Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal 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
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)