Vyndaqel 61 mg soft capsules
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal 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 26 February 2025
File name
clean Adv PIL VY 61 mg 9_0 IE.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 20 February 2025
File name
clean Adv PIL VY 61 mg 9_0 IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 10 April 2024
File name
Adv PIL VY 61 mg 80 IE NI CLEAN.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 20 February 2023
File name
Adv SPC VY 61mg 5_0 IE CLEAN.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 February 2023
File name
Adv PIL VY 61mg 7_0 IE NI CLEAN.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
SPC VY 61mg 4_0 IE CLEAN.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2023
File name
AdvPILVY61mg60IENICLEAN (1).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
AdvPILVY61mg50IENIclean.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.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.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.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.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.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.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.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.pdf
Reasons for updating
- New PIL for new product
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363