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DARZALEX 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION - CIMA-AEMPS Drug Approval Details
Approvals
/
CIMA-AEMPS
/
DARZALEX 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION
Approved
STANDARD
DARZALEX 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION
Janssen-Cilag International N.V
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Sep 16, 2025
Approval ID
57f8d1114acd29a2
Company
Janssen-Cilag International N.V
Type
Standard
Approval Details
Approval Id
57f8d1114acd29a2
Drug Cima Aemps Name
DARZALEX 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION
Register Number
1161101002IP1
Holder Company Name
Janssen-Cilag International N.V
Marketing Company Name
Orifarm A/S
Holder Company Detail Path
/organization/janssen-cilag-international-nv
Authorization Date
2025-09-16
Dosage Form
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Dose
20 mg/ml
Route Of Administration
VÍA INTRAVENOSA
Prescription Type
Uso Hospitalario
Commercialized
No
Company Name
Janssen-Cilag International N.V
Company Detail Path
/organization/janssen-cilag-international-nv
Company Information
Pharmaceutical Company Name
Janssen-Cilag International NV
Country Name
Belgium
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Sep 16, 2025
Approval ID
57f8d1114acd29a2
Type
Standard
Back to CIMA-AEMPS Approvals