Azacitidine Mylan 25 mg/mL powder for suspension for injection * Pharmacy Only: Prescription
Company:
Gerard LaboratoriesStatus:
UpdatedLegal 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 22 February 2023
File name
63f5fcf6a238a.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
63f5fcc5db25c.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
62bc016cd0386.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
62bc012fa4cd3.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_1649069918.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 July 2021
File name
ie-spc-h004984-clean_1627289405.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_1599043608.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_1599043578.pdf
Reasons for updating
- New PIL for new product