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Hemlibra · 4.8 · Immunogenicity
Eintrag öffnenHemlibra · 4.8 · In pooled phase III clinical studies, TMA events were reported in less than 1 % of patients (3/444) and in 9.7
Eintrag öffnenHemlibra · 4.8 · In pooled phase III clinical studies, serious thrombotic events were reported in less than 1 % of patients (2/
Eintrag öffnenHemlibra · 4.8 · In the pooled phase III clinical studies with Hemlibra, development of neutralising anti-emicizumab antibodies
Eintrag öffnenHemlibra · 4.8 · In total three patients (0.7 %) in the clinical studies receiving Hemlibra prophylaxis withdrew from treatment
Eintrag öffnenHemlibra · 4.8 · Injection site reactions
Eintrag öffnenHemlibra · 4.8 · Injection site reactions (ISRs) were reported very commonly (19.4 %) from the pooled phase III clinical studie
Eintrag öffnenHemlibra · 4.8 · Paediatric population
Eintrag öffnenHemlibra · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenHemlibra · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenHemlibra · 4.8 · Summary of the safety profile
Eintrag öffnenHemlibra · 4.8 · System Organ Class (SOC) Adverse reactions Frequency (preferred term, MedDRA)
Eintrag öffnenHemlibra · 4.8 · Table 3 Characterisation of aPCC treatment* in the pooled phase III clinical studies
Eintrag öffnenHemlibra · 4.8 · Tabulated list of adverse drug reactions
Eintrag öffnenHemlibra · 4.8 · The following adverse drug reactions (ADRs) are based on data from post-marketing surveillance and pooled data
Eintrag öffnenHemlibra · 4.8 · The most common ADRs reported in ≥ 10% of patients treated with at least one dose of Hemlibra were: injection
Eintrag öffnenHemlibra · 4.8 · The overall safety profile of Hemlibra is based on data from clinical studies and post-marketing surveillance.
Eintrag öffnenHemlibra · 4.8 · The paediatric population studied comprises a total of 137 patients, of which 5 (3.6 %) were infants and toddl
Eintrag öffnenHemlibra · 4.8 · There were 82 instances of aPCC treatment* in patients receiving Hemlibra prophylaxis, of which eight instance
Eintrag öffnenHemlibra · 4.8 · Thrombotic events
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