« Back to Medicines list

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

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 14/5/2019

Click on this link to Download PDF directly

Sanofi Genzyme

Sanofi Genzyme logo_1556886599

Company Products

Medicine NameActive Ingredients
Medicine Name Aldurazyme 100 U/ml concentrate for solution for infusion Active Ingredients Laronidase
Medicine Name AUBAGIO 14 mg film-coated tablets Active Ingredients Teriflunomide
Medicine Name Caprelsa 100mg and 300mg film coated tablets Active Ingredients Vandetanib
Medicine Name Cerdelga 84 mg capsules, hard Active Ingredients Eliglustat tartrate
Medicine Name Cerezyme 400 U Powder for concentrate for solution for infusion Active Ingredients Imiglucerase
Medicine Name Cholestagel 625mg film coated Tablets Active Ingredients Colesevelam hydrochloride
Medicine Name Dupixent 200 mg solution for injection in pre-filled pen Active Ingredients Dupilumab
Medicine Name Dupixent 200 mg solution for injection in pre-filled syringe Active Ingredients Dupilumab
Medicine Name Dupixent 300 mg solution for injection in pre-filled pen Active Ingredients Dupilumab
Medicine Name Dupixent 300mg solution for injection in pre-filled syringe Active Ingredients Dupilumab
Medicine Name Evoltra 1 mg/ml concentrate for solution for infusion Active Ingredients Clofarabine
Medicine Name Fabrazyme 35 mg, powder for concentrate for solution for infusion Active Ingredients Agalsidase beta
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
Medicine Name LEMTRADA 12 mg concentrate for solution for infusion Active Ingredients Alemtuzumab
Medicine Name Mozobil 20 mg ml solution for injection Active Ingredients Plerixafor
Medicine Name Myozyme 50 mg, powder for concentrate for solution for infusion. Active Ingredients Alglucosidase alfa
Medicine Name Thymoglobuline 25 mg powder for solution for infusion Active Ingredients Rabbit Anti-Human Thymocyte Immunoglobulin
Medicine Name Thyrogen 0.9 mg powder for solution for injection Active Ingredients Thyrotropin alfa
1 - 0 of 21 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 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