Hepatitis B
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EMA safety_alert · 2016-12-02PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
The EMA’s Pharmacovigilance Risk Assessment Committee warns that hepatitis B re-activation can occur in patients with past or current hepati…
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CLINICAL_TRIALS safety_alert · 2016-04-14Clinical Trial Update: Risk of Hepatitis B Reactivation After Bone Marrow Transplantation With Prior Hepatitis B Virus (HBV) Exposure
The trial update warns of the risk of hepatitis B reactivation in patients who have prior exposure to hepatitis B virus undergoing bone marr…
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CLINICAL_TRIALS safety_alert · 2014-02-06Clinical Trial Update: Hepatitis B Virus Reactivation After Withdrawal of Preemptive Antiviral Therapy in Hematologic Malignancy
The update reports hepatitis B virus reactivation after withdrawal of preemptive antiviral therapy in patients with hematologic malignancies…
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CLINICAL_TRIALS safety_alert · 2014-01-13Clinical Trial Update: Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine
This is a completed post-marketing safety study of GlaxoSmithKline's Pediarix vaccine, a DTaP-HepB-IPV combination, evaluating safety for He…
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EMA safety_alert · 2007-03-05Public statement: Baraclude (entecavir): Occurrence of a resistant HIV variant in a patient co-infected with HIV and HBV
EMA public statement about the occurrence of a resistant HIV variant in a patient co-infected with HIV and hepatitis B while on Baraclude (e…
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EMA safety_alert · 2006-05-08European Medicines Agency finds no signal for decreased effectiveness of HBVAXPRO and Procomvax
The EMA reports no evidence of decreased effectiveness for the hepatitis B vaccines HBVAXPRO and Procomvax following investigations.