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Hulio 40 mg/0.8 ml solution for injection *
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories

  • Status:

    Updated

  • Legal Category:

    Product subject to restricted prescription (C)

  • Active Ingredient(s):

    Adalimumab

    This medicinal product is subject to additional monitoring.

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

Updated on 28 September 2022

File name

6334253548753.pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 28 September 2022

File name

633424fc19307.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to restricted prescription (C)

Updated on 24 November 2021

File name

ie-pil-h-4429-en-clean-vmaht-solution_1637749406.pdf

Reasons for updating

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

Updated on 24 November 2021

File name

ie-spc-h-4429-en-clean-vmaht -solution_1637749370.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

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)