Sepiapterin

Sephience 1000 MG Polvo Oral en Sobre

1000 mg polvo oral en sobreSpainAuthorisedAuthorised 12 Jun 2026

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

SephienceEuropean UnionAuthorised

SephienceBrazil · PTC Farmaceutica do Brasil Ltda.Same brand
SephienceCanada · 1000 MG / SACHET · Powder · PTC Therapeutics International LimitedSame brand
SephienceCanada · 250 MG / SACHET · Powder · PTC Therapeutics International LimitedSame brand
SephienceEuropean Union · PTC Therapeutics International LimitedSame brand
SephienceCroatiaSame brand
Sephience 1.000 mg poeder voor oraal gebruik in sachetNetherlands · Poeder voor oraal gebruik · PTC Therapeutics International Limited

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Sepiapterin

Sephience 1000 MG Polvo Oral en Sobre

1000 mg polvo oral en sobreSpainAuthorisedAuthorised 12 Jun 2026

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

SephienceEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Sephience 250 mg poeder voor oraal gebruik in sachetNetherlands · Poeder voor oraal gebruik · PTC Therapeutics International Limited

SephienceUnited States · 1GM/PACKET, 250MG/PACKET · powder · PTC Therap

Packs

Pack	Code	Status
SEPHIENCE 1000 MG POLVO ORAL EN SOBRE, 30 sobres	770809

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Sepiapterin
Strength: 1000 mg
Dosage form: polvo oral en sobre
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 12 Jun 2026
Registration: 1251939002
Marketing authorisation holder: Ptc Therapeutics International Limited
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/25/1939