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Ebvallo · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenEbvallo · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenEbvallo · 4.8 · Summary of the safety profile
Eintrag öffnenEbvallo · 4.8 · Table 2: Adverse reactions identified with Ebvallo System organ class (SOC) Adverse reaction Frequency Infecti
Eintrag öffnenEbvallo · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenEbvallo · 4.8 · The most common adverse reactions were pyrexia (31.1%), diarrhoea (26.2%), fatigue (23.3%), nausea (18.4%), an
Eintrag öffnenEbvallo · 4.8 · The safety database is comprised of data from 340 patients (EBV+ PTLD and other EBV-associated diseases) from
Eintrag öffnenEbvallo · 4.8 · There are limited data in paediatric patients (see section 5.1). Eight patients were ≥ 2 to < 6 years of age,
Eintrag öffnenEbvallo · 4.8 · There is potential for immunogenicity with Ebvallo. There is currently no information indicating that potentia
Eintrag öffnenEbvallo · 4.8 · Tumour flare reaction (TFR) TFR was reported in 1 patient (1%). The event was Grade 3 and the patient recovere
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