Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Roflumilast
Strength: 0,5 mg
Dosage form: comprimido
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 27 Oct 2020
Registration: 85529
Marketing authorisation holder: Aurovitas Spain, S.A.U.
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica

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Roflumilast Accord 500 Microgramos Comprimidos Recubiertos con Pelicula EfgRoflumilast · 0,5 mg · comprimido recubierto con películaSpainWithdrawn

Roflumilast Ferrer 250 Microgramos Comprimidos EfgRoflumilast · 0,25 mg · comprimidoSpainWithdrawn

Roflumilast Ferrer 500 Microgramos Comprimidos EfgRoflumilast · 0,5 mg · comprimidoSpainWithdrawn