Deliberação n.º 1068/2006, de 26 de Julho de 2006
Deliberaçáo n.o 1068/2006
A empresa Sankyo Pharma Portugal - Comércio de Produtos Farmacêuticos, L.da, é titular da autorizaçáo de introduçáo no mercado (AIM) dos medicamentos Claudemor, associaçáo, supositórios e Claudemor, associaçáo, pomada rectal, consubstanciada na autorizaçáo com os registos n.os 9947705 e 9947606, respectivamente, concedidas em 24 de Fevereiro de 1989.
Na sequência da avaliaçáo do processo de renovaçáo do medicamento supracitado, o INFARMED efectuou um pedido de elementos de acordo com o parecer do perito clínico, ao qual o titular náo respondeu.
Nos termos e para os efeitos previstos nos artigos 100.o e 101.o do Código do Procedimento Administrativo, foi promovida a audiência prévia e escrita dos interessados, náo tendo nesta sede o titular do AIM apresentado fundamentaçáo para os motivos de indeferimento.
Assim, nos termos das disposiçóes do artigo 11.o, n.o 1, alínea a), do Decreto-Lei n.o 72/91, de 8 de Fevereiro, com a redacçáo introduzida pelo Decreto-Lei n.o 272/95, de 23 de Outubro, e ao abrigo do despacho n.o 16 790/2005 (2.a série), do Secretário de Estado da Saúde, publicado no Agosto de 2005, o conselho de administraçáo do INFARMED...
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