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Hulio 40 mg solution for injection in pre-filled pen *
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to restricted prescription (C)

  • Active Ingredient(s):

    Adalimumab

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

Updated on 19 September 2023

File name

65097ea3c674b.pdf

Reasons for updating

  • 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 - interactions with other medicines, food or drink
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 19 September 2023

File name

65097e461b5f1.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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Removal of Black Inverted Triangle

Legal category:Product subject to restricted prescription (C)

Updated on 19 September 2023

File name

65097df646fea.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to restricted prescription (C)

Updated on 19 September 2023

File name

65097d7f8caff.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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 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)