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Aurobindo Pharma Ltd
Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD
Telephone: + 44 (0)208 845 8811
Fax: +44 (0)208 845 8735
WWW: http://www.aurobindo.com
Medical Information Direct Line: +44 (0)208 839 0959
Medical Information e-mail: medinfo@aurobindo.com
Customer Care direct line: +44 (0)208 845 8811
Medical Information Fax: +44 (0)208 845 8795

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 27/01/2012
SPC Sertraline 50mg tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 27/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   02-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
PL number amended as previous SPC contained incorrect PL number
Updated on 28/09/2011 and displayed until 27/01/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   21-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


TO CHANGE THE NAME OF THE MEDICINAL PRODUCT FROM 'SERTRALINE AUROBINDO 50 MG/100 MG FILM-COATED TABLETS' TO 'SERTRALINE 50 MG/100 MG FILM-COATED TABLETS' IN THE UNITED KINGDOM ONLY. CONSEQUENTIALLY, THE LABEL AND PIL HAVE BEEN UPDATED.

Updated on 11/07/2011 and displayed until 28/09/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
Date of revision of text on the SPC:   20-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4 updated to included new information and revised wording.
Updated on 30/11/2010 and displayed until 11/07/2011
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  sertraline hydrochloride