Stop smoking aids

A generic version of varenicline has been available in the UK since autumn 2024 which:

• is nitrosamine-compliant
• remains on the British National Formulary
• has an identical Summary of Product Characteristics as Champix

First marketed in the UK by Pfizer in 2006, varenicline (Champix) was an important stop smoking aid until 2021 when it was withdrawn after it was found to contain nitrosamines above the acceptable level. A nitrosamine-compliant Champix is being re-introduced to the UK in the summer of 2025
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This information is provided by Pfizer Ltd.

I am writing to give you advance notice that Champix (varenicline tartrate) will be re-introduced into the UK market in late June or early July of this year.

As you may recall, in 2021, Pfizer paused the distribution of Champix worldwide out of an abundance of caution following an evaluation that identified Champix contained levels of N-nitroso-varenicline above an acceptable intake (AI) limit set by regulatory authorities.

Since then, regulatory authorities have updated guidance on AI limits for N-nitroso-varenicline. Pfizer conducted rigorous and comprehensive testing that has confirmed that Champix meets all regulatory requirements set by regulatory agencies.

With this update to the acceptable intake (AI), coupled with Pfizer’s actions to lower the levels of N-nitroso-varenicline observed in Champix, Pfizer will re-introduce supply in the U.K.

PP-CHM-GBR-3813
D.o.P June 2025
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This section of the website contains resources for varenicline, which we use to describe both generic varenicline and Champix.

Nicotine vapes and the behaviour change techniques associated with them are covered in our online training and assessment programme, specifically the Vaping: a guide for healthcare professionals module.

This section includes a number of briefings, including our latest guidance for health and social care professionals, and guidance on supporting clients who want to stop vaping.

We are, like you, gaining clinical experience and expertise in helping our clients to quit using cytisine. As we learn more, we will develop more training and support materials for you.

Note: we use the name Cytisine as opposed to Cytisinicline but you may need to use 'cytisinicline' if looking for the medication in the British National Formulary, and GPs will certainly need to use it to prescribe electronically as it will be listed as this.

Here we include a NEW briefing, a summary and dosing guide, and the Summary of Product Characteristics. Plus information for a Medicines Management application to add cytisine to your formulary.

Nicotine replacement therapy (NRT) and the behaviour change techniques associated with its use are covered in our online training and assessment programme, specifically the Stop smoking medications module.

This section includes links to the Summary of Product Characteristics (SPC) for each NRT product.