Login

Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Fondaparinux Sodium

    *Additional information is available within the SPC or upon request to the company

Updated on 22 November 2024

File name

ie-spc-2.5mg-h403-v0092-clean.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 04 April 2024

File name

Pages from ie-pl-h403-en-clean-Arixtra (Fondaparinux sodium) 2.5mg.pdf

Reasons for updating

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

Updated on 04 March 2024

File name

ie-combined-h403-en-clean-maht_PIL_2.5.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 04 March 2024

File name

ie-combined-h403-en-clean-maht_smpc_2.5.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 17 October 2023

File name

ie-PIL-h403-en-clean (psusa) 2.5mg_0.5ml.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to other sources of information section

Updated on 17 October 2023

File name

ie-smpc-h403-en-clean (psusa) 2.5mg_0.5ml.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 27 March 2023

File name

ie-smpc-arixtra2.5mg-launch-clean.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 09 March 2023

File name

ema-combined SmPC-h-403-en-clean.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 24 November 2022

File name

ie-pil-h-403-arixtra 2.5 mg -launch.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 November 2022

File name

Arixtra SmPC 2.5mg.pdf

Reasons for updating

  • New SPC for new product

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