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DILANTIN PAEDIATRIC SUSPENSION phenytoin 30mg/5mL oral liquid bottle, Viatris Pty Ltd, CON-1287
Product name
DILANTIN PAEDIATRIC SUSPENSION phenytoin 30mg/5mL oral liquid bottle
Sponsor name
Viatris Pty Ltd
Consent start
Consent no.
CON-1287
Duration
The consent is effective from 28 October 2024 until 31 October 2026.
Standard
General monograph 5.20 of European Pharmacopoeia
Non-compliance with standard
The product exceeds the limits set for Lead and Lithium for adults in the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) Q3D Impurities - Guideline on Elemental
impurities. This guideline is a guideline adopted under the European
Pharmacopoeia (Ph. Eur.) general monograph 5.20 and British Pharmacopoeia (BP)
general monograph SC IV Q for Elemental Impurities.
Conditions imposed
The levels of lead and lithium present in the product must not exceed the
Permitted Daily Exposure limits for children.
The products are supplied with the Dear Healthcare Practitioner (DHCP) letter.
If a new adult product is approved and ready for market prior to the expiration
of this consent, it will be supplied to adult patients in preference to this
paediatric preparation.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines