Metalyse 5 000 units (25 mg)
*Company:
Boehringer Ingelheim LimitedStatus:
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 24 April 2025
File name
Metalyse 25mg PIL Text WF.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 24 April 2025
File name
M10;25mg-EU-SPC-2 medicines ie.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- The country list in the title of the SmPC has been revised to remove reference to Northern Ireland
- Section 4.8: Removal of United Kingdom (Northern Ireland) AE reporting details
- Section 10: Date of revision of the SmPC has been updated to April 2025.
Updated on 30 April 2024
File name
Metalyse 25mg PIL Text -II-0070.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product
Updated on 30 April 2024
File name
M10;25mg-EU-SPC-1 medicines.ie.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
New SmPC for new product.
Boehringer Ingelheim Limited
Address:
The Crescent Building, , Northwood, Santry, Dublin 9Medical Information E-mail:
medinfo.bra@boehringer-ingelheim.comTelephone:
+353 1 295 9620Fax:
+353 1 816 3642