Vyndaqel 61 mg soft capsules *
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    Updated
  • 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 17 January 2023

File name

63c6857895aad.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

The PIL has been updated with 353 deleted from telephone number for Pfizer Healthcare Ireland (local MA Holder contact details).


Updated on 02 November 2022

File name

63623c00ba3ab.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 03 December 2021

File name

SPC VY 61mg 4_0 IE CLEAN_1638532006.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container

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

Updated on 03 December 2021

File name

PIL VY 61 mg 4_0 IE & NI CLEAN_1638531958.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 18 June 2021

File name

DEC202140435_Adv PIL VY 61 mg 3_0 IE_clean_1624018745.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 15 June 2021

File name

DEC202133418_Adv SPC VY 61mg 3_0 IE clean_1623773053.pdf

Reasons for updating

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

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

Updated on 28 October 2020

File name

Adv SPC VY 61mg 2_0 IE clean_1603904071.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 28 October 2020

File name

DEC202072185_Adv PIL VY 61 mg 2_0 IE clean_1603904011.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 08 September 2020

File name

Adv SPC VY 61mg 1_0 IE clean_1599572405.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

Product Launch

Updated on 08 September 2020

File name

Adv PIL VY 1_0 IE_1599572362.pdf

Reasons for updating

  • New PIL for new product