Fludara 10 mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Sanofi Genzyme
  • Status:

    Updated
  • Legal 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