Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Zoloft

Product name: Zoloft
Also marketed in the EU under the name(s): Besitran, Lustral, Serlain, Sertralina Pfizer, Sertraline Beral, Sertraline Pfizer, Tatig, Tresleen
INN: sertraline
Indication: Sertraline is indicated for the treatment of:
- Major depressive episodes. Prevention of recurrence of major depressive episodes.
- Panic disorder, with or without agoraphobia.
- Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.
- Social anxiety disorder.
- Post traumatic stress disorder (PTSD)
Marketing Authorisation Holder: Not applicable

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/03/2009 Referral EMEA/H/A-30/938 (2009)2483 of 27/03/2009