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Xtandi 40 mg film-coated tablets

  • Name:

    Xtandi 40 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    enzalutamide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/05/21

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Summary of Product Characteristics last updated on medicines.ie: 5/5/2021

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Astellas Pharma Co. Ltd

Astellas Pharma Co

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Medicine Name Eligard 45mg Active Ingredients Leuprorelin Acetate
Medicine Name Eligard 7.5mg Active Ingredients Leuprorelin Acetate
Medicine Name Modigraf 0.2mg & 1mg granules for oral suspension Active Ingredients Tacrolimus Monohydrate
Medicine Name Omnexel Active Ingredients Tamsulosin Hydrochloride
Medicine Name Prograf Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf Concentrate for Infusion Active Ingredients Tacrolimus
Medicine Name Vesitirim 1 mg/ml oral suspension Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 10mg Film-coated Tablets Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 5mg Film-Coated tablets Active Ingredients Solifenacin succinate
Medicine Name Vesomni 6 mg/0.4 mg modified release tablets Active Ingredients Solifenacin succinate, Tamsulosin Hydrochloride
Medicine Name Xospata 40 mg film-coated tablets Active Ingredients Gilteritinib
Medicine Name Xtandi 40 mg film-coated tablets Active Ingredients enzalutamide
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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 5 May 2021 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 5 May 2021 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 22 April 2021 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 22 April 2021 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 25 February 2021 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 February 2021 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 18 February 2020 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 18 February 2020 PIL

Reasons for updating

  • New PIL for new product