DILANTIN PAEDIATRIC SUSPENSION phenytoin 30mg/5mL oral liquid bottle, Upjohn Australia Pty Ltd , CON-625
Product name
DILANTIN PAEDIATRIC SUSPENSION phenytoin 30mg/5mL oral liquid bottle
Sponsor name
Upjohn Australia Pty Ltd
Consent start
Consent no.
CON-625
Standard
BP or USP general requirements for Elemental Impurities (= International Conference on Harmonisation (ICH) Q3D Guideline on Elemental Impurities).
Non-compliance with standard
levels of lithium and lead in excess of the ICH Q3D permitted daily exposure
limits when dosed to patients with higher body weights (e.g. adults).
Therapeutic product type
Prescription medicines