Casgevy 4 - 13 x 10Exp6 cells/mL dispersion for infusion
*Company:
Vertex Pharmaceuticals (Ireland) LimitedStatus:
UpdatedLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 09 September 2025
File name
Casgevy SmPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- 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 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- Updates to Section 4.4, Gene-editing related oncogenesis: updated to say off target editing was observed based on study U270
- Section 5.3, Preclinical safety data: updated to include findings from study U270
- Minor administrative/editorial changes were made to sections 2.2, 4.8 and 5.1 and 9
Updated on 29 October 2024
File name
Casgevy EU Ireland PIL September 2024.pdf
Reasons for updating
- Addition of manufacturer
Free text change information supplied by the pharmaceutical company
Addition of Lonza manufacturer
Updated on 29 October 2024
File name
Casgevy EU Ireland SPC September 2024.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to restricted prescription (C)
Updated on 05 April 2024
File name
Casgevy EU Ireland SPC March 2024.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to restricted prescription (C)
Updated on 05 April 2024
File name
Casgevy EU Ireland PIL March 2024.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 02 April 2024
File name
Casgevy EU Ireland SPC MAA 9Feb2024.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Vertex Pharmaceuticals (Ireland) Limited
 Limited.webp)
Address:
Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, IrelandMedical Information E-mail:
vertexmedicalinfo@vrtx.comTelephone:
+353 (1) 7617299Fax:
+44 (0)20 3204 5220Medical Information Facsimile:
+44 (0)1235 438 190Medical Information Direct Line:
1800 924568Customer Care direct line:
1800924568