Brabio 20mg/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 17 January 2025
File name
ie-spc-nl3211-v022-v023-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 November 2024
File name
ie-spc-nl3211-v022-v023-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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 22 November 2024
File name
ie-spc-nl3211-v022-v023-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 22 November 2024
File name
ie-pl-nl3211-v022-v023-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 08 August 2024
File name
ie-spc-nl3211-pr3299761-maht-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 November 2023
File name
ie-pl-nl3211-pr3299761-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 27 November 2023
File name
ie-pl-nl3211-pr3299761-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 27 November 2023
File name
ie-pl-nl3211-pr3299761-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 27 November 2023
File name
ie-spc-nl3211-v018-clean.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 15 November 2022
File name
ie-pl-nl3211-v018-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 November 2022
File name
ie-spc-nl3211-v018-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- 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 2022
File name
ie-pl-nl3211-v017-rtq-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 04 April 2022
File name
ie-spc-nl3211-v017-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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)
Updated on 11 January 2021
File name
ie-spc-nl3211-r001-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 20 March 2020
File name
ie-pl-nl3211-v011-rtq-clean.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 12 March 2020
File name
ie-spc-nl3211-v011-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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 March 2020
File name
ie-pl-nl3211-v011-rtq-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 06 February 2019
File name
ie-pl-nl3211-mahtransfer-clean.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 06 February 2019
File name
ie-spc-nl3211-mahtransfer-clean.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 28 August 2018
File name
ie-pl-nl3211-clean-v006.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 28 August 2018
File name
ie-spc-nl3211-clean-v004.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 August 2018
File name
ie-pl-nl3777-clean-maa.pdf
Reasons for updating
- New PIL for new product
Updated on 21 August 2018
File name
ie-spc-nl3777-clean-maa.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1