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TAKHZYRO 300 mg solution for injection in vial

  • Name:

    TAKHZYRO 300 mg solution for injection in vial

  • Company:
    info
  • Active Ingredients:

    Lanadelumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/05/20

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Summary of Product Characteristics last updated on medicines.ie: 4/1/2021
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

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Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
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Medicine Name Mezavant XL Active Ingredients Mesalazine
Medicine Name Plenadren 5 mg and 20 mg modified release tablets Active Ingredients Hydrocortisone
Medicine Name Reminyl Oral Solution Active Ingredients Galantamine Hydrobromide
Medicine Name Reminyl XL 8mg, 16mg and 24 mg prolonged release capsules Active Ingredients Galantamine Hydrobromide
Medicine Name Resolor 1 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Resolor 2 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name TAKHZYRO 300 mg solution for injection in pre-filled syringe Active Ingredients Lanadelumab
Medicine Name TAKHZYRO 300 mg solution for injection in vial Active Ingredients Lanadelumab
Medicine Name Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
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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 4 January 2021 SPC

Reasons for updating

  • Change from joint to individual SPCs

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

Updated on 6 August 2020 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

From 30 months to 2 years (vial presentation)

Updated on 21 May 2020 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

  1.  

Updated on 21 May 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 9 August 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 9 August 2019 SPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

Updates to sections 6.5 additional pack sizes and section 8 additional procedure numbers

Updated on 7 January 2019 PIL

Reasons for updating

  • New PIL for new product