Approvals/CIMA-AEMPS/ROCTAVIAN 2 × 10E13 GENOMAS DE VECTOR/ML SOLUCION PARA PERFUSION

Approved

STANDARD

ROCTAVIAN 2 × 10E13 GENOMAS DE VECTOR/ML SOLUCION PARA PERFUSION

Biomarin International Limited🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Id: 97a9e39fe7a2c78b
Drug Cima Aemps Name: ROCTAVIAN 2 × 10E13 GENOMAS DE VECTOR/ML SOLUCION PARA PERFUSION
Register Number: 1221668001
Holder Company Name: Biomarin International Limited
Marketing Company Name: Biomarin Pharmaceuticals España S.L.
Holder Company Detail Path: /organization/biomarin-international-limited
Authorization Date: 2023-02-03
Dosage Form: SOLUCIÓN PARA PERFUSIÓN
Dose: 2 × 10E13 VG/ML
Route Of Administration: VÍA INTRAVENOSA
Prescription Type: Uso Hospitalario
Commercialized: No
Company Name: Biomarin International Limited
Company Detail Path: /organization/biomarin-international-limited

VALOCTOCOGEN ROXAPARVOVEC

2x10E13 vg/ml

Approved

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Feb 3, 2023

Approval ID

97a9e39fe7a2c78b

Type

Standard