DYNEPO - DYNEPO - CT 4163 - English version

Has

Description

Introduction DYNEPO 1,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 629-8) DYNEPO 2,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 630-6) DYNEPO 3,000 IU/0.3 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 631-2) DYNEPO 4,000 IU/0.4 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 632-9) DYNEPO 10,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 633-5) DYNEPO 2,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 634-1) DYNEPO 3,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 635-8) DYNEPO 4,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 636-4) DYNEPO 10,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 637-0) Posted on Nov 10 2009 Active substance (DCI) epoietin delta ATC Code B03XA Laboratory / Manufacturer SHIRE FRANCE S.A. DYNEPO 1,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 629-8) DYNEPO 2,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 630-6) DYNEPO 3,000 IU/0.3 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 631-2) DYNEPO 4,000 IU/0.4 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 632-9) DYNEPO 10,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 633-5) DYNEPO 2,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 634-1) DYNEPO 3,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 635-8) DYNEPO 4,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 636-4) DYNEPO 10,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 637-0) Posted on Nov 10 2009

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-traitement-medicamenteux
• Publié le: 28 février 2007
• Nombre de lectures: 14
• 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   28 February 2007     DYNEPO 1,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 629-8) DYNEPO 2,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 630-6) DYNEPO 3,000 IU/0.3 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 631-2) DYNEPO 4,000 IU/0.4 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 632-9) DYNEPO 10,000 IU/0.5 ml, solution for injection in pre-filled syringe B/6 (CIP: 359 633-5)   DYNEPO 2,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 634-1) DYNEPO 3,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 635-8) DYNEPO 4,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 636-4) DYNEPO 10,000 IU/ml, solution for injection in vial B/10 vials (CIP: 359 637-0)   Applicant: SHIRE FRANCE S.A.   epoietin delta   ATC code: B03XA   List I Medicinal product for which the initial 1-year hospital prescription is restricted to specialists in nephrology, haematology and internal medicine or doctors practising in units for home-based dialysis.    Date of Marketing Authorisation (centralised procedure): 18 March 2002   Reason for request: Inclusion on the list of medicines reimbursed by National Insurance and approved for use by hospitals.       Medical, Economic and Public Health Assessment Division

 

1