ADVATE 2000 IU and 3000 IU powder and solvent for solution for injection 5 ml water - Baxject III

Product Information *

  • Company:

    Takeda Products Ireland 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 11 April 2021

File name

Advate-ie-pl-5-ml-sodium-update-24-Feb-2021-clean_1618177947.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 11 April 2021

File name

Advate-ie-spc-5-ml-sodium-update-24-Feb-2021-clean_1618177834.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 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

The main changes to the SmPC:

Section 2:

Excipients with known effect:

This medicinal product contains 0.45 mmol sodium (10 mg) per vial.

Section 4.4.

Excipient related considerations

Sodium

After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial. To be taken into consideration by patients on a controlled sodium diet. This medicinal product contains 10 mg sodium per vial, equivalent to 0.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Section 10 date of revision: 24 February 2021

Updated on 15 April 2020

File name

Advate-ie-pl-5-ml-BJ-III-T-0106-April 2020-clean_1586961388.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 April 2020

File name

Advate-ie-spc-5-ml-T-0106-02 April 2020-clean_1586961143.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • 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 15 April 2020

File name

Advate-ie-pl-5-ml-BJ-III-T-0106-April 2020-clean_1586961070.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 15 April 2020

File name

Advate-ie-spc-5-ml-T-0106-02 April 2020-clean_1586960909.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder

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

Updated on 04 March 2020

File name

ie-spc-5-ml-clean_1583328298.pdf

Reasons for updating

  • 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 medical prescription which may not be renewed (A)

Updated on 04 March 2020

File name

ie-spc-2-ml-clean_1583328001.pdf

Reasons for updating

  • 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 medical prescription which may not be renewed (A)

Updated on 02 March 2020

File name

ie-pl-2-ml-BJ-III-clean_1583161626.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 02 March 2020

File name

ie-spc-2-ml-clean_1583161355.pdf

Reasons for updating

  • 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 medical prescription which may not be renewed (A)

Updated on 17 September 2018

File name

ie-spc-005-6-15-16-5ml-6Sept18_1537200478.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Section 5.1 (Pharmacodynamic properties), updated with the rewording of information regarding Immune Tolerance Induction (ITI)

Updated on 15 August 2018

File name

ie-pl-015-16-BJIII-5ml-14Jun18_1534264436.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 14 August 2018

File name

ie-pl-015-16-BJIII-5ml-14Jun18-clean_1534244492.pdf

Reasons for updating

  • Change to date of revision

Updated on 14 August 2018

File name

ie-spc-005-6-15-16-5ml-14Jun18-clean_1534247087.pdf

Reasons for updating

  • 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 10 (date of revision of thew text), updated. Change to the joint SPC with UK - ADR statement for UK was updated accoriding to QRD template.

Updated on 14 August 2018

File name

ie-spc-005-6-15-16-5ml-14Jun18-clean_1534246523.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Section 4.2 (Posology and method of administration), deletion of specific information that the use of 2 ml presentations has not been documented for paediatric subjects below 2 years of age.

Updated on 19 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 19 December 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company


  • In section 4.4 (Special warnings and precautions for use), updated with scientific information on inhibitors.
  • In section 4.8 (undesirable effects), updated with scientific information on inhibitors.
  • In section 5.1 (Pharmacodynamic properties), removed scientific information on inhibitor development.
  • In section 9 (DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION), updated with the latest renewal date.

Updated on 14 December 2017

File name

PIL_17211_851.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 December 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 06 July 2017

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 February 2016

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