Sephience

*
Pharmacy Only: Prescription
  • Company:

    PTC Therapeutics International Limited
  • Status:

    New
  • Legal 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

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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

PTC Therapeutics International Limited