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Hyrimoz 40mg solution for injection in pre-filled pen

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Adalimumab

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

Updated on 02 January 2024

File name

Hyrimoz_REG SPC_PF23-0209_07.08.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 02 January 2024

File name

Hyrimoz 40mg_0.8ml_PFP_REG PIL_PF23-0209_19.09.23_clean_IPHA.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Removal of Black Inverted Triangle
  • Change of manufacturer
  • Change to section 7 - Instructions for use

EDM Updated on 02 August 2023

File name

IE_Hyrimoz_PAEDIATRIC Patient_Card_Apr 22_V3.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 02 August 2023

File name

IE_Hyrimoz_ADULT Patient_Card_Apr 22_V3.pdf

Reasons for updating

  • Add New Doc

Updated on 07 July 2022

File name

Hyrimoz 40mg PFP_REG PIL_October 2021_corr.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 06 July 2022

File name

Hyrimoz 40mg PFP_REG PIL_October 2021.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 July 2022

File name

Hyrimoz_REG SPC_October 2021.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)