Amvuttra 25 mg solution for injection in pre-filled syringe
*Company:
Alnylam UK Ltd.Status:
UpdatedLegal 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 09 June 2025
File name
Amvuttra- IE-PIL- Helios-B.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Revised PIL to include changes from CM indication.
Updated on 09 June 2025
File name
Amvuttra-IE-SmPC- Helios-B.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Revisions to the SmPC to include the CM indication changes
Updated on 10 February 2025
File name
AMVUTTRA_IE-PIL- Clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Updated on 10 February 2025
File name
AMVUTTRA _IE -SmPC- Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 December 2024
File name
AMVUTTRA _IE-SmPC-EN-CLN.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 February 2023
File name
Amvuttra PIL.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2023
File name
Amvuttra SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Alnylam UK Ltd.
Address:
Braywick Gate, Braywick Road, Maidenhead SL6 1DA, United KingdomMedical Information E-mail:
medinfo@alnylam.comMedical Information Facsimile:
+44 (0) 1255 444 400Medical Information Direct Line:
+44 1628878592