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Berlipharm
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland
Telephone: +353 1 299 9313
Fax: +353 1 206 1456
Summary of Product Characteristics last updated on medicines.ie: 11/03/2008
SPC Climara, Climara forte

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 11/03/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • 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:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to Section 4.4: Conditions which need supervision; Addition of "hereditary angioedema"
 
Change to Section 4.8: Undesirable Effects; Addition of "immune system disorders- exacerbation of hereditary angioedema" to the table
 
Section 10: Date of Revision of the text was changed from October 2007 to January 2008.
Updated on 30/11/2007 and displayed until 11/03/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 7. Marketing Authorisation Holder

The marketing authorisation holder was changed from "HE Clissmann T/A Berlipharm, 72 Heather Road, Dublin 18" to "Bayer Limited, The Atrium, Blackthorn Road, Dublin 18"

 

Section 8. Marketing Authorisation Number(s)

The marketing authorisation numbers were changed from "Climara 50 micrograms/24 hours Transdermal Patch: PA 12/79/1, Climara Forte 100 micrograms/24 hours Transdermal Patch: PA 12/79/2" to "Climara 50 micrograms/24 hours Transdermal Patch: PA 1410/15/1, Climara Forte 100 micrograms/24 hours Transdermal Patch: PA 1410/15/2"

 

Section 10. Date of Revision of the Text

The date was changed from "February 2006" to "October 2007"
Updated on 04/07/2006 and displayed until 30/11/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   02/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to SPC following renewal procedure.
 
Main changes include:
 
Section 4.8 UNDESIRABLE EFFECTS
Addition of 'cerebral ischaemic events' as adverse event reported from post marketing experience.
 
Section 5.1 PHARMACODYNAMIC PROPERTIES
Addition of pharmacotherapeutic group and ATC code classification
 
Section 7 MARKETING AUTHORISATION HOLDER
Change of address to: 72 Heather Road, Dublin 18
Updated on 16/08/2005 and displayed until 04/07/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 01/04/2004 and displayed until 16/08/2005
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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 02/07/2003 and displayed until 01/04/2004
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 10/06/2003 and displayed until 02/07/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Estradiol Hemihydrate