Fludara 10 mg film-coated tablets
*Company:
Sanofi GenzymeStatus:
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 14 June 2024
File name
S23.464-Fludara 10mg Tablets SmPC- MAH update - Clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 June 2024
File name
1.3.2 Fludara 10mg tablets PIL.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 December 2023
File name
1.3.1 Fludara tablets PIL T1B - Deletion of oral- Clean.pdf
Reasons for updating
- Change to product name
Updated on 21 November 2023
File name
1.3.1 Fludara 10mg Tablets SmPC- T1B deletion of oral - Clean (1).pdf
Reasons for updating
- Change to product name
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 August 2023
File name
IES22 337 Fludara 10mg Tablets SmPC- CCDS V27 clean-EOP.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 August 2023
File name
IE S22 337 Fludara tablets PIL clean_CCDS 27_EOP.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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
Updated on 28 February 2022
File name
IES21 610 Fludara 10mg Tablets SmPC- storage condition update- clean.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 February 2022
File name
IE S21 610 Fludara clean PIL word- Storage condition update.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 13 May 2021
File name
fludara pl 812844 IE1289 Fludara 10mg Tablets PIL mock-up.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
Updated on 13 May 2021
File name
IE1289 Fludara 10mg Tablets SmPC (2).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 May 2019
File name
PIL Fludara Tabs IE758-9.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 May 2019
File name
SPC Fludara 10mg IE758-9.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
7.MARKETING AUTHORISATION HOLDER
Genzyme Europe B.V.
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
Updated on 10 April 2019
File name
PIL Fludara 10mg.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 10 April 2019
File name
SPC Fludara 10mg 2015.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 March 2019
File name
PIL mock up 10mg tablets SA782-3 SA818-19.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 15 March 2019
File name
SPC 10mg film coated tablets SA782-3 SA818-19.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
7 MARKETING AUTHORISATION HOLDER
Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
8 MARKETING AUTHORISATION NUMBER(S)
Updated on 15 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 February 2017
File name
PIL_17091_482.pdf
Reasons for updating
- New PIL for new product