TAMIFLU - TAMIFLU - CT 9677 - English version

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Description

Introduction TAMIFLU 12 mg/ml, powder for oral suspension 1 vial of 30 g (CIP code: 359 963-5) TAMIFLU 75 mg, capsule B/10 (CIP code: 359 962-9) TAMIFLU 45 mg, capsule B/10 (CIP code: 382 016-9) TAMIFLU 30 mg, capsule B/10 (CIP code: 382 015-2) Posted on Nov 02 2011 Active substance (DCI) oseltamivir phosphate Infectiologie - Mise au point Intérêt clinique faible dans le traitement curatif de la grippe sévère ou compliquée d’emblée, ou en cas de facteurs de risque de complications TAMIFLU a l’AMM en prophylaxie post-exposition de la grippe et en traitement curatif de la grippe, s’il est administré dans les premières 48 heures après le début des symptômes.Chez l’enfant de moins de 1 an, il est indiqué uniquement en période de pandémie.En traitement curatif de la grippe, son intérêt clinique est faible dans les formes cliniques sévères ou compliquées d’emblée ou en cas de facteur de risque de gravité.Cette synthèse ne concerne que le traitement curatif de la grippe. Pour en savoir plus, téléchargez la synthèse ou l'avis complet TAMIFLU. ATC Code J05AH02 Laboratory / Manufacturer ROCHE TAMIFLU 12 mg/ml, powder for oral suspension 1 vial of 30 g (CIP code: 359 963-5) TAMIFLU 75 mg, capsule B/10 (CIP code: 359 962-9) TAMIFLU 45 mg, capsule B/10 (CIP code: 382 016-9) TAMIFLU 30 mg, capsule B/10 (CIP code: 382 015-2) Posted on Nov 02 2011

Sujets

• Pédiatrie
• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 02 novembre 2011
• Nombre de lectures: 9
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

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The legally binding text is the original French version     TRANSPARENCY COMMITTEE

  OPINION   2 November 2011     TAMIFLU 12 mg/ml, powder for oral suspension 1 vial of 30 g (CIP code: 359 963-5) TAMIFLU 75 mg, capsule B/10 (CIP code: 359 962-9) TAMIFLU 45 mg, capsule B/10 (CIP code: 382 016-9) TAMIFLU 30 mg, capsule B/10 (CIP code: 382 015-2)     Applicant: ROCHE   Oseltamivir phosphate ATC code: J05AH02   List I   Date of Marketing Authorisation (centralised European procedure): TAMIFLU 12 mg/ml, powder for oral suspension and 75 mg capsule: 20/06/2002  TAMIFLU 30 mg and 45 mg capsule: 19 September 2007 Extension of indication to children under 12 months of age during an influenza pandemic: 23 October 2009   Reason for request:  - Re-assessment of the actual benefit (AB) as a curative influenza treatment during periods of virus circulation and during an influenza pandemic in accordance with article R 163-12 of the Social Security Code. - Extension of indication to children less than 1 year of age during an influenza pandemic   outbreak as curative and prophylactic treatment of influenza.               Medical, Economic and Public Health Assessment Division

 

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TC assessment

Curative treatment  

Post-contact prophylaxis        

Exceptional situation

             

Previous assessments from the Transparency Committee: AB, IAB

Opinion dated 21 June 2006 Opinion dated 3 January 2007 Inclusion request  Submission of new studies:  Opinion from 5 December 2007 Opinion dated 11 February 2004 preventative in children Extension of the treated population Inclusion of 30 mg and 45 mg capsules  (extension of indication) + (Ministry of Health referral) and curative Revision of the AB        Confirmation ofi   Insufficient  of rmation AB in all situations from insufficientAB in all 12 months of age  a al g l  e  situations fro n m s   u 1 ff 2 i   ci m e o n n t m 12 months of age isuttaoisnf or of  onfi C ht s n i BA     InsufficientAB in the adolescent and InsufficientAB in children and adults adult without comorbidity Insufficient  without comorbidity AB in children without  comorbidity LowAB in the following high-risk patients: Low  children AB in the adolescent and adult over 1 year of age with comorbidity,  with comorbidity and in subjects over LowAB in children with  adults from 13 to 64 years of age with 65 years of age comorbidity LowAB in the following populations comorbidity and adults over 65 years of age.  g ModerateAB in the particular case of at-risk unable to under o influenza   ModerateAB in the adolescent andModerate  vaccination AB in children with  subjects: for medical reasons: adult with comorbidity and in subjects  comorbidity in particular situations:  - Patients with asthma and chronic - subjects living in institutions( over 65 years of age in particular institutionalised patients,  obstructive pulmonary disease,  institutionalised patients) situations: contraindication to the vaccine,  - Persons staying in medium or long-  - subjects with contraindication to the - institutionalised patients, immunocompromised subjects,  term stay facilities of whatever age-  vaccine   contraindication to the vaccine, incomplete  vaccine protection children and adolescents (from 1 to - immunocompromised subjects(in immunocompromised subjects,  compared to the circulating strain.  18 years) whose health status particular AIDS subjects, transplant incomplete vaccine protection  requires prolonged treatment by recipients or patients receiving compared to the circulating strain. IAB V in the management of post-  acetylsalicylic acid.  immunosuppressive drugs)  exposure prophylaxis children  - situations in which the vaccine only  om 1 to 12 years  provides limited protection against the fr IAB III relative to Mantadix  circulating strain SubstantialAB (conditional) in the seasonal prophylaxis in an exceptional situation: epidemic situation with    - - - mismatch between the vaccine and circulating strains, pandemic situation  

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TC assessment

Curative treatment

Post-contact prophylaxis

Exceptional situation  

 

Opinion dated 16 April 2008 Re-assessment of the AB at the request of the Ministry of Health COSMOS observational study + other data provided

  Confirmation ofinsufficientAB in all situations from 12 months age  

  Opinion dated 21 October 2009 Re-inclusion Submission of six new studies

  Confirmation ofinsufficientAB in all situations from 12 months of age  

InsufficientAB in children and adults without comorbidity    c C o o m nfi o r r m bi a d t i i t o y  n       of insufficientAB in children and adults without LowAB in the following high-risk populations: children over 1 year of age with comorbidity, adults from 13 to 64 years of age with  c C h o il n d f r ir e m n  a o ti v o e n r     o 1 f     y l e o a w r  k of complicatio:n   f oe aghtiwmoc ibroytid64o  t31 morf stluda ,  iABpoe thn noitalupsir ta s comorbidity and adults over 65 years of age. Moderate and adults over 65 years of age. AB in the particular case of at-risk  years of age with comorbidity   subjects: Confirmation  ofmoderateAB in the particular case of at-risk . - subjects living in institutions( institutionalised  subjects: - p  s at u ie bj n e t c s t )  s    with contraindication to the vaccin - -     s s u u b b j j e e c c t t s s    l w iv it in h  g c  i o n n  i tr n a s i ti n t d u i t c io at n i s o (  n i   n to s   ti t t h u e ti   o v n a a c l c i i s n e e d    patients)   e -  immunocompromised subjects (in particular AIDS subjects, - A   I i D m S m  s u u n b o j c e o ct m s, p   r tr o a m n i s s p e l d a   nt s   u re bj c e ip c i t e s  nt (i s n     or p  p ar a t t i i c e u n l t a s r     transplant recipients or patients receiving immunosuppressive drugs)  receiving immunosuppressive drugs)  - situations in which the vaccine only provides limited protection e only provides  against the circulating strain - situations in which the vaccin limited prot tion against the circulating strai ec n

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