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

  • Company:

    Gerard Laboratories

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to restricted prescription (C)

  • Active Ingredient(s):

    Trastuzumab

    This medicinal product is subject to additional monitoring.

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

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