Azacitidine Mylan 25 mg/mL powder for suspension for injection
*Company:
Gerard LaboratoriesStatus:
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 27 March 2025
File name
ie-spc-h-4984-MAHT-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 27 March 2025
File name
ie-pl-h-4984-MAHT-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 December 2024
File name
ie-spc-h-4984-r0019-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 12 December 2024
File name
ie-pl-h-4984-r0019-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 29 January 2024
File name
ie-pl-h-4984-v017-clean.pdf
Reasons for updating
- 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 29 January 2024
File name
ie-spc-h-4984-v017-clean.pdf
Reasons for updating
- 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 17 October 2023
File name
ie-spc-h-4984-v016-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 February 2023
File name
ie-pl-h-4984-v011-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 22 February 2023
File name
ie-spc-h-4984-v011-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 June 2022
File name
ie-pl-h-4984-v010-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
Updated on 29 June 2022
File name
ie-spc-h-4984-v010-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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2022
File name
ie-pl-h-4984-v0009-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 July 2021
File name
ie-spc-h004984-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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 02 September 2020
File name
ie-spc-h-4984-en-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 September 2020
File name
ie-pl-h-4984-en-clean.pdf
Reasons for updating
- New PIL for new product
Gerard Laboratories
Address:
Unit 35/36, Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0) 1707 853000 press 1