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

Product Information *

  • Company:

    Gerard Laboratories

  • Status:

    No Recent Update

  • Active Ingredients :

    Glatiramer Acetate

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 11 January 2021

File name

ie-spc-nl3211-r001-clean_1610397244.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_1584701299.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 12 March 2020

File name

ie-spc-nl3211-v011-clean_1584011218.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_1584011141.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_1549441809.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_1549441880.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_1535444047.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 August 2018

File name

ie-spc-nl3211-clean-v004_1535444100.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_1534856853.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 August 2018

File name

ie-spc-nl3777-clean-maa_1534856870.pdf

Reasons for updating

  • New SPC for new product

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