Eloxatin 5mg/ml Concentrate for Solution for Infusion *
Company:
SANOFIStatus:
No Recent UpdateLegal 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
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 29 April 2021
File name
1.3.1 Eloxatin SmPC_1619681957.pdf
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of ‘PA’ prefix to MA number in section 9. No further changes.
Updated on 24 April 2019
File name
PIL Eloxatin 5mg concentration for solution for infusion IE933_1556104208.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 24 April 2019
File name
SPC Eloxatin 5mg concentration for solution for infusion IE933 _1556104423.pdf
Reasons for updating
- 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
4.8. Undesirable effects
MedDRA Organ system classes Injury, poisoning, and procedural complications
Common - Fall
Updated on 10 October 2018
File name
Eloxatin 5mg SmPC pdf_1539159745.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 October 2018
File name
Eloxatin 5mg PL _1539087012.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 12 December 2017
File name
PIL_11556_238.pdf
Reasons for updating
- New PIL for new product
Updated on 12 December 2017
Reasons for updating
- Change to section 6 - manufacturer
Updated on 16 August 2016
Reasons for updating
- Change to side-effects
Updated on 02 August 2016
Reasons for updating
- 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
Delayed hypersensitivity has also been reported with oxaliplatin hours or even days after the infusion.
Skin and Subcutaneous tissue disorders
Post-marketing experience with frequency not known:
Hypersensitivity vasculitis.
Updated on 02 August 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 April 2016
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
Updated on 24 November 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
-Disseminated INtravascular Coagulation reported
-QT prolongation interval should be monitored before and after administration
-Reports of Rhabdomyolysis
4.8
-Musculoskeletal and connective tissue disorders added
-Rhabdomyolysis frequency unknown.
Updated on 11 November 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 03 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 01 April 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Myelosuppressive effects may be additive to those of concomitant chemotherapy. Patient with severe and persistent myelosuppression are at high risk of infectious complications. Sepsis, neutropenic sepsis and septic shock have been reported in patients treated with oxaliplatine including fatal outcomes (see section 4.8.). If any of these events occurs, oxaliplatin should be discontinued.
Section 4.8 updated with information on Infections and infestations
Updated on 14 July 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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
Updated on 07 July 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 14 September 2012
Reasons for updating
- Change to marketing authorisation holder
Updated on 12 September 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 June 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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
4.2 - dosage in renal impairment
4.3 - administrative
4.4 - additional information in renal impairment, hypersensitivity reactions, RPLS & admnistrative
4.8 - additional side effects
Updated on 15 January 2009
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 December 2008
Reasons for updating
- 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
Updated on 17 December 2008
Reasons for updating
- Change to side-effects
- Improved electronic presentation
Updated on 15 July 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 July 2007
Reasons for updating
- Improved electronic presentation
Updated on 15 June 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
- 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 21 March 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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 18 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 19 October 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 10 October 2006
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
Updated on 23 August 2006
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
- 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
Updated on 31 May 2006
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)