gammanorm

Product Information *

  • Company:

    Octapharma Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 23 October 2020

File name

Gammanorm IE SPC - 20200903 - Oct 2020_1603445277.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_1603444994.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_1534341513.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

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

  • 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 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 07 February 2018

File name

PIL_16235_274.pdf

Reasons for updating

  • New PIL for new product

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