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OMLYCLO 75 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/OMLYCLO 75 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA

Approved

STANDARD

OMLYCLO 75 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA

Celltrion Healthcare Hungary Kft.🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Jun 26, 2025
Approval ID: 109d62a9b2feb869
Company: Celltrion Healthcare Hungary Kft.
Type: Standard

Approval Details

Approval Id: 109d62a9b2feb869
Drug Cima Aemps Name: OMLYCLO 75 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA
Register Number: 1241817005
Holder Company Name: Celltrion Healthcare Hungary Kft.
Marketing Company Name: Celltrion Farmacéutica (España) S.L.
Holder Company Detail Path: /organization/518802646099655f/celltrion-healthcare-hungary-kft
Authorization Date: 2025-06-26
Dosage Form: SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Dose: 75 mg
Route Of Administration: VÍA SUBCUTÁNEA
Prescription Type: Diagnóstico Hospitalario
Commercialized: No
Company Name: Celltrion Healthcare Hungary Kft.
Company Detail Path: /organization/518802646099655f/celltrion-healthcare-hungary-kft

Company Information

Pharmaceutical Company Name: Celltrion Healthcare Hungary Kft
Country Name: Hungary

Active Ingredients

OMALIZUMAB

75 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Jun 26, 2025

Approval ID

109d62a9b2feb869

Type

Standard

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