Login

CONBRIZA 20 mg film coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Bazedoxifene Acetate

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

Updated on 13 February 2023

File name

DEC202103844_Adv SPC CO 9_2 IE - clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 January 2021

File name

DEC202103844_Adv SPC CO 9_2 IE - clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 - how to report a side effect
  • 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 be renewed (B)

Updated on 20 January 2021

File name

DEC202103844_Adv PIL CO 13_1 IE - clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 06 December 2019

File name

DEC201968425_Adv PIL CO 12_0 IE - clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 15 April 2019

File name

DEC201919308_Adv PIL CO 11_0 IE - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 15 April 2019

File name

DEC201919308_Adv SPC CO 8_0 IE - clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 February 2019

File name

Adv PIL CO 10_0 IE_UK.Clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 13 August 2018

File name

PIL_15232_254.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 13 August 2018

File name

Adv SPC CO 7_0 IE_1.Clean.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 7: Marketing Authorisation Holder updated to new MAH, Pfizer EEIG, Belgium.

Section 10: Date of Revision of Text updated to 08/2018

Updated on 13 February 2017

File name

PIL_15232_254.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 February 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 July 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 July 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.5 administrative updates.  Section 4.8 adverse event update for ‘Eye disorders.’

Updated on 27 July 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 12 April 2016

Reasons for updating

  • Change to MA holder contact details

Updated on 26 June 2015

Reasons for updating

  • Change to MA holder contact details

Updated on 18 June 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Posology and method of administration use – update to align with QRD template.

 

Section 4.8 Undesirable effects – Updated with ADR frequency categories in order to align with current CDS (for Oedema peripheral to ‘Very common’ from ‘Common’, Retinal vein thrombosis to ‘Uncommon’ from ‘Rare’, and Rash and Pruritus to ‘Common’ from ‘Not known’).

Section on reporting of adverse events updated in line with new name and contact details for HPRA.

Section 4.9 Overdose - Updated to delete ‘A few’ from ‘A few case of overdose have been reported’.

Updated on 16 June 2015

Reasons for updating

  • Change to side-effects

Updated on 25 March 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 4.8

Updated on 24 March 2014

Reasons for updating

  • Change to side-effects

Updated on 17 March 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to sections:

Section 2, 4.2-4.8, 5.1, 5.2 & 9

Updated on 11 March 2014

Reasons for updating

  • Change to instructions about missed dose
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to date of revision
  • Improved electronic presentation

Updated on 02 September 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects:

Under the appropriate SOC:

Frequency not known:                  Palpitations

Frequency not known:                  Rash, pruritus

Updated on 28 August 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 03 June 2013

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Section 6.3 is updated to reflect reduce shelf life from 2 years to 18 months

Updated on 07 June 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Labelling update, additional of wording to sections.   

Updated on 01 June 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 03 January 2012

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 23 December 2011

Reasons for updating

  • New PIL for new product