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points to consider on the calculation and reporting of the prevalence of a condition for orphan designation
points to consider on the calculation and reporting of the prevalence of a condition for orphan designation
points to consider on pharmaco- kinetics and pharmacodynamics in the development of anti- bacterial medicinal products
and pharmacodynamics in the development of anti- bacterial medicinal products points to consider on switching between
points to consider on clinical investigation of medicinal products for the treatment of acute stroke
points to consider on clinical investigation of medicinal products for the treatment of acute stroke
kommissionen har besluttet ikke at foreslå en udvidelse af rammerne for fjernsynsdirektivet til nye point-to-point tjenester.
a comissão decidiu não propor o alargamento do âmbito da directiva «televisão» aos novos serviços ponto-a-ponto.
points to consider on good agricultural and collection practice for starting materials of herbal origin (*)
points to consider on good agricultural and collection practice for starting materials of herbal origin (*) proposal for a core- data for plantaginis psyllium
points to consider document on the non- clinical assessment of the carcinogenic potential of insulin analogues
points to consider document on the non- clinical assessment of the carcinogenic potential of insulin analogues
concept paper on the development of a cpmp points to consider on the need for reproduction toxicity studies in the development of human insulin analogues
reproduction toxicity studies in the development of human insulin analogues
concept paper on the development of a cpmp points to consider on methodological issues in confirmatory clinical trials with flexible design and analysis plan.
concept paper on the development of a cpmp points to consider on methodological issues in confirmatory clinical trials with flexible design and analysis plan.
concept paper on the development of a cpmp points to consider document on the evaluation of new anti- fungal agents for invasive fungal infections
concept paper on the development of a cpmp points to consider document on the evaluation of new anti- fungal agents for invasive fungal infections
points to consider on missing data points to consider on multiplicity issues in clinical trials
points to consider on multiplicity issues in clinical trials
points to consider concerning endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells
factors for mobilisation of autologous stem cells points to consider on the clinical investigation of new medicinal products for
need for post- marketing data contribution to cpmp points to consider document on xenogeneic cell therapy proposals for revision to standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
need for post- marketing data contribution to cpmp points to consider document on xenogeneic cell therapy proposals for revision to standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
concept paper on the development of a cpmp points to consider on allergic rhino- conjuctivitis.
concept paper on the development of a cpmp points to consider on allergic rhino- conjuctivitis.
points to consider on biostatistical/ methodological issues arising from cpmp discussion on licensing applications:
points to consider on biostatistical/ methodological issues arising from cpmp discussion on licensing applications:
adjustment for multiplicity and related topics points to consider on biostatistical/ methodological issues arising from cpmp discussion on licensing applications:
adjustment for multiplicity and related topics points to consider on biostatistical/ methodological issues arising from cpmp discussion on licensing applications:
3) indehaveren af markedsføringstilladelsen anmodes om at forelægge oplysninger om produktets kliniske værdi til den ansøgte indikation (direkte eller indirekte) i overensstemmelse med "points to consider on the evaluation of diagnostic agents" (cpmp/ ewp/ 1119/ 98).
3) pede- se ao titular da aim que forneça informações sobre a utilidade clínica deste produto para a indicação requerida (directa ou indirectamente), em conformidade com o documento “ pontos a considerar na avaliação de agentes de diagnóstico ” (cpmp/ ewp/ 1119/ 98).