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EPCLUSA 400 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/EPCLUSA 400 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA

Approved

STANDARD

EPCLUSA 400 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA

Gilead Sciences Ireland Unlimited Company🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Apr 14, 2025
Approval ID: 38f447f2a1ac4bdd
Company: Gilead Sciences Ireland Unlimited Company
Type: Standard

Approval Details

Approval Id: 38f447f2a1ac4bdd
Drug Cima Aemps Name: EPCLUSA 400 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Register Number: 1161116001IP
Holder Company Name: Gilead Sciences Ireland Unlimited Company
Marketing Company Name: Abacus Medicine A/S
Holder Company Detail Path: /organization/b73ba59d7c786555/gilead-sciences-ireland-unlimited-company
Authorization Date: 2025-04-14
Dosage Form: COMPRIMIDO RECUBIERTO CON PELÍCULA
Dose: 400 mg/100 mg
Route Of Administration: VÍA ORAL
Prescription Type: Diagnóstico Hospitalario
Commercialized: Yes
Company Name: Gilead Sciences Ireland Unlimited Company
Company Detail Path: /organization/b73ba59d7c786555/gilead-sciences-ireland-unlimited-company

Company Information

Pharmaceutical Company Name: GILEAD SCIENCES IRELAND UNLIMITED COMPANY
Country Name: Ireland
City Name: carrigtwohill,country_ie
Address: Ida Business & Technology Park

Active Ingredients

SOFOSBUVIR

400 mg

VELPATASVIR

100 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Apr 14, 2025

Approval ID

38f447f2a1ac4bdd

Type

Standard

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