Talzenna 0.25mg and 1mg Hard Capsules *
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

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

Updated on 20 December 2021

File name

ADV SPC TE 6_0 IE clean_1639987131.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 22 November 2021

File name

ADV SPC TE 5_0 IE clean_1637578596.pdf

Reasons for 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 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

SPC IE and SPC NI has been updated as follows:

4.2 – minor administrative adjustment, 4.4 – MDS/AML reporting rate updates in line with CDS, 5.1 – updated ATC code to L01XK04, 10 – revision dated updated

Updated on 22 November 2021

File name

ADV PIL TE 5_0 IE NI clean_1637578516.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 30 September 2021

File name

DEC202163721_ADV PIL TE 4_0 IE NI clean_1633013552.pdf

Reasons for updating

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

Updated on 03 June 2021

File name

DEC202137014_ADV SPC TE 4_0 IE-clean_1622706164.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 12 November 2020

File name

DEC202070972_ADV SPC TE 3_0 IE clean_1605181654.pdf

Reasons for updating

  • 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)

Updated on 12 November 2020

File name

DEC202070972_ADV PIL TE 3_0 IE clean_1605181582.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 21 August 2020

File name

DEC202055395_ADV SPC TE 2_0 IE clean_1597992807.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life

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

Updated on 20 August 2020

File name

DEC202055395_ADV SPC TE 2_0 IE clean_1597911478.

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 4.2, 4.5, 5.2 have been updated with dosing information in relation to renal impairment and DDI

Please note there are also track changes marked in section 6.3. This change is to increase the shelf-life from 2 years to 3 years.     The details of these changes are given on SCC decision notification DEC202055133.

Updated on 20 August 2020

File name

DEC202055395_ADV PIL TE 2_0 IE clean_1597911382.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Product/presentation re-marketed

Updated on 09 July 2020

File name

ADV SPC TE 1_0 IE_1594287419.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

New Product - Launched 15 July 2020

Updated on 09 July 2020

File name

ADV PIL TE 1_0 IE amended_1594287349.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New Products - Launched 15 July 2020