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STABLON (tianeptine), antidépresseur - STABLON - CT 10411 & 12029 - Version anglaise

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20 Pages
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Présentation STABLON 12,5 mg, comprimé enrobé B/30- Code CIP : 3400932933914 B/100- Code CIP : 3400955833604 Mis en ligne le 30 août 2013 Substance active (DCI) tianeptine sodique Psychiatrie - Mise au point Maintien au remboursement malgré le risque de pharmacodépendance STABLON a l’AMM dans le traitement des états dépressifs majeurs (c’est à dire caractérisés).Une persistance des cas d’abus et de pharmacodépendances à la tianeptine ont été observés. Cependant, l’ANSM a estimé que le rapport bénéfice/risque de la tianeptine restait favorable,tout en renforçant les conditions de prescription et de délivrance de STABLON, en limitant notamment à 28 jours la durée de la prescription, qui doit être réalisée sur une ordonnance sécurisée ;et en demandant une étude chez la personne âgée, pour laquelle on dispose de peu de données. Compte tenu de ces éléments, la Commission considère que le service médical rendu par STABLON reste important dans les épisodes dépressifs majeurs (c’est-à-dire caractérisés). Code ATC N06AX14 Laboratoire / fabricant SERVIER STABLON 12,5 mg, comprimé enrobé B/30- Code CIP : 3400932933914 B/100- Code CIP : 3400955833604 Mis en ligne le 30 août 2013

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Published 05 December 2012
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Language English

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The legally binding text is the original French version 
  TRANSPARENCYCOMMITTEE Opinion 5 December 2012    STABLON 12.5 mg, coated tablet B/30 (CIP code: 34009 329 339-1 4) B/100 (CIP code: 34009 558 336-0 4) Applicant: SERVIER
INN
ATC Code (2012)
Reason for the review
List(s) concern
Indication(s) concerned     
ed
tianeptine
N06AX14 (Other antidepressants)
Re-assessment of Actual Benefit at the request of the Transparency Committee Renewal of inclusion
B/30 National Health Insurance(French Social Security Code L.162-17) Hospital use(French Public Health Code L.5123-2) B/100 Hos ital useFrench Public Health Code L.5123-2
“Major depressive episodes (i.e. typical).”
HAS - Medical, Economic and Public Health Assessment Division
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01ADMINISTRATIVE AND REGULATORY INFORMATION 
 Marketing Authorisation (national procedure)
Prescribing and dispensing conditions/special status
  
ATC Classification
 
06/02/1987
List I. Duration of prescription restricted to 28 days. To be prescribed written out fully on a secure prescription. Overlap prohibited except on the express instruction of the prescriber written on the prescription. A copy of the prescription to be held by the pharmacist for 3 years.
2012 N N06 N06A N06AX N06AX14
02BACKGROUND 
Central nervous system Psychoanaleptics Anti-depressants Other Anti-depressants Tianeptine
Tianeptine is an antidepressant, the exact mechanism of action of which is not known. It is clinically similar to the tricyclic antidepressants and to amineptine which was withdrawn from the French market in 1999 because of abuse and drug dependence and because of its hepatic (cholestatic injuries) and cutaneous (acne) adverse effects.1 STABLON has been marketed in France since 1989 for the treatment of major depressive episodes (i.e. typical). In 2005, STABLON underwent an addiction vigilance survey which led to the addition of a warning about the risk of abuse and dependence in the SPC and patient leaflet. In April 2011, the National Narcotics and Psychotropics Committee found persisting cases of tianeptine abuse and drug dependence and requested that the benefit/risk ratio of the substance be re-assessed. On 2 February 2012, the National Marketing Authorisation Committee considered that the benefit/risk ratio for tianeptine remained positive but tightened the prescribing and dispensing conditions for the substance. Since 3 September 2012 STABLON has been subject to part of the narcotics regulations (secure prescription, prescription length restricted to 28 days).  In view of the new drug dependence findings, in November 2011, the Transparency Committee expressed a wish to re-assess the actual benefit of STABLON.  
03THERAPEUTIC INDICATION 
“Major depressive episodes (i.e. typical).”
                                               1  Report of the National Pharmacovigilance Committee meeting on 24 January 2012. www.ansm.sante.fr 
HAS - Medical, Economic and Public Health Assessment Division
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