Fludara oral 10 mg film-coated tablets

Product Information *

  • Company:

    Sanofi Genzyme
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

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 13 May 2021

File name

fludara pl 812844 IE1289 Fludara 10mg Tablets PIL mock-up_1620909019.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)_1620908960.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_1557820536.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 May 2019

File name

SPC Fludara 10mg IE758-9_1557820613.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_1554904532.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 10 April 2019

File name

SPC Fludara 10mg 2015_1554900528.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_1552649621.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_1552649855.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