EMA 就 Vafseo（vadadustat）儿科研究计划修改申请作出决定

Opinion/decision on a Paediatric investigation plan (PIP): Vafseo, vadadustat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: EMA/PE/0000245403

AI 导读

EMA 对 Vafseo（vadadustat）已同意儿科研究计划的修改申请作出决定，决定编号 EMA/PE/0000245403，决定日期 2025 年 7 月 11 日。Vafseo 为口服薄膜衣片，拟用于慢性疾病所致贫血，申请方为 Medice Arzneimittel Puetter GmbH & Co. KG。

正文 · 原文

Key facts

Invented name

Vafseo

Active substance

vadadustat

Therapeutic area

Blood and lymphatic system disorders

Decision number

EMA/PE/0000245403

PIP number

EMA/PE/0000245403

Pharmaceutical form(s)

Film-coated tablet
Age appropriate oral formulation

Condition(s) / indication(s)

Treatment of anaemia due to chronic disorders

Route(s) of administration

Oral use

Contact for public enquiries

Medice Arzneimittel Puetter GmbH & Co. KG
E-mail: info@medice.de
Tel. +49 23719370

Decision type

PM: decision on the application for modification of an agreed PIP

Decision date

11/07/2025

Compliance check done

来源：EMA What's New · ema.europa.eu