Upstaza
*Company:
PTC Therapeutics International LimitedStatus:
No Recent UpdateLegal 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 21 March 2024
File name
ema-combined-h-5352-en-11mar24-II 014G - SmPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to restricted prescription (C)
Updated on 21 March 2024
File name
ema-combined-h-5352-en-11mar24-II 014G - PIL.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 June 2023
File name
ema-combined-h-5352-en-08jun23-IB 012 - SmPC.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Shelf-life updated to 45 months
Updated on 12 April 2023
File name
ema-combined-h-5352-en-21mar23-IB 007G - SmPC.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Addition of ATC Code
Shelf-life of unopened frozen vials extended from 36 to 42 months
Updated on 06 December 2022
File name
ema-combined-h-5352-en-29sep22-IB 001G and N002 - SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Initial registration
Shelf-life extension IB/001/G
Updated on 06 December 2022
File name
ema-combined-h-5352-en-29sep22-IB 001G and N002 - PIL.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Initial registration
Addition of local contact information (N002)