Acetato de eslicarbazepina Pharmakern 800 mg Comprimido

Nchi: Ureno

Lugha: Kireno

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

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
15-01-2020
Tabia za bidhaa Tabia za bidhaa (SPC)
01-05-2024

Viambatanisho vya kazi:

Acetato de eslicarbazepina

Inapatikana kutoka:

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

ATC kanuni:

N03AF04

INN (Jina la Kimataifa):

Acetate eslicarbazepina

Kipimo:

800 mg

Dawa fomu:

Comprimido

Tungo:

Acetato de eslicarbazepina 800 mg

Njia ya uendeshaji:

Via oral

Vitengo katika mfuko:

Blister 20 unidade(s)

Darasa:

2.6 - Antiepilépticos e anticonvulsivantes

Dawa ya aina:

MSRM

Kundi la matibabu:

Genérico

Eneo la matibabu:

eslicarbazepine

Matibabu dalili:

Duração do Tratamento: Longa Duração

Bidhaa muhtasari:

Número de Registo: 5788708 CNPEM: 50117254 CHNM: 10097542 Não Comercializado

Idhini hali ya:

Autorizado

Idhini ya tarehe:

2020-01-15

Taarifa za kipeperushi

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