STELARA - STELARA - CT 8633 - English version

Has

Description

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

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-traitement-medicamenteux
• Publié le: 22 juin 2011
• Nombre de lectures: 33
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

 

 

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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