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Actavis UK Ltd
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
Telephone: +44 (0)1271 311 200
Fax: +44 (0)1271 346 106
WWW: http://www.actavis.co.uk
Medical Information Direct Line: +44 (0)1271 311 257
Medical Information e-mail: medinfo@actavis.co.uk

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: 11/08/2011
SPC Politid XL 75mg Prolonged-release Capsules

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 11/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


These sections have been updated so the SPC is in line with Core Safety Profile and Final Assessment Report from the PSUR worksharing procedure ES/H/PSUR/0017/001 finalised August 2010 and updated September 2010.
Updated on 19/01/2011 and displayed until 11/08/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update SPC and leaflet by implementing the wording concerning the use of the product and the risk of persistant pulmonary hypotension in neonates (PPHN) as agreed by the PhVWP in March 2010.
Updated on 03/07/2009 and displayed until 19/01/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   22-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Correction of incorrect text in section 6.5 (NAture and Contents of Container)
Updated on 21/05/2009 and displayed until 03/07/2009
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   22-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.1 to 5.3 of the SPC have been updated in line with the originator.
Updated on 19/03/2009 and displayed until 21/05/2009
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

 
  venlafaxine hydrochloride