STELARA - STELARA - CT 8633 - English version

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Introduction STELARA 45 mg, solution for injection, 0.5 mL in vial B/1 (CIP code: 392 586-2) STELARA 45 mg, solution for injection, 0.5 mL in pre-filled syringe B/1 (CIP code: 374 848-9) STELARA 90 mg, solution for injection, 1 mL in pre-filled syringe B/1 (CIP code: 374 849-5) Posted on Jan 24 2013 Active substance (DCI) ustekinumab ATC Code L04AC05 Laboratory / Manufacturer JANSSEN-CILAG STELARA 45 mg, solution for injection, 0.5 mL in vial B/1 (CIP code: 392 586-2) STELARA 45 mg, solution for injection, 0.5 mL in pre-filled syringe B/1 (CIP code: 374 848-9) STELARA 90 mg, solution for injection, 1 mL in pre-filled syringe B/1 (CIP code: 374 849-5) Posted on Jan 24 2013

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Published 22 June 2011
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The legally binding text is the original French version  
TRANSPARENCY COMMITTEE  OPINION  22 June 2011    STELARA 45 mg, solution for injection, 0.5 mL in vial B/1 (CIP code: 392 586-2)  STELARA 45 mg, solution for injection, 0.5 mL in pre-filled syringe B/1 (CIP code: 374 848-9)  STELARA 90 mg, solution for injection, 1 mL in pre-filled syringe B/1 (CIP code: 374 849-5)   Applicant: JANSSEN-CILAG  Ustekinumab ATC Code: L04AC05  List I Initial six-month hospital prescription. Initial prescription and renewal restricted to specialists in dermatology or internal medicine.   Date of Marketing Authorisation: 16 January 2009    Reason for request: Re-assessment of actual benefit in accordance with article R163-12 of the Social Security code following submission of new clinical data (long-term patient follow-up).           Medical, Economic and Public Health Assessment Division
 
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