Crysvita solution for subcutaneous injection

*
Pharmacy Only: Prescription
  • Company:

    Kyowa Kirin International plc
  • Status:

    No Recent Update
  • Legal Category:

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

    *Additional information is available within the SPC or upon request to the company

Updated on 12 April 2024

File name

PIL - English Ireland- Pre-filled syringe.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 April 2024

File name

PIL - English Ireland- solution for injection.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 22 February 2024

File name

PIL - English UK-NI IE.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Addition of joint PIL covering all presentations

Free text change information supplied by the pharmaceutical company

Introduction of Pre-filled Syringe for all product presentations.

Updated on 22 February 2024

File name

PIL - English UK-NI IE.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Addition of joint PIL covering all presentations

Free text change information supplied by the pharmaceutical company

Introduction of Pre-filled Syringe for all product presentations.

Updated on 22 February 2024

File name

crysvita-local-spc-ireland-northern ireland-en.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.3 - Shelf life
  • 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 8 - Marketing authorisation number(s)
  • Change from individual to joint SPC

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

Updated on 22 February 2024

File name

crysvita-local-spc-ireland-northern ireland-en.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.3 - Shelf life
  • 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 8 - Marketing authorisation number(s)
  • Change from individual to joint SPC

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

Updated on 24 July 2023

File name

PIL - English and French - UK-NI IE.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 22 July 2023

File name

CRYSVITA Ireland Northern Ireland - SPC June 2023 Black Triangle Removal.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

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

Updated on 07 October 2022

File name

Burosumab sol for inj (Crysvita) SPC Ireland Oct 22_pa_clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Other

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

Free text change information supplied by the pharmaceutical company

Note that this medicines marketing authorisation has been converted from conditional to standard as part of this update.

Updated on 07 October 2022

File name

Burosumab sol for inj (Crysvita) PIL Ireland Oct 22_pa_clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Free text change information supplied by the pharmaceutical company

Note that the following statement has also been removed from the PIL following conversion from conditional to standard marketing authorisation: "This medicine has been given "conditional approval". This means that there is more evidence to come about this medicine."

Updated on 07 September 2022

File name

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

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to other sources of information section

Updated on 07 September 2022

File name

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

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 08 February 2022

File name

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

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

Update to Section 9 "Date of Renewal of the Authorisation" From 21st February 2021 to 21st February 2022

Update to Section 10 "Date of revision of the text" from 05/2021 to 01/2022

Updated on 23 December 2021

File name

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

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 July 2021

File name

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

Reasons for updating

  • New PIL for new product