PSUSA/00010190/201506 - periodic safety update report single assessment

Alanine / arginine / aspartic acid / cysteine / glucose anhydrous / glutamic acid / glycine / histidine / isoleucine / leucine / lysine / methionine / olive oil refined / ornithine / phenylalanine / proline / serine / sodium chloride / sodium glycerophosphate hydrated / soya bean oil / taurine / threonine / tryptophan / tyrosine / valine / potassium acetate / calcium chloride dihydrate / magnesium acetate tetrahydrate / olive oil

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:
  Alanine / arginine / aspartic acid / cysteine / glucose anhydrous / glutamic acid / glycine / histidine / isoleucine / leucine / lysine / methionine / olive oil refined / ornithine / phenylalanine / proline / serine / sodium chloride / sodium glycerophosphate hydrated / soya bean oil / taurine / threonine / tryptophan / tyrosine / valine / potassium acetate / calcium chloride dihydrate / magnesium acetate tetrahydrate / olive oil
• Procedure number:
  PSUSA/00010190/201506
• Regulatory outcome:
  Maintenance

Documents

Alanine / arginine / aspartic acid / cysteine / glucose anhydrous / glutamic acid / glycine / histidine / isoleucine / leucine / lysine / methionine / olive oil refined / ornithine / phenylalanine / proline / serine / so...

Reference Number: EMA/146018/2016