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Organon Laboratories Limited
(Merck Sharp & Dohme Ireland (Human Health) Limited), P.O. Box 2857, Drynarn Road, Swords, Co Dublin, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 19/07/2011
SPC Livial

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 19/07/2011 and displayed until Current
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:   09-Apr-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Change to Section 7 - Marketing Authorisation Holder
Change to Section 8 - Marketing Authorisation Number
Change to Section 10 - Date of Revision of the Text
Updated on 13/05/2009 and displayed until 19/07/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   30-Apr-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
in section 4.3-  the contrindication has been expanded to state that tibolone increased the risk of breast cancer recurrance in a placebo-controlled trial.

in section 5.1- Deletion of information on the in vitro effects of tibolone from this section
Updated on 15/01/2009 and displayed until 13/05/2009
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 4.5 - 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 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update to clinical sections of the SPC following the review of findings of the LIFT and Thebes clinical studies.
Updated on 12/08/2008 and displayed until 15/01/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2 Update text inline with SPC guideline

Section 6.1 Update to excipient name

Section 6.5 Update text inline with SPC guideline

Section 6.6 Update section heading

Section 10 Update to date of revision 

 
Updated on 19/06/2006 and displayed until 12/08/2008
Reasons for adding or updating:
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Extra warnings added
Section 4.3 - Contraindications added
Section 4.4 - Extra warnings and precautions added
Section 4.6 - Further data added
Section 4.8 - More detail added re undesirable effects
Section 5.1 - Clinical trial information updated
Section 10 -  Date of revision updated
Updated on 27/04/2005 and displayed until 19/06/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Updated on 25/01/2005 and displayed until 27/04/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 15/09/2004 and displayed until 25/01/2005
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 4.3 - 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Updated on 02/08/2004 and displayed until 15/09/2004
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 4.1 - Therapeutic indications
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 19/06/2003 and displayed until 02/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Tibolone