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CILICAINE VK phenoxymethylpenicillin (as potassium) 500mg capsule blister pack, Viatris Pty Ltd, CON-1314
Product name
CILICAINE VK phenoxymethylpenicillin (as potassium) 500mg capsule blister pack
Sponsor name
Viatris Pty Ltd
Batches
CVBBV0172; CVBBV0173; CVBBV0174; CVBBV0175
Consent start
Consent no.
CON-1314
Duration
The consent is effective from 28 February 2025 until 28 February 2027.
Standard
Subsection 8(j) and Schedule 1 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product labels do not declare the presence or quantity of potassium in the
medicine, even though it exceeds 39mg per maximum recommended daily dose. The
medicine contain 335-338mg per maximum daily dose.
Conditions imposed
The labels will be updated to include the omitted information as soon as
possible.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines