Guidelines & Codes
Update to Section 13.2.2 Preparing a Data Sheet for
Approval - Content
[NZRGM, Volume 1, 5th edition]
Added to web site: September 2003
Dosing guidelines
Tablets:
If a tablet is not intended to be divided, or has not been proven to be capable of providing a divided dose, then the "Presentation" and "Dosage & Administration" sections of the tablet's data sheet should contain the following statement: "Do not halve tablet".
Dosing regimens:
A proposed product, or product range should be capable of delivering all doses associated with the proposed indications (e.g. a 20mg capsule, or non-divisible tablet is not capable of delivering a starting dose of 10mg per day). Where the proposed product range is not capable of delivering all doses associated with the approved indications, then both the "Presentation" and "Dosage and Administration" sections of the product's datasheet should include the following statement: "This product is not able to deliver all approved dose regimens".