Fludara oral 10 mg film-coated tablets

  • Name:

    Fludara oral 10 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Fludarabine Phosphate

  • 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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Summary of Product Characteristics last updated on medicines.ie: 14/5/2019

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Sanofi Genzyme

Sanofi Genzyme logo_1556886599

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Medicine Name Fabrazyme 5 mg, powder for concentrate for solution for infusion Active Ingredients Agalsidase beta
Medicine Name Fasturtec Active Ingredients Rasburicase
Medicine Name Fludara 50 mg powder for solution for injection or infusion Active Ingredients Fludarabine Phosphate
Medicine Name Fludara oral 10 mg film-coated tablets Active Ingredients Fludarabine Phosphate
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1 - 0 of 17 items.Total: Infinity pages

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 SmPC

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 SmPC

Reasons for updating

  • Previous version of SmPC 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 SmPC

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 SmPC

Reasons for updating

  • New SmPC 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