GlaxoSmithKline Consumer Healthcare

980 Great West Road, Brentford, Middlesex, TW8 9GS
Telephone: +44 (0)20 8047 5000
Medical Information Direct Line: +44 (0)20 8047 2500
Medical Information e-mail: customer.relations@gsk.com
Customer Care direct line: +44 (0)20 8047 2700
Medical Information Fax: +44 (0)20 8047 6860

Summary of Product Characteristics last updated on the eMC: 19/03/2009
SPC Imigran Recovery

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 19/03/2009 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:   19-May-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  Change to Marketing Authorisation Number Section 9 to PL 00071/0655
Updated on 09/06/2008 and displayed until 19/03/2009
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-May-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Addition of a warning regarding Medication Overuse Headache to section 4.4
Updated on 15/05/2008 and displayed until 09/06/2008
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:   10-Mar-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In Section 4.8 (undesirable effects), dyspnoea has been added.
Updated on 22/02/2008 and displayed until 15/05/2008
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:   02/2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.6 - Revision of time frame for witholding breast feeding from 24 to 12 hours
Section 10 -Updated to 15/02/08
Updated on 21/08/2007 and displayed until 22/02/2008
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes to Section 4.4 and 4.5 Addition of further information regarding serotonin syndrome
Changes to Section 4.8 Removal of tingling from nervous system disorders, and addition of sensory disturbance including paraesthesia and hypoaesthesia.  Addition of 'or cold' to general disorders and administration site conditions
Updated on 08/06/2006 and displayed until 21/08/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
   sumatriptan succinate