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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: 02/04/2012
SPC Genotropin 5.3mg, 12mg

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 02/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2.QUALITATIVE AND QUANTITATIVE COMPOSITION, Section 4.4 Special warnings and precautions for use, Section 4.8 Undesirable effects, Section 6.2 Incompatibilities, Section 6.5 Nature and contents of container, Section 6.6 Special precautions for disposal and other handling



Updated on 28/03/2012 and displayed until 02/04/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC update to Section 4.3Contraindications and Section 4.4 Special warnings and precautions for use

Updated on 18/03/2011 and displayed until 28/03/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC – Section 7: Marketing Authorisation Holder
Change of ownership from Pharmacia to Pfizer
Updated on 18/10/2010 and displayed until 18/03/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC – Changes to section 4.3 to 4.9 and section 10 of the SPC
Updated on 13/10/2010 and displayed until 18/10/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to section 6.5, 6.6 and section 10 of the SPC
Updated on 05/08/2010 and displayed until 13/10/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes to section 4.1 to 5.1 and 6.4, 6.6, 9 and section 10 of the SPC

 
Updated on 11/05/2009 and displayed until 05/08/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   01-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 (List of excipients) has been updated to add E numbers to excipient names.
Updated on 08/07/2008 and displayed until 11/05/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Sections 2, 6.3 and 6.5 of the SmPC have been updated as part of this variation to reflect the removal of the Kabivial presentation
Updated on 27/02/2008 and displayed until 08/07/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  4.1 – Update to this section

4.2 - Update to this section

10 – Update to this section
Updated on 16/11/2007 and displayed until 27/02/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2 – Update to this section

4.4 - deletion of current elderly statement by addition of new statement

4.5 – Update to spelling of cyclosprorin to ciclosporin

10 – Update to this section
Updated on 25/06/2007 and displayed until 16/11/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Section 4.4  Change of  m-cresol to metacresol

Section 6.1  Change of excipient m-cresol to metacresol

Section 10  Change to date or Partial revision of text
Updated on 15/06/2007 and displayed until 25/06/2007
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Section 6.6 deletion of references to the Jetex Jet Injection device

Section 10 Update to the date of Partial revision of text
Updated on 13/12/2006 and displayed until 15/06/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
6.3 shelf-life extension to 36 months for the 5.3 mg and 12mg cartridges
6.3 extension of the reconstituted shelf life for the 12mg cartridge to 4 weeks
Updated on 25/09/2006 and displayed until 13/12/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of contraindication in PWS patients.
Shelf-life extension to 36 months.
Reconstituted shelf-life extension to 4 weeks for 12 mg presentation.
Updated on 07/11/2005 and displayed until 25/09/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 01/10/2004 and displayed until 07/11/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 16/04/2004 and displayed until 01/10/2004
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 21/01/2004 and displayed until 16/04/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 21/01/2004 and displayed until 21/01/2004
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

 
  somatropin