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4.5 a post-authorisation safety study (pass) is a scientific study aimed at drug safety.
4.5 Študija o varnosti zdravila po pridobitvi dovoljenja za promet (post-authorisation safety study – pass) je znanstvena študija, ki je namenjena zagotavljanju varnosti zdravil.
anx 2.1 - the mah commits to conduct a long-term comparative observational safety study.
dodatek 2.1 - imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel primerjalno opazovalno študijo dolgoročne varnosti.
multiple-cycle safety study in patients receiving either highly emetogenic chemotherapy or moderately emetogenic chemotherapy
Študija varnosti več ciklov pri bolnikih, ki so prejemali zelo emetogeno kemoterapijo ali zmerno emetogeno kemoterapijo