Approvals/CIMA-AEMPS/DRONEDARONA AUROVITAS 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

Approved

STANDARD

DRONEDARONA AUROVITAS 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

Aurovitas Spain, S.A.U.🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Id: 8b28eca07113ecb7
Drug Cima Aemps Name: DRONEDARONA AUROVITAS 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Register Number: 85109
Holder Company Name: Aurovitas Spain, S.A.U.
Marketing Company Name: Aurovitas Spain, S.A.U.
Authorization Date: 2020-05-29
Dosage Form: COMPRIMIDO RECUBIERTO CON PELÍCULA
Dose: 400 mg
Route Of Administration: VÍA ORAL
Prescription Type: Diagnóstico Hospitalario
Commercialized: No
Company Name: Aurovitas Spain, S.A.U.

DRONEDARONA CLORHIDRATO

426,21 mg

Approved

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

May 29, 2020

Approval ID

8b28eca07113ecb7

Type

Standard