ARTG Entry
NICABATE
ARTG entry for NICABATE (nicotine polacrilex), ARTG 258233 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Dr Reddys Laboratories
- Active ingredient: nicotine polacrilex
- Therapeutic area: Psychiatry
What it is
Nicabate is a nicotine-containing medicine available in multiple formulations: transdermal patches delivering 7 mg, 14 mg, or 21 mg over 24 hours; lozenges in 2 mg and 4 mg strengths; mini lozenges in 1.5 mg and 4 mg strengths; and chewing gum in 2 mg and 4 mg strengths.
Approved indications
The source documents do not specify the approved indications for Nicabate. Please consult the product information or ARTG records for full details of approved uses.
Dosing overview
The source documents do not contain detailed dosing information for Nicabate. Please consult the product information for dosing guidance.
Key safety warnings
The source documents do not contain information about key safety warnings for Nicabate. Please consult the product information or speak with a healthcare professional.
Contraindications
The source documents do not contain information about contraindications for Nicabate. Please consult the product information or speak with a healthcare professional.
PBS listing
Nicabate transdermal patch 114 mg is listed on the PBS as a single item with restricted access, with an ex-manufacturer price of A$35.23.
Regulatory history
Nicabate Clear Patch formulations (7 mg, 14 mg, and 21 mg per 24 hours) were first registered on the ARTG on 7 December 2001. Nicabate lozenges in 2 mg and 4 mg strengths were registered on 13 March 2002. Nicabate Mini Lozenges in 1.5 mg and 4 mg mint flavour formulations were registered on 10 November 2008. Nicabate P 21 mg per 24 hours transdermal patch was registered on 12 May 2010. Nicabate Gum in 2 mg and 4 mg mint flavour formulations were registered on 28 August 2015. Updated Mini Lozenges formulations in 2 mg and 4 mg strengths (as polacrilex) were registered on 11 July 2022.