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varenicline

Champix · ATC code N07BA03

Also known as: Vareniclin · Brand names: Champix, Civarenix, Vareniclin Ascend, Vareniclin Axunio, Vareniclin Bluefish, Vareniclin Glenmark, Vareniclin Macleods, Vareniclin Medichem, Vareniclin Ratiopharm, Vareniclin Viatris, Dupons

Key facts
Active substance
varenicline
ATC code
N07BA03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
CHAMPIX 0.5 mg film-coated tablets · CHAMPIX 1 mg film-coated tablets · CHAMPIX 0.5 mg film-coated tablets / CHAMPIX 1 mg film-coated tablets
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-27

Key facts

Varenicline is a nicotinic acetylcholine receptor partial agonist (Champix film-coated tablets). It is used for smoking cessation in adults.

What it is used for

  • Smoking cessation in adults

Dosing

  • Days 1 – 3: 0.5 mg once daily; days 4 – 7: 0.5 mg twice daily; from day 8: 1 mg twice daily
  • Start 1-2 weeks before the set quit date; treat for 12 weeks, with an optional further 12 weeks if successful
  • Gradual quitting: reduce smoking in the first 12 weeks, 24 weeks of treatment in total
  • If adverse reactions are not tolerated, lower to 0.5 mg twice daily
  • Severe renal impairment (creatinine clearance < 30 ml/min): 1 mg once daily after starting at 0.5 mg; not recommended in end-stage renal disease

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Neuropsychiatric symptoms (e.g. depression, suicidal ideation, aggressive behaviour) reported post-marketing
  • Smoking cessation itself may change the effect of other medicines (e.g. theophylline, warfarin, insulin)
  • Seizures; caution in patients with a history of seizures
  • Cardiovascular events: report new or worsening symptoms; hypersensitivity reactions including angioedema
  • After stopping, increased irritability and urge to smoke; consider tapering if relapse risk is high

Side effects

  • Most common: nausea (28.6%), mostly early in treatment and mild to moderate
  • Also very common: nasopharyngitis, abnormal dreams, insomnia, headache
  • Rare: suicidal ideation, aggression, panic reaction

Interactions

  • No clinically meaningful drug interactions
  • Stopping smoking may increase levels of CYP1A2 substrates; dose adjustment of e.g. theophylline or warfarin may be needed

Pregnancy and breastfeeding

  • Pregnancy: as a precaution, use should preferably be avoided
  • Breast-feeding: excretion in human milk unknown; benefit-risk decision

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ChampixPfizer Europe MA EEIG · EMEA/H/C/000699

Source: European Medicines Agency (EMA), product information

Austria

  • CivarenixG.L. Pharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Vareniclin AscendAscend Gmbh · 1 register entry
  • Vareniclin AxunioAxunio Pharma Gmbh · 1 register entry
  • Vareniclin BluefishBluefish Pharmaceuticals Ab · 1 register entry
  • Vareniclin GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
  • Vareniclin MacleodsMacleods Pharma España, S.L.U · 1 register entry
  • Vareniclin MedichemMedichem, S.A. · 1 register entry
  • Vareniclin RatiopharmRatiopharm Gmbh · 2 register entries
  • Vareniclin ViatrisViatris Germany Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • ChampixPFİZER PFE İLAÇLARI A.Ş. · 6 register entries
  • DuponsABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 6 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 16 more European countries
Belgium
Varenicline Ab, Varenicline Eg, Varenicline Teva
Czechia
Civarenix, Varenicline Glenmark, Vareniklin Viatris
Denmark
Civarenix, Vareniclin Axunio, Varenicline Bluefish, Varenicline Orion, Varenicline Stada, Varenicline Viatris, Varenicline Zentiva
Finland
Varenicline Glenmark, Varenicline Orion, Varenicline Ratiopharm, Varenicline Stada Stada, Varenicline Viatris, Varenikliini Axunio
France
Varenicline
Iceland
Champix, Vareniclin Normon, Varenicline Newbury, Varenicline Teva
Ireland
Varenicline Ascend, Varenicline Teva
Italy
Civarenix, Vareniclina Aurobindo, Vareniclina Mylan, Vareniclina Zentiva
Liechtenstein
Champix
Luxembourg
Vareniclin Ratiopharm, Vareniclin Starterpackung Ratiopharm, Varenicline Eg
Malta
Varenicline Glenmark
Netherlands
Byteqi, Cuitvar, Exchampra, Varenicline Axunio, Varenicline Cf, Varenicline Faye, Varenicline Glenmark, Varenicline Teva, Varenicline Viatris
Norway
Champix, Varenicline Bluefish, Varenicline Orion, Varenicline Viatris, Varenicline Zentiva, Vareniklin Axunio
Portugal
Cuitvar, Exchampra, Vareniclina Aurobindo, Vareniclina Clapix, Vareniclina Generis Phar, Vareniclina Zentiva, Varenicline Viatris
Spain
Byteqi, Cuitvar, Exchampra, Vareniclina Aurovitas, Vareniclina Cinfa, Vareniclina Combix, Vareniclina Kern Pharma, Vareniclina Macleods, Vareniclina Medichem, Vareniclina Normon, Vareniclina Stada, Vareniclina Teva, Vareniclina Zentiva, Zampitex
Sweden
Civarenix, Varenicline Bluefish, Varenicline Glenmark, Varenicline Newbury, Varenicline Orion, Varenicline Stada Stada, Varenicline Teva, Varenicline Zentiva, Vareniklin Axunio

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Champix – EPAR, Product Information (OF THE TEXT Detailed information on this product is availabl). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/champix-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.