Vumerity 231mg Gastro Resistant Capsules
*Company:
Biogen Idec (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 July 2026
File name
IE SmPC renewal.pdf
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Administrative updates in line with QRD template as part of 5-year renewal.
Updated on 23 July 2026
File name
IE leaflet renewal.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Update to leaflet as part of 5-year renewal. Section 4: Text relating to low levels of white blood cells has been moved from very common to common section. Minor typographical updates in the same section.
Updated on 18 February 2025
File name
IE updated Vumerity PIL Art61_3 QRD 10.4 update.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change of distributor details
- Removal/change of distributor
Free text change information supplied by the pharmaceutical company
- Deletion of 'United Kingdom (Northern Ireland)' from the list of local representatives in the Package Leaflet
- Correcting details for the local representative in Denmark and Bulgaria
- Change to section 6 - date of revision
Updated on 15 October 2024
File name
IE-NI updated Vumerity PIL ESTEEM cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 October 2024
File name
IE-NI updated Vumerity SmPC ESTEEM cl.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 June 2024
File name
IE NI PIL June 2024.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 January 2024
File name
IE-NI updated SmPC Vum SL 32 mths.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 not be renewed (A)
Updated on 08 September 2023
File name
IE-NI SPC Aug 23.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 not be renewed (A)
Updated on 01 February 2023
File name
IE-NI PIL Feb 23.pdf
Reasons for updating
- New PIL for new product
Updated on 01 February 2023
File name
IE-NI SPC Feb 23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Biogen Idec (Ireland) Ltd
Address:
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, IrelandMedical Information E-mail:
MedInfoUKI@biogen.comMedical Information Direct Line:
1800 812 719