Belkyra 10 mg/ml solution for injection *
Pharmacy Only: Prescription

  • Company:

    AbbVie Limited
  • Status:

    Updated
  • Legal 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

EDM Updated on 03 October 2023

File name

651bf3914fe28.pdf

Reasons for updating

  • Replace File

Updated on 12 May 2023

File name

645e3158398da.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 May 2023

File name

645e30c5e0f19.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to date of revision

EDM Updated on 16 November 2022

File name

6374b69baffea.pdf

Reasons for updating

  • Replace File

Updated on 01 November 2022

File name

6360f6310b47a.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to date of revision

Updated on 08 April 2022

File name

Belkyra SPC IE_1649432935.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 April 2022

File name

Belkyra PIL IE + MT_1649432886.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 17 September 2021

File name

belkyra-pil-ie-med.ie - V8_1631911818.pdf

Reasons for updating

  • New PIL for medicines.ie

EDM Updated on 04 August 2021

File name

Belkyra IE Injector's Guide 73546FR10-metadata removed_1628076738.pdf

Reasons for updating

  • Add New Doc

Updated on 04 August 2021

File name

belkyra-spc-ccdsv6-ie-clean - V7_1628076610.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

Updated on 04 August 2021

File name

belkyra-pil-ccdsv6-ie-clean - V8_1628076565.pdf

Reasons for updating

  • New PIL for new product