Zaltrap 25mg/ml concentrate for solution for infusion
*Company:
SANOFIStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 November 2024
File name
1.3.2.1 Mock-up Leaflet - Zaltrap (aflibercept) IE and UK(NI) (7).pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 11 November 2024
File name
1.3.2.1 Mock-up Leaflet - Zaltrap (aflibercept) IE (1).pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 11 November 2024
File name
1.3.2.1 Mock-up Leaflet - Zaltrap (aflibercept) IE (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 24 January 2024
File name
1.3.1.1 SmPC - Zaltrap UK(NI), IE and MT (1).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 January 2024
File name
1.3.1.1 SmPC - Zaltrap UK(NI), IE and MT.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 January 2024
File name
1.3.2.1 Mock-up Leaflet - Zaltrap (aflibercept) IE and UK(NI).pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 11 October 2023
File name
1.3.1 SPC Zaltrap UK(NI), IE and MT -(Clean).pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 October 2023
File name
1.3.2 Zaltrap (aflibercept) IE and UK(NI) leaflet - (Clean).pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 21 February 2023
File name
Zaltrap (aflibercept) IE and UK(NI) leaflet (4).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 10 January 2023
File name
1.3.1 SPC Zaltrap UK(NI), IE and MT (1).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 January 2023
File name
Zaltrap (aflibercept) IE and UK(NI) leaflet.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 22 July 2022
File name
Zaltrap (aflibercept) IE and UK(NI) leaflet (3).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 19 July 2022
File name
Zaltrap (aflibercept) IE and UK(NI) leaflet (1).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 09 December 2021
File name
1.3.2 Zaltrap IE-MT Uk IE PIL TEXT.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 08 January 2021
File name
1.3.1 SPC Zaltrap (2).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 January 2021
File name
1.3.2 Mock-up PIL Zaltrap IE-MT.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 January 2020
File name
1.3.1 SPC Zaltrap.pdf
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
|
Section 4.4 -Special warnings and precautions for use: Aneurysms and artery dissections The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections. Before initiating [product name], this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Section 4.8 - Undesirable effects: Tabulated list of adverse reactions Vascular disorders: Frequency 'Not known': Aneurysms and artery dissections |
Updated on 11 November 2019
File name
Zaltrap PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 12 August 2019
File name
Zaltrap 25mg ml concentrate for solution for infusion SPC.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 July 2018
File name
Zaltrap 25mg ml concentrate for solution for infusion SPC.docx
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
File name
Zaltrap 25mg ml concentrate for solution for infusion PIL.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 29 May 2018
File name
1.3.1 PIL text-clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 06 April 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2017
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
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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 17 November 2016
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
File name
PIL_15633_888.pdf
Reasons for updating
- New PIL for new product
Updated on 16 November 2016
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
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 09 January 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 15 December 2014
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
Updated on 13 August 2014
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 4.4 updated to amend the existing warnings on proteinuria and warnings on hypertension.
Updated on 30 April 2014
Reasons for updating
- Change to further information section
Updated on 31 October 2013
Reasons for updating
- Change to further information section
- Change to date of revision
- Addition of black triangle
Updated on 09 July 2013
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 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
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
Updated on 12 February 2013
Reasons for updating
- New PIL for new product