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XBRYK 120 MG SOLUCION INYECTABLE - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/XBRYK 120 MG SOLUCION INYECTABLE

Approved

STANDARD

XBRYK 120 MG SOLUCION INYECTABLE

Samsung Bioepis Nl B.V.🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Jun 19, 2025
Approval ID: a8cd6accd0ccdddb
Company: Samsung Bioepis Nl B.V.
Type: Standard

Approval Details

Approval Id: a8cd6accd0ccdddb
Drug Cima Aemps Name: XBRYK 120 MG SOLUCION INYECTABLE
Register Number: 1241889001
Holder Company Name: Samsung Bioepis Nl B.V.
Marketing Company Name: Samsung Bioepis Nl B.V.
Holder Company Detail Path: /organization/samsung-bioepis-nl-b-v
Marketing Company Detail Path: /organization/samsung-bioepis-nl-b-v
Authorization Date: 2025-06-19
Dosage Form: SOLUCIÓN INYECTABLE
Dose: 120 mg
Route Of Administration: VÍA SUBCUTÁNEA
Prescription Type: Diagnóstico Hospitalario
Commercialized: Yes
Company Name: Samsung Bioepis Nl B.V.
Company Detail Path: /organization/samsung-bioepis-nl-b-v

Company Information

Pharmaceutical Company Name: Samsung Bioepis NL B.V.
Country Name: Netherlands

Active Ingredients

DENOSUMAB

120 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Jun 19, 2025

Approval ID

a8cd6accd0ccdddb

Type

Standard

Back to CIMA-AEMPS Approvals