PSUSA/00002786/202103 - periodic safety update report single assessment

Bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes, streptococcus pneumoniae / streptococcus aga

About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

• Active substance(s) in scope of the PSUSA procedure:
  Bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes, streptococcus pneumoniae / streptococcus aga
• Procedure number:
  PSUSA/00002786/202103
• Regulatory outcome:
  Maintenance

Documents

Bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / strep. pneumoniae / strep. pyogenes : List of nationally authorised medicinal products - PSUSA/00002786/202103

Reference Number: EMA/689851/2021