Dutasterida + Tansulosina Betude 0.5 mg + 0.4 mg Cápsula

Land: Portugal

Språk: portugisiska

Källa: INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

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Bipacksedel Bipacksedel (PIL)
23-08-2019
Produktens egenskaper Produktens egenskaper (SPC)
13-05-2024

Aktiva substanser:

Dutasterida + Tansulosina

Tillgänglig från:

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

ATC-kod:

G04CA52

INN (International namn):

Dutasteride + Tamsulosin

Dos:

0.5 mg + 0.4 mg

Läkemedelsform:

Cápsula

Sammansättning:

Dutasterida 0.5 mg ; Tansulosina, cloridrato 0.4 mg

Administreringssätt:

Via oral

Enheter i paketet:

Frasco 30 unidade(s)

Klass:

7.4.2.1 - Medicamentos usados na retenção urinária

Receptbelagda typ:

MSRM

Terapeutisk grupp:

Genérico

Terapiområde:

tamsulosin and dutasteride

Terapeutiska indikationer:

Duração do Tratamento: Longa Duração

Produktsammanfattning:

Número de Registo: 5779814 CNPEM: 50119281 CHNM: 10100248 Comercializado

Bemyndigande status:

Autorizado

Tillstånd datum:

2019-08-23

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