Login

Hulio 40 mg/0.8 ml solution for injection

Product Information *

  • Company:

    Gerard Laboratories

  • Status:

    No Recent Update

  • Active Ingredients :

    adalimumab

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

    Product subject to restricted prescription (C)
  • undefined
  • undefined
  • undefined
  • undefined

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 25 May 2021

File name

ie-pl-v026-vial_1621927165.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 May 2021

File name

ie-spc-v026-vial_1621892121.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Legal category:Product subject to restricted prescription (C)

Updated on 24 May 2021

File name

ie-pl-v026-vial_1621891796.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 22 March 2021

File name

Hulio 40mg_0.8ml solution for injection_1616409727.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 04 January 2021

File name

Hulio 40 mg_0.8 mL solution for injection SPC_1609764908.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 restricted prescription (C)

Updated on 04 January 2021

File name

Hulio 40 mg_0.8 mL solution for injection PIL_1609764665.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 23 October 2020

File name

Hulio 40mg_0.8ml sol for inj SPC_1603453717.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 restricted prescription (C)

Updated on 23 October 2020

File name

Hulio 40mg_0.8ml sol for inj PIL_1603453690.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 10 April 2020

File name

ie-40mg sol for injection-h-4429-en-clean-v015-2_1586526773.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 06 March 2020

File name

Hulio 40mg_0.8ml solution for injection v0015_1583505423.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 29 October 2019

File name

Hulio 40mg_0.8ml sol for injection_1572350696.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 13 August 2019

File name

ie-pl-h-4429-en-clean-v007 (002)_1565691641.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 August 2019

File name

ie-spc-h-4429-en-clean-v007_1565691664.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)