Sephience
*Company:
PTC Therapeutics International LimitedStatus:
NewLegal 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 July 2025
File name
ema-combined-h-6331-en-printready-19Jun2025-MA-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
Summary of Product Characteristics for new product Sephience (Sepiapterin).
Updated on 01 July 2025
File name
ema-combined-h-6331-en-printready-19Jun2025-MA-PIL (1).pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New patient information leaflet for new product.
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