Upstaza
*Company:
PTC Therapeutics International 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 01 May 2025
File name
Upstaza SmPC May 2025.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Addition on information on Dyskinesias, Immunogenicity, Floppiness (hypotonia) limb dystonia.
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)
PTC Therapeutics International Limited
Address:
Unit 1, 52-55 Sir John Rogerson's Quay, Dublin 2, D02 NA07, IrelandMedical Information E-mail:
medinfo@ptcbio.comTelephone:
+ 353 (0) 1 906 700Medical Information Direct Line:
+ 353 (0) 1906 8703