Fludara oral 10 mg film-coated tablets
- Name:
Fludara oral 10 mg film-coated tablets
- Company:
Sanofi Genzyme
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/05/19

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Sanofi Genzyme
Company Products
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 14 May 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 May 2019 SPC
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 PIL
Reasons for updating
- Previous version of PIL reinstated
Updated on 10 April 2019 SPC
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 PIL
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 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product