Zaltrap 25mg/ml concentrate for solution for infusion

  • Name:

    Zaltrap 25mg/ml concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Aflibercept

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/11/19

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Summary of Product Characteristics last updated on medicines.ie: 12/8/2019

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SANOFI

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126 - 150 of 176 items.Total: 8 pages

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 November 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 August 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

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

Updated on 16 July 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

4.8  Undesirable effects - how to report a side effect

Yellow card warning added

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 01 February 2013

Renewal: 21 September 2017

 

 

10.     DATE OF REVISION OF THE TEXT

 

21 September 2017

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu

Updated on 16 July 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 29 May 2018 PIL

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 6 April 2017 SmPC

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

Type II:  Update the Product Information (SmPC, section 5.1 Pharmacodynamic properties) to reflect the results of the biomarker programme encompassing the EFC10262, EFC10668 and EFC11338 studies in order to fulfil the Annex II condition of Zaltrap, aflibercept 25 mg/ml, Concentrate for solution for infusion (EMEA/H/C/002532).

Updated on 6 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 17 November 2016 SmPC

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 4.8 - Undesirable effects

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: additional advisory to discontinue Zaltrap in case of cardiac failure/ejection fraction decreased.

Section 4.4: additional warning on cardiac failure / decreased injection fraction included as below;

Cardiac failure and ejection fraction decreased

Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP. Baseline and periodic evaluations of left ventricular function should be considered while the patient is receiving Zaltrap. Patients should be monitored for signs and symptoms of cardiac failure and ejection fraction decreased.  Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased.

Section 4.8: Cardiac failure added as an uncommon adverse reaction and ejection fraction decreased added as a rare adverse reaction

Updated on 16 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 November 2016 PIL

Reasons for updating

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

Updated on 18 April 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company



Update of sections 4.4 and 4.8 of the SmPC to revise the warning section on proteinuria, and to add a warning on osteonecrosis of the jaw and to add the adverse reaction osteonecrosis of the jaw with a frequency uncommon. The Package leaflet is updated accordingly. 

Updated on 9 January 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 15 December 2014 SmPC

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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Information regarding the use of a filter, including its pore size and material, included in section 4.2 of the SmPC, has been moved to section 6.6.

Updated on 13 August 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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 has had a minor rewording of the recommendation regarding recurrent hypertension.
Section 4.4 updated to amend the existing warnings on proteinuria and warnings on hypertension.

Updated on 30 April 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 31 October 2013 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of black triangle

Updated on 9 July 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation

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 has been updated to include the statement on reporting ADRs.
Section 5.1 has been updated to include the ATC code.

Throughout the SmPC we have replaced 'elderly patients' with 'older people' 

Updated on 14 February 2013 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 12 February 2013 PIL

Reasons for updating

  • New PIL for new product