WEZENLA 130 mg concentrate for solution for infusion

*
Pharmacy Only: Prescription
  • Company:

    Amgen Ireland Ltd
  • Status:

    Updated
  • Legal 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

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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

Amgen Ireland Ltd