WEZENLA 130 mg concentrate for solution for infusion
*Company:
Amgen Ireland LtdStatus:
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 04 June 2025
File name
en_wezenla_approved_130mg vial_pil_268123.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 04 June 2025
File name
en_wezenla_approved_130mg vial_spc_268123.pdf
Reasons for updating
- 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 - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- 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 21 February 2025
File name
en_wezenla_approved_spc_v03_130mg.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated INN name in Malignancies section of 4.4 & 4.8. Updated brand name in vaccination section of 4.4.
Updated on 06 January 2025
File name
en_wezenla_approved_pil_v04_130mg vial.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL
Updated on 03 January 2025
File name
en_wezenla_approved_spc_v04_130mg.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Amgen Ireland Ltd
Address:
21 Northwood Court, Santry, Dublin D09 TX31, Ireland, 216 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0WA, UKMedical Information E-mail:
gbinfoline@amgen.comTelephone:
+44 (0)1223 420 305Website:
https://www.amgen.co.ukMedical Information Direct Line:
+44 (0)1223 436 441/Freephone: 1800 535160Customer Care direct line:
+44 (0)1223 436441/Freephone: 1800 535160