laboratoire BRISTOL-MYERS SQUIBB ORENCIA 250 mg, poudre pour solution à diluer pour perfusion Boîte de 1 flacon - Code CIP : 5708927 ORENCIA 250 mg, poudre pour solution à diluer pour perfusion Boîte de 1 flacon - Code CIP : 5708927 Mis en ligne le 12 févr. 2013

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Published 14 March 2012
Reads 18
Language English
 
 
The legally binding text is the original French version  TRANSPARENCY COMMITTEE
 OPINION  14 March 2012   ORENCIA 250 mg, powder for concentrate for solution for infusion B/1 vial (CIP code: 570 892-7) B/1 vial (CIP code: 580 989-3)   Applicant: BRISTOL-MYERS SQUIBB  abatacept ATC code: L04AA24 (biological therapy)  List I  Prescription conditions:(see section 4) Medicinal product reserved for hospital use. Prescription restricted to specialists(in rheumatology or internal medicine or inpaediatrics).  Date of Marketing Authorisation: 21 May 2007 (centralised procedure)  Amendments to Marketing Authorisation: - January 2010  20(extension of the indication for polyarticular juvenile idiopathic arthritis) - July 2010 (extension of the indication for rheumatoid arthritis – RA as a second 01 line treatment i.e. for those patients with an inadequate response to one or more classic disease-modifying treatments, including methotrexate - MTX) - 08 August 2011 (amendment to prescription and delivery conditions)  Reason for request: - Inclusionhospital use in the extension of the on the list of medicines approved for indication "treatment of RA in patients with an inadequate response to one or more classic disease-modifying treatments, including MTX". - Amendment to inclusion conditions (addition of paediatricians to the list of prescribers and inclusion of a new CIP code).        Medical, Economic and Public Health Assessment Division
 
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