Major variation 576 views0 applications

Definition: For therapeutic goods of a particular kind, means a change to: (a) The strength, as recorded in the entry in the Register; or _ (b) The dosage, the recommended dose regimen or the maximum daily dose; or _ (c) The dosage form; or _ (d) The route of administration; or _ (e) The intended patient group. _

As per: TGA

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