Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Plegridy

Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-130108 · Präparat HOS-096849

Tabulated list of adverse reactions via subcutaneous route of administration In clinical studies, a total of 1,468 patients received peginterferon beta-1a SC for up to 278 weeks with an overall exposure equivalent of 4,217 person -years. 1,285 patients received at least 1 year, 1,124 patients have received at least 2 years, 947 patients received at least 3 years, and 658 patients received at least 4 years of treatment with peginterferon beta-1a. The experience in the randomised, uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of the ADVANCE study.

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