Azacitidine Mylan 25 mg/mL powder for suspension for injection

*
Pharmacy Only: Prescription
  • Company:

    Gerard Laboratories
  • Status:

    Updated
  • Legal 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 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