Login

gammanorm

*
Pharmacy Only: Prescription

  • Company:

    Octapharma Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Human Normal Immunoglobulin

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

Updated on 09 February 2023

File name

Gammanorm IE SPC - 20200903 - Oct 2020.pdf

Reasons for updating

  • Document format updated

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

Updated on 23 October 2020

File name

Gammanorm IE SPC - 20200903 - Oct 2020.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 23 October 2020

File name

Gammanorm IE PIL - 20200903 - Oct 2020.pdf

Reasons for updating

  • 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 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 15 August 2018

File name

Gammanorm IE SPC - June 2018.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 11 June 2018

File name

Gammanorm IE SPC - June 2018.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 11 June 2018

File name

Gammanorm IE PIL - June 2018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 07 February 2018

File name

PIL_16235_274.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 07 February 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

- Section 4.1: More detail given regarding therapeutic indications$0- Section 4.2: Rapid push has been added as a method of administration (i.e. subcutaneous infusion using a syringe)$0$0- Section 4.4: More detail has been given regarding Contraindications $0$0- Section 4.6: Crosses the placenta increasingly during third trimester$0$0- Section 4.7: May impair ability to drive$0$0- Section 4.8: Undesirable effects has been re-written, with addition of new tabulated list of adverse reactions$0$0- Section 5.1: Addition of a new clinical study$0

Updated on 07 February 2018

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 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 01 March 2016

Reasons for updating

  • Change of manufacturer

Updated on 10 November 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

4.8 - change of wording to one side effect$04.8 - updated HPRA contact information$0$010 - Updated date of revision of text$0

Updated on 11 February 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.8: Inclusion of Thromboembolic events as Vary rare ADR

Section 10: Updated revision of text.

Updated on 11 February 2015

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 March 2014

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided