Winthrop Pharmaceuticals UK Ltd

One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 554 831
E-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Direct Line: +44 (0)1483 554 101
Medical Information Fax: +44 (0)1483 554 831

Summary of Product Characteristics last updated on the eMC: 18/09/2007
SPC Neulactil 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 18/09/2007 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change of product licence holder to trading style of sanofi aventis

Updated on 21/09/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.1 (List of excipients): Change to the specification of Lactose anhydrous ffrom USP to Ph. Eur.
Updated on 04/08/2006 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03/2003
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 
Section 4.8 (undesirable effects): Liver function: Liver injury has been reported very rarely in in patients treated with pericyazine.
 
Section 4.8 (undesirable effects): Liver function: Neuroleptic jaundice has the biochemical and other characteristics of obstructive (cholestatic) jaundice....
 
Section 4.8 (undesirable effects):  Priapism has very rarely been reported in patients treated with pericyazine.
Updated on 24/09/2004 and displayed until 04/08/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 24/09/2004 and displayed until 24/09/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 24/09/2004 and displayed until 24/09/2004
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   pericyazine