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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/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/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
Back to CIMA-AEMPS Approvals