VYDURA 75 mg oral lyophilisate
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)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 April 2025
File name
Adv SPC VD 5_0 IE_clean.pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
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 5.2: Minor update in the Cmax value from 42 to 41 under Effects of food subsection.
Section 5.2: Minor update to add “2C8” in the sentence “rimegepant is not an inhibitor of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or UGT1A1 at clinically relevant concentrations” under Biotransformation subsection.
Updated on 17 April 2025
File name
Adv PIL VD 5_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 23 January 2024
File name
AdvPILVD40IEclean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 January 2024
File name
AdvPILVD40IEclean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 June 2023
File name
Adv SPC VD 40 IE clean.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 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 June 2023
File name
Adv PIL VD 30 IE clean.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 24 March 2023
File name
Adv SPC VD 3_0 IE clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 January 2023
File name
Adv PIL VD 2_0 IE clean.pdf
Reasons for updating
- New PIL for new product
Updated on 18 January 2023
File name
Adv SPC VD 2_0 IE clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
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