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DARZALEX 1.800 MG SOLUCION INYECTABLE - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/DARZALEX 1.800 MG SOLUCION INYECTABLE

Approved

STANDARD

DARZALEX 1.800 MG SOLUCION INYECTABLE

Janssen-Cilag International N.V🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Jun 17, 2025
Approval ID: 0dff19dbf6572e5c
Company: Janssen-Cilag International N.V
Type: Standard

Approval Details

Approval Id: 0dff19dbf6572e5c
Drug Cima Aemps Name: DARZALEX 1.800 MG SOLUCION INYECTABLE
Register Number: 1161101004IP1
Holder Company Name: Janssen-Cilag International N.V
Marketing Company Name: Ecofar Productos S.L.
Holder Company Detail Path: /organization/01c9e6e3ee1a82cf/janssen-cilag-international-nv
Authorization Date: 2025-06-17
Dosage Form: SOLUCIÓN INYECTABLE
Dose: 1800 mg
Route Of Administration: VÍA SUBCUTÁNEA
Prescription Type: Uso Hospitalario
Commercialized: No
Company Name: Janssen-Cilag International N.V
Company Detail Path: /organization/01c9e6e3ee1a82cf/janssen-cilag-international-nv

Company Information

Pharmaceutical Company Name: Janssen-Cilag International NV
Country Name: Belgium

Active Ingredients

DARATUMUMAB

1800 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Jun 17, 2025

Approval ID

0dff19dbf6572e5c

Type

Standard

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