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Brabio 20mg/ml solution for injection, pre-filled syringe

*
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Glatiramer Acetate

    *Additional information is available within the SPC or upon request to the company

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)