Crysvita solution for subcutaneous injection *

  • Company:

    Kyowa Kirin International plc
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *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 21 July 2021

File name

Burosumab sol for inj (Crysvita) SPC Ireland clean (002)_1626871954.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Major change is the introduction of the option of Self/ carer administration which is detailed in Section 4.2

Updated on 21 July 2021

File name

Burosumab sol for inj (Crysvita) PIL Ireland clean (002)_1626871524.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Change to dosage and administration

Free text change information supplied by the pharmaceutical company

Major change is the addition of the option of self/carer administration. As a result, there is a detailed Instructions for Use section added that wasnt previously included when the medicine was HCP administration only. 

Updated on 24 March 2021

File name

Burosumab sol for inj (Crysvita) SPC Ireland clean_1616572044.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 October 2020

File name

Burosumab sol for inj (Crysvita) SPC Ireland clean_1603625428.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 October 2020

File name

Burosumab sol for inj (Crysvita) PIL Ireland clean_1603625356.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 07 October 2020

File name

Burosumab sol for inj (Crysvita) SPC Ireland clean_1602056596.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 October 2020

File name

Burosumab sol for inj (Crysvita) PIL Ireland clean_1602056547.pdf

Reasons for updating

  • Change to section 1 - what the product is used for

Updated on 16 April 2020

File name

Burosumab sol for inj (Crysvita) SPC Ireland clean_1587030251.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 16 April 2020

File name

Burosumab sol for inj (Crysvita) PIL-Ireland clean revised_1587030198.pdf

Reasons for updating

  • New PIL for new product