Crysvita solution for subcutaneous injection
*Company:
Kyowa Kirin International plcStatus:
UpdatedLegal 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