King Pharmaceuticals Ltd

Donegal Street, Ballybofey, County Donegal,
Medical Information Direct Line: +44(0)1438 356924
Medical Information Fax: +44 (0)1438 727805

Summary of Product Characteristics last updated on the eMC: 14/06/2010
SPC ALLEGRON

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 14/06/2010 and displayed until Current
Reasons for adding or updating:
  • 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:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In section 4.8 addition of class effect warning
In section 10 date of revision updated
Updated on 13/03/2008 and displayed until 14/06/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes requested by MHRA to include warnings re suicial thoughts and behaviour
Updated on 27/11/2007 and displayed until 13/03/2008
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   nortriptyline hydrochloride