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
Medical Information Fax:

Summary of Product Characteristics last updated on the eMC: 05/07/2011
SPC Neotigason 10mg 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 05/07/2011 and displayed until Current
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

To update the relevant SPC sections in line with agreed Core Safety Profile following Periodic Safety Update Report worksharing procedure
Updated on 03/02/2011 and displayed until 05/07/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

SPC replaced with the most current version, date of revision changed from Oct 2008 to 10/11/2010.
Updated on 30/12/2008 and displayed until 03/02/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



To register a change in imprints on the finished product, from 'ROCHE' on the cap and body of the capsule to the Actavis logo on the cap and the pharmaceutical strength on the body of the capsule.

Updated on 24/09/2008 and displayed until 30/12/2008
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

 
   acitretin