Fludara 50 mg powder for solution for injection or infusion *

  • Company:

    Sanofi Genzyme
  • Status:

    No Recent Update
  • 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

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

File name

PIL Fludara IV IE758-9_1557820561.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 May 2019

File name

SPC Fludara IV IE758-9_1557820676.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 IV 50_1554904459.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 10 April 2019

File name

SPC Fludara IV 2015_1554900483.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 Fludara 50mg SA782-83 and SA818-19 (1)_1552649537.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 50mg powder for solution for injections or infusion SA782-3 SA818-9_1552649752.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 09 March 2016

File name

PIL_14654_323.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 March 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 20 January 2016

Reasons for updating

  • New SPC for new product

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

Updated on 20 January 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

.

Updated on 23 December 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 17 February 2012

Reasons for updating

  • Change to name of manufacturer

Updated on 12 April 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • 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

Changes made to the following sections:

4.2    Posology and method of administration

Addition of sub heading ‘Posology’

Addition of sub heading ‘Special populations’

Changed sub heading from ‘Children’ to ‘Paediatric population’

Changed  “In patients over the age of 70  years, creatinine clearance should be measured...” to “In patients over the age of 65 years, creatinine clearance should be measured...”

4.4    Special warnings and special precautions for use

Addition of - In patients aged 65 years or older, creatinine clearance should be measured before start of treatment, see “Renal impairment” and section 4.2.

Addition of final paragraph – Excipients - Each vial Fludara 50 mg powder for solution for injection/infusion contains less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium-free’.

4.6    Pregnancy and lactation

Addition of the sub-heading “Fertility”

4.8    Undesirable effects

Addition of the’ Not Known’ column in the table for undesirable effects.

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

 Correction of dates

10.       DATE OF REVISION OF THE TEXT

Updated on 12 April 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 20 April 2010

Reasons for updating

  • Change to improve clarity and readability

Updated on 19 April 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 April 2010

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

None provided