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OVALEAP 900 UI/1,5 ML SOLUCION INYECTABLE - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/OVALEAP 900 UI/1,5 ML SOLUCION INYECTABLE

Approved

STANDARD

OVALEAP 900 UI/1,5 ML SOLUCION INYECTABLE

Theramex Ireland Limited🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Jun 23, 2025
Approval ID: fd80df40fa609530
Company: Theramex Ireland Limited
Type: Standard

Approval Details

Approval Id: fd80df40fa609530
Drug Cima Aemps Name: OVALEAP 900 UI/1,5 ML SOLUCION INYECTABLE
Register Number: 113871003IP
Holder Company Name: Theramex Ireland Limited
Marketing Company Name: Abacus Medicine A/S
Holder Company Detail Path: /organization/5cab369e350af10a/theramex-ireland-ltd
Authorization Date: 2025-06-23
Dosage Form: SOLUCIÓN PARA PERFUSIÓN
Dose: 600 IU/ml
Route Of Administration: VÍA SUBCUTÁNEA
Prescription Type: Diagnóstico Hospitalario
Commercialized: No
Company Name: Theramex Ireland Limited
Company Detail Path: /organization/5cab369e350af10a/theramex-ireland-ltd

Company Information

Pharmaceutical Company Name: Theramex Ireland Ltd.
Country Name: Ireland

Active Ingredients

FOLITROPINA ALFA

600 UI

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Jun 23, 2025

Approval ID

fd80df40fa609530

Type

Standard

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