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Hulio 40 mg solution for injection in pre-filled pen *
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

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 24 November 2021

File name

ie-pil-h-4429-en-clean-vmaht-pen_1637749316.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-pen_1637749276.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 19 October 2021

File name

ie-spc-h-4429-en-clean-v032(pack sizes-alcohol pads)_1634640070.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to restricted prescription (C)

Updated on 19 October 2021

File name

ie-pl-h-4429-en-clean-v032(pack sizes-alcohol pads)_1634640014.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 28 June 2021

File name

ie-spc-v027 - pen-syringe_1624891327.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 restricted prescription (C)

Updated on 24 May 2021

File name

ie-spc-v026 - pen_1621891518.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-pen_1621891243.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 solution for injection in pre filled pen_1616409609.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 solution for injection in pre-filled pen SPC_1609765099.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 solution for injection in pre-filled pen PIL_1609765060.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 sol for inj prefilled pen SPC_1603453653.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 sol for inj prefilled pen PIL_1603453614.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 06 March 2020

File name

Hulio 40mg solution for injection prefilled syringe & pen v0015_1583505362.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

Huilio 40mg sol for injection prefilled pen_1572350656.pdf

Reasons for updating

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

Updated on 12 April 2019

File name

Hulio 40mg sol for injection in prefilled pen_1555073790.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 April 2019

File name

ie-SPC-h-4429-en-clean-v007_1555072432.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 17 January 2019

File name

40mg pen PIL_1547727276.pdf

Reasons for updating

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

Updated on 17 January 2019

File name

40mg pen & syringe SPC_1547727339.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 23 October 2018

File name

Hulio Package leaflet for Pen_1540303358.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 October 2018

File name

Hulio Combined Smpc Pen plus Syringe_1540303391.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)