Desferal 500mg Vials Powder for Solution for Injection or Powder for Concentrate for Solution for Infusion
*Company:
Novartis Ireland LimitedStatus:
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
Updated on 20 August 2021
File name
Desferal PIL 02.2021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 November 2019
File name
Desferal 500mg Vials 700437_IE_Word Version_IPHA.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 22 January 2019
File name
Desferal 500mg Vials 700437_IE_p3_LFT_X-4 RA approved 05.09.2018 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 24 July 2018
File name
Desferal 500mg Vials REGSPC PF 18-0179 July 2018_Clean.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 July 2017
File name
PIL_8498_175.pdf
Reasons for updating
- New PIL for new product
Updated on 20 July 2017
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 28 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 June 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 6.3, the shelf-life has been changed from 18 Months to 36 Months
In section 6.4, the storage conditions have been changed from "Do not store above 30°C" to "Do not store above 25°C"
Updated on 19 May 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to improve clarity and readability
Updated on 18 June 2015
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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
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
Typographical changes have been made
Section 4.4 Special warnings and precautions for use
In Section 4.8 Undesirable effects
Additional side effects have been added
Information on how to report ADRs has been added
In Section 6.3 Shelf life
Shelf life has been changed from 4 years to 18 Months
In Section 6.4 Special precautions for storage
Storage conditions has been changed from to “Store below 25 °C” to “Do not store above 30 °C”
Updated on 09 December 2014
Reasons for updating
- Change due to user-testing of patient information
Updated on 27 January 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
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.2 Posology and method of administration;
Information for use in the elderly has been given. Additional information on method of administration by Continuous intravenous infusion has been given.
In Section 4.4 Special warnings and precautions for use; a warning for patients with renal impairment has been added.
Section 4.6 Fertility, pregnancy and lactation; has been fully updated.
Section 4.8 Undesirable effects; has been fully updated.
In Section 5.2 Pharmacokinetic properties; Information on clinical studies has been provided.
Section 6.2 Incompatibilities; has been updated.
Section 6.3 Shelf life; information on shelf life has been expanded.
Section 6.4 Special precautions for storage; has been updated.
Section 6.5 Nature and contents of container; has been updated.
Section 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product; has been fully updated.
Updated on 27 June 2013
Reasons for updating
- Change to side-effects
Updated on 28 February 2013
Reasons for updating
- PIL re-instated
Updated on 25 June 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 May 2005
Reasons for updating
- Improved electronic presentation
- PIL retired pending re-submission
Updated on 24 August 2004
Reasons for updating
- New PIL for medicines.ie