Ogivri 150 mg powder for concentrate for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to restricted prescription (C)
  • Active Ingredient(s):

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

Updated on 10 August 2023

File name

64d4c966caa0f.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 10 August 2023

File name

64d4c8967686a.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 4.6 - 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 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to restricted prescription (C)

Updated on 28 October 2021

File name

ie-spc-h4916-150mg-v037-clean_1635410868.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 28 October 2021

File name

ie-spc-h4916-150mg-v037-clean_1635410150.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 24 August 2021

File name

ie-pl-h4916-t0034-clean_1629817557.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 24 August 2021

File name

ie-spc-h4916-150mg-t0034-clean_1629817453.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 10 August 2021

File name

ie-spc-h4916-150mg-v035-clean_1628600507.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 10 August 2021

File name

ie-pl-h4916-v035-clean_1628600348.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Change to storage instructions

Updated on 23 March 2021

File name

ie-spc-h4916-150mg-v026-clean_1616516577.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 23 March 2021

File name

ie-pl-h4916-v026-clean_1616516546.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to storage instructions

Updated on 07 February 2020

File name

ie-spc-h4916-150mg-v010-clean_1581068645.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Updated on 07 February 2020

File name

ie-pl-h4916-v010-clean_1581068622.pdf

Reasons for updating

  • New PIL for new product