Savene
*Company:
Clinigen Healthcare B.V.Status:
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 26 April 2023
File name
Savene PIL EU_EN 2021.pdf
Reasons for updating
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
No change to PIL content but updated to remove month of January from file name as the current version has a revision date of November 2021
Updated on 30 November 2021
File name
Savene PIL EU_EN Jan 2021.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to Section 4 - change to list of details of national reporting systems to communicate adverse reaction (side effects) - Added Northern ireland in brackets next to United Kingdom
Change to Section 6 - Date of revision changed to 11/2021
Updated on 30 November 2021
File name
Savene SmPC EU_EN Jan 2021.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Change to Section 4.8 - Change to list of details of the national reporting systems to communicate adverse reactions (side effects) - added northern Ireland in brackets next to United Kingdom
Change to Section 10 - Changed date of revision of the text to 24/11/2021
Updated on 27 January 2020
File name
EN Savene PIL Jan 2020.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
date of revision to Jan 2020
Updated on 27 January 2020
File name
EN Savene SmPC Jan 2020.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Appendix V, the list of details of the national reporting systems to communicate adverse reactions (side effects) for use in section 4.8 “Undesirable effects” of SmPC and section 4 “Possible side effects”
Updated on 25 January 2019
File name
Savene PIL-11Jan2019.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 25 January 2019
File name
Savene SPC-11Jan2019.pdf
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
Change to section 7 (Marketing Authorisation Holder), The marketing authorisation for Savene has been transferred from:
Clinigen Healthcare Ltd
Pitcairn House
Crown Square, First Avenue
Burton-on-Trent, Staffordshire
DE14 2WW
United Kingdom
To:
Clinigen Healthcare B.V.
Schiphol Boulevard 359
WTC Schiphol Airport, D Tower 11th floor
1118BJ Schiphol
The Netherlands
Updated on 10 September 2018
File name
Savene_PIL_ema-combined-h-682-en-print-ready-26Jul2018.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 10 September 2018
File name
Savene_SmPC_ema-combined-h-682-en-print-ready-26Jul2018.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
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, 4.6 and 5.3 of the SmPC in order to add a warning on mutagenic activity of dexrazoxane and to update the contraception recommendations based on toxicological data and literature review.
- Update of sections 1, 2, 3, 6.1, 6.3, 6.5 and 6.6 of the SmPC to make administrative amendments to the description of the pharmaceutical form for Savene in order to align with the relevant EDQM standard terms.
- Update to section 4.4 of the SmPC to update the statement on sodium in line with the Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Updated on 21 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 February 2018
Reasons for updating
- 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
6.5: update to remove details of tear-off cap
10: Date of revision of the text included
Updated on 08 December 2017
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- 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
4.1: Editorial updates only.
4.2: Updated to provide a dosage recommendation in patients with moderate to severe renal impairment and editorial updates.
4.4: Updated to refer to new dosage recommendation in patients with moderate to severe renal impairment and editorial updates.
4.5: Updated to indicate relevance of concomitant chemotherapy in the context of live attenuated vaccine administration. Updated with data concerning PK interactions between dexrazoxane and doxorubicin or epirubicin.
4.8: Reporting details for adverse events.
5.2: Updated with information concerning PK in renally impaired patients, and to include PK data for dexrazoxane from patients with extravasation.
5.3: Editorial updates only.
6.5: Updated to indicate that the carton also contains 3 bottle hangers.
6.6: Editorial updates only.
10: Date of revision of the text included.
Updated on 30 November 2017
File name
PIL_16368_117.pdf
Reasons for updating
- New PIL for new product
Updated on 30 November 2017
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 19 June 2015
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
Updated on 17 June 2015
Reasons for updating
- New PIL for medicines.ie