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Livial

*
Pharmacy Only: Prescription

  • Company:

    Organon Pharma (Ireland) Limited

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Tibolone

    *Additional information is available within the SPC or upon request to the company

Updated on 31 January 2023

File name

IE-LIVIAL-EN-SPC-MAT-20210730-CRT.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 September 2021

File name

Livial 2.5 mg LFT MAT 2021 CRT.pdf

Reasons for updating

  • Change of manufacturer

Updated on 26 August 2021

File name

IE-LIVIAL-EN-SPC-MAT-20210730-CRT.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 August 2021

File name

QRD-IE-LIVIAL-EN-PIL-MAT CRT.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 23 September 2020

File name

QRD-IE-LIVIAL-EN-PIL-PRAC-CRT (002).pdf.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 23 September 2020

File name

IE-LIVIAL-EN-SPC-PRAC-CRT (002).pdf.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to the product information following conclusion of signal assessment by PRAC regarding the known risk of breast cancer with hormone replacement therapy (HRT).

Updated on 20 July 2018

File name

Livial Proposed PIL MAH Transfer Jul 2018 (2).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 17 July 2018

File name

IE-LIVIAL-EN-SPC-20180706-CRT (2).pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to 7. Marketing Authorisation Holder, Change to section 8 - Marketing authorisation number(s) and Section 10 – Date of revision of the text following approval of MA Transfer from NV Organon to Merck Sharp & Dohme Ireland (Human Health) Limited

Updated on 07 July 2016

File name

PIL_9565_236.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 July 2016

Reasons for updating

  • Change to improve clarity and readability

Updated on 21 April 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 April 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 4.4 – Special warnings and precautions for use, 4.8 Undesirable effects and section 10 Date of revision of the text


Detailed SPC change information: updates to section 4.4 – Special warnings and precautions for use, 4.8 Undesirable effects and section 10 Date of revision of the text following approval of a PRAC recommendation on Ovarian Cancer


Updated on 20 April 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 14 May 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 – addition of the ‘Reporting of suspected adverse reactions’ paragraph at the end of the section
Section 10 – last revision date change to April 2015 

Updated on 13 May 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 07 November 2013

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 16 April 2013

Reasons for updating

  • Correction of spelling/typing errors

Updated on 12 April 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change due to user-testing of patient information

Updated on 05 March 2013

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.3 - Contraindications
  • Change to section 4.1 - Therapeutic indications

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to sections: 4.1, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 10
Updates to sections for Therapeutic indications, contraindications, interaction with other medicinal products and other forms of interaction, Undesirable effects, overdose, date of revision of text.

Updated on 19 July 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

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 18 July 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 13 May 2009

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties

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 22 January 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 15 January 2009

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 August 2008

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 12 August 2008

Reasons for updating

  • Change to improve clarity and readability

Updated on 20 June 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 19 June 2006

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 April 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 April 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 January 2005

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 September 2004

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 02 August 2004

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)