Champix - supply shortage
Ongoing
varenicline
Shortage
Human
Shortage information
There is a supply shortage in the EU of Champix, a medicine used by adults to help them stop smoking.
For further information on the use of the medicine please refer to the medicine’s overview page.
The company that markets Champix had to change the way the medicine was being produced to ensure that the nitrosamine impurity N-nitroso-varenicline is below acceptable levels. While this was ongoing, the company recalled batches and paused distribution, which led to a shortage of Champix.
EMA has since approved the changes to the way the medicine is produced and the shortage is now being resolved.
More information about the risk of nitrosamine impurities in human medicines can be found here: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities
All EU Member States where Champix is marketed (all Member States except Bulgaria) have been affected; the supply of Champix resumed in March 2025 and is expected to be restored by the end of June 2025.
For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register or contact the national competent authority.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
- EMA has approved a newly manufactured Champix to ensure that the level of a nitrosamine impurity called N-nitroso-varenicline is below the acceptable intake limit during production and throughout the product’s shelf-life.
- The supply of Champix resumed in March 2025 and is expected to be restored by the end of June 2025.
- For additional information consult your country’s shortage register or contact your national competent authority.
- EMA has approved a newly manufactured Champix to ensure that the level of an impurity called N-nitroso-varenicline is below the acceptable intake limit during production and throughout the product’s shelf-life.
- The supply of Champix resumed in March 2025 and are expected to be restored by the end of June 2025.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- Champix
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- varenicline
- Therapeutic area (MESH)
- Tobacco Use Cessation
- Pharmaceutical forms affected
- Film-coated tablet
- Strengths affected
- 0.5 mg
- 1 mg
- Availability of alternatives
- Yes
Key dates
- Expected resolution
- June 2025
- First published
- Last updated