Hulio 40 mg solution for injection in pre-filled syringe

Product Information *

  • Company:

    Gerard Laboratories
  • Status:

    No Recent Update
  • Active Ingredients :

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

    Product subject to restricted prescription (C)

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 28 June 2021

File name

ie-spc-v027 - pen-syringe_1624891293.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 - syringe_1621890965.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to restricted prescription (C)

Updated on 24 May 2021

File name

ie-pl-v026-syringe_1621890315.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 syringe_1616409564.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 syringe SPC_1609765206.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 syringe PIL_1609765167.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 syringe SPC_1603453535.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 syringe PIL_1603453457.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 inj in prefilled syringe-h-4429-en-clean-v015_1586526952.pdf

Reasons for updating

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

Updated on 06 March 2020

File name

Hulio 40mg solution for injection prefilled syringe & pen v0015_1583505251.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 sol for injection prefilled syringe_1572350604.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 syringe_1555073825.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_1555073855.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 syringe PIL_1547727632.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 3 - how to take/use
  • 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_1547727759.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 Syringe_1540303236.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 October 2018

File name

Hulio Combined Smpc Pen plus Syringe_1540303278.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)