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

Opinion/decision on a Paediatric investigation plan (PIP): Voxzogo, vosoritide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000235382

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EMA 对 Voxzogo（vosoritide）已获批儿科研究计划（PIP）的修改申请作出决定，决定编号 EMA/PE/0000235382，决定日期 11/07/2025。该 PIP 针对先天性、家族性及遗传性疾病领域，适应症为软骨发育不全，剂型为注射用粉末，皮下给药，未进行合规检查。

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Key facts

Invented name: Voxzogo
Active substance: vosoritide
Therapeutic area: Congenital, familial and genetic disorders
Decision number: EMA/PE/0000235382
PIP number: EMA/PE/0000235382
Pharmaceutical form(s): Powder for solution for injection
Condition(s) / indication(s): Treatment of hypochondroplasia
Route(s) of administration: Subcutaneous use
Contact for public enquiries
Decision type: PM: decision on the application for modification of an agreed PIP
Decision date: 11/07/2025
Compliance check done: No

来源：EMA What's New · ema.europa.eu