DILANTIN PAEDIATRIC SUSPENSION phenytoin 30 mg/5 mL oral liquid bottle, Viatris Pty Ltd , CON-1202
Product name
DILANTIN PAEDIATRIC SUSPENSION phenytoin 30 mg/5 mL oral liquid bottle
Sponsor name
Viatris Pty Ltd
Consent start
Consent no.
CON-1202
Standard
European Pharmacopoeia (Ph. Eur.) general monograph 5.20 and British Pharmacopoeia (BP) general monograph SC IV Q for Elemental Impurities (i.e. adopted guideline of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D Impurities - Guideline on Elemental impurities) of European Pharmacopoeia
Non-compliance with standard
The product(s) exceed the ICH Q3D limits for Lead and Lithium for adults. The
request for consent to apply to all batches released for supply from 10 January
2024 until 31 December 2024 or until the current category 1 application is
approved, whichever occurs first.
Conditions imposed
1.The levels of lead and lithium present in the product must not exceed the
Permitted Daily Exposure limits for children.
2. The products are supplied with the Dear Healthcare Practitioner (DHCP) letter
provided to the Therapeutic Goods Administration via email on 8 January 2024.
Therapeutic product type
Prescription medicines