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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 04/01/2012
SPC SOMAVERT 10mg, 15mg & 20mg powder and solvent for solution for injection

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 04/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update section 4.8 Undesirable Effects with the addition of systemic hypersensitivity reactions as a listed undesirable effect.
Updated on 16/06/2011 and displayed until 04/01/2012
Reasons for adding or updating:
  • Change to Legal category
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Legal Category has been removed from the SPC.

 
Updated on 29/11/2010 and displayed until 16/06/2011
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SmPC – The Black Triangle has been removed from Section 1 of the SmPC. Since we maintain a combined Somavert SmPC for UK and Ireland, the labelling for both markets is affected by this change.

Updated on 11/02/2010 and displayed until 29/11/2010
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   02-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


 

5.3 Preclinical safety data (submission of a non-clinical carcinogenicity report and the related updates in section 5.3 of the SPC)

 
Updated on 19/06/2008 and displayed until 11/02/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The shelf life of the product has been extended from two to three years.
Updated on 22/01/2008 and displayed until 19/06/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

4.2 – Update to section

4.8 – Update to section and Addition of text

6.5 - Update to Section

9 - Update to Section

10- Update to Section

Updated on 06/11/2007 and displayed until 22/01/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

2 – Update to Section 2

4.2 - addition of “There is no experience in children”

4.5:  revision to interaction studies statement

4.5 – revision of wording under “Use in Lactation”

4.8 – Update Section 4.8 (Undesirable effects)

5.1 - Update to Section 5.1 (Pharmacotherapeutic group)

6.2 - Update to Section 6.2

6.4 – Update to Section 6.4

6.6 - Update to Section 6.4
Updated on 21/02/2005 and displayed until 06/11/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 12/05/2004 and displayed until 21/02/2005
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 10/05/2004 and displayed until 12/05/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  pegvisomant