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URZ1\D REJESTRACJl
PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH
Ul. ZJ\BKOWSKA 41; 03 -736 WARSZAWA; TEL. +48 22 492 II 00; FAX. +48 22 492-11-09
NlP 521-32-14-182
REGON 015249601
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Warszawa, dnia
/11 [RIM]
2011 -03- 0 U
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2011 -03- 17
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Zofia VIz
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Szanowna Pani Minister,
Urzad Rejestracji uprzejmie informuje, iz firma Les Laboratoires Servier pismem z dnia
31.01.2011r., powiadornila
0
wstrzymaniu dystrybucji na terenie Rosji i paiJ.stw sasiadujacych
produktu leczniczego Coaxil, Tianeptinum natricum, tabletki powlekane, numer pozwolenia
3702, podmiot odpowiedzialny Les Laboratoires Servier.
Firma informuje rowniez ,
0
aktualnym braku zagrozenia wstrzymaniem obrotu w/w
produktem leczniczym w krajach Unii Europejskiej .
Z powazaniem,
W zaJaczeniu:
- kopia pisma firmy Les Laboratoires Servier z dnia 31.01.2011r.
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Falek
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RECHERCHE MEDICALE
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COAXILIX> coated tablets (Tianeptine sodium salt 12,5 m
Reg. N° R73702
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Dear Sirs,
Since our last pharmacovigilance analysis on tianept ine (PSUR 2006-2009), there have been some
changes regarding this medicine in Russia and in the countries bordering that country, due to the use
of the product by drug addicts in a region where distribution is not much controlled.
This situation led us to act in cooperation with the Competent Authorities in the elaboration of
restrictive measures, including complete distribution stoP. of the medicine in some countries. Thus the
Marketing Authorization in Georgia was withdrawn by the Marketing Authorization Holder on June 25,
2010. In Russia, the already existing measures have been reinforced in July 2010: tianeptine has been
inserted in the list of psychotropic drugs. The same measure was decided in Ukraine on January 10,
2011 and in Armenia on January 21, 2011.
Discussions are taking place in countries bordering these countries. At the same time, a control policy
has also been enforced in all countries in that region.
In European Union countries, the measures decided by France following the conclusions of the
National Commission on Narcotics and Psychotropic drugs seem to be efficient and, from what we
know, the situation observed in Russia has not been observed in the European Union countries. ~.?-,
those countries.
-have
- --... remained stable i,n __
. --.._----_.
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We follow the situation carefully and remain at your disposal should you need any further information.
Please be informed that this information is also sent to t h c e t e n t Authorities in the
European countries where tianeptine is registered.
Yours faithfully,
Danielle AFRIAT
Regulatory Affairs
Central Europe
P.trid~ERE
Genera/~
Worldwide Regulatory Affairs
Servier conta ct:
Danielle AFRIAT
Les Laboratoires Servier Science Union
6, Place des Pleiades
92415 COURBEVOIE Cedex- Franca- Tel: 33 15572 61 78 - Fax: 33 1 5572 32 21
Cc :
Dr F. Wagniart (EU QP - Therapeutic Safety Director Deputv- Institut de Recherches Internationales Servier)
......