Prasugrel Viatris 10 mg film-coated tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 March 2025
File name
ie-pl-h-4644-local rep change for PL-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 29 April 2024
File name
ie-pl-h-4644-name change_maht -clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 29 April 2024
File name
ie-spc-h-4644-name change_maht-clean_MD.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 March 2023
File name
ie-pl-renewal-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 22 March 2023
File name
ie-spc-renewal-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 January 2022
File name
ie-spc-shelflife-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 October 2021
File name
ie-pl-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 22 October 2021
File name
ie-spc-maht-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 October 2019
File name
IE leaflet clean text (v003).pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 21 March 2019
File name
ie-pl-h-4644-en-v002-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 21 March 2019
File name
ie-spc-h-4644-en-v002-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1