Regulatory PathRegulatory requirements compared

Active substance

Varenicline

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CHAMPIX 0.5 MG 11 tablets +1 MG 14 tablets0.5-1 mgFilm-coated tablet · Oral use25 BlisterSAR 133.40NCE · PrescriptionPfizer Europe MA EEIGValid
CHAMPIX 0.5 MG F-C TAB0.5 mgFilm-coated tablet · Oral use56 BlisterSAR 138.50NCE · PrescriptionPfizer Europe MA EEIGValid
CHAMPIX 1MG F-C TABLETS1 mgFilm-coated tablet · Oral use56 BlisterSAR 224.55NCE · PrescriptionPfizer Europe MA EEIGValid
CHAMPIX 1MG F-C TABLETS1 mgFilm-coated tablet · Oral use28 BlisterSAR 133.40NCE · PrescriptionPfizer Europe MA EEIGValid
Cigapix1 mgFilm-coated tablet · Oral use56 BlisterSAR 179.65Generic · PrescriptionSaudi AmaroxValid
Cigapix0.5 mgFilm-coated tablet · Oral use56 BlisterSAR 110.80Generic · PrescriptionSaudi AmaroxValid
Cimuquit0.5 & 1 mgFilm-coated tablet · Oral use25 BlisterSAR 115.60Generic · PrescriptionBATTERJEE PHARMACETICAL FACTORYValid
Cimuquit0.5 mgFilm-coated tablet · Oral use56 BlisterSAR 120.00Generic · PrescriptionBATTERJEE PHARMACETICAL FACTORYValid
Cimuquit1 mgFilm-coated tablet · Oral use56 BlisterSAR 194.60Generic · PrescriptionBATTERJEE PHARMACETICAL FACTORYValid
Herocan0.5 mgFilm-coated tablet · Oral use56 BlisterSAR 110.80Generic · PrescriptionAPOTEXValid
Herocan1 mgFilm-coated tablet · Oral use56 BlisterSAR 179.65Generic · PrescriptionAPOTEXValid
Herocan1 mgFilm-coated tablet · Oral use28 BlisterSAR 106.70Generic · PrescriptionAPOTEXValid
Herocan1,0.5 mg,mgFilm-coated tablet · Oral use25 BlisterSAR 106.70Generic · PrescriptionAPOTEXValid
Herocan0.5 mgFilm-coated tablet · Oral use56 BottleSAR 110.80Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Valid
Herocan1 mgFilm-coated tablet · Oral use56 BottleSAR 179.65Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Valid
Herocan0.5 mgFilm-coated tablet · Oral use28 BlisterSAR 55.40Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Valid
Marvi0.5 mgFilm-coated tablet · Oral use14 BlisterSAR 30.00Generic · PrescriptionSPIMACO ADDWAEIHValid
Marvi1 mgFilm-coated tablet · Oral use30 BlisterSAR 123.85Generic · PrescriptionSPIMACO ADDWAEIHValid
Serna1,0.5 mg,mgFilm-coated tablet · Oral use25 BlisterSAR 106.70Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Serna1 mgFilm-coated tablet · Oral use56 BlisterSAR 179.65Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Serna1 mgFilm-coated tablet · Oral use28 BlisterSAR 106.70Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
VarNell0.5/1 mgFilm-coated tablet · Oral use25 BlisterSAR 106.70Generic · PrescriptionKinnova manufacturing companyValid
VarNell1 mgFilm-coated tablet · Oral use56 BlisterSAR 179.65Generic · PrescriptionKinnova manufacturing companyValid
Varenapix0.5 mgFilm-coated tablet · Oral use30 BlisterSAR 59.35Generic · PrescriptionSpectro PharmaValid
Varenapix1 mgFilm-coated tablet · Oral use30 BlisterSAR 106.65Generic · PrescriptionSpectro PharmaValid

5 more — full table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
CHANTIXEQ 0.5MG BASE; EQ 1MG BASEtablet · oralPF PRISM CVPrescription10 May 2006
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralPH HEALTHPrescription11 Aug 2021
TYRVAYAEQ 0.03MG BASE/SPRAYspray · nasalOYSTER POINT PHARMAPrescription15 Oct 2021
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralAPOTEXPrescription25 Jan 2023
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralZYDUSPrescription12 Jun 2023
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralKANCHAN HLTHCAREPrescription25 Jul 2023
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralMANKIND PHARMAPrescription1 Aug 2023
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralALKEM LABS LTDPrescription23 Aug 2023
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralHETERO LABS LTD IIIPrescription23 Oct 2023
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralLUPINPrescription4 Dec 2023
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralNE RX PHARMAPrescription6 Mar 2024
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralAJANTA PHARMA LTDPrescription19 Mar 2024
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralPIRAMALPrescription23 Jul 2024
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralDR REDDYSPrescription1 Oct 2024
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralREGCON HOLDINGSPrescription29 Oct 2024
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralMACLEODS PHARMSPrescription9 Dec 2024
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralADAPTISPrescription8 Apr 2025
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralAUROBINDO PHARMAPrescription2 May 2025
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralVIWIT PHARMPrescription6 May 2025
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralMICRO LABSPrescription29 Oct 2025
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralUMEDICAPrescription9 Jan 2026
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralSOMERSET THERAPS LLCPrescription6 Jul 2026
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralPHARMOBEDIENTDiscontinued29 Feb 2024
VARENICLINE TARTRATEEQ 0.5MG BASE; EQ 1MG BASEtablet · oralRHODES PHARMSDiscontinued21 May 2025

EMA European Union — centrally authorised medicines

Champix Pfizer Europe MA EEIG · Authorised · authorised 25 Sep 2006 · ATC N07BA03

Therapeutic indication (EMA)

Champix is indicated for smoking cessation in adults.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-VARENICLINE024198820.5 MGTABLET · ORALAPOTEX INC
APO-VARENICLINE024198901 MGTABLET · ORALAPOTEX INC
APO-VARENICLINE024356750.5 MG; 1 MGKIT; TABLET · ORALAPOTEX INC
AURO-VARENICLINE025544450.5 MGTABLET · ORALAURO PHARMA INC
AURO-VARENICLINE025544531 MGTABLET · ORALAURO PHARMA INC
MINT-VARENICLINE025469490.5 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-VARENICLINE025469571 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-VARENICLINE025469650.5 MG; 1 MGKIT; TABLET · ORALMINT PHARMACEUTICALS INC
NRA-VARENICLINE025429510.5 MGTABLET · ORALNORA PHARMA INC
NRA-VARENICLINE025429781 MGTABLET · ORALNORA PHARMA INC
NRA-VARENICLINE025429860.5 MG; 1 MGTABLET; KIT · ORALNORA PHARMA INC
ZDS-VARENICLINE025598970.5 MGTABLET · ORALZYDUS LIFESCIENCES LIMITED
ZDS-VARENICLINE025599001 MGTABLET · ORALZYDUS LIFESCIENCES LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCHANTIX 1 MG CONT MONTH BOX$3.40803per EA23 Sep 2026
US NADACCHANTIX 1 MG TABLET$3.40803per EA23 Sep 2026
US NADACTYRVAYA 0.03 MG NASAL SPRAY$79.62813per ML23 Sep 2026
US NADACVARENICLINE 0.5 MG TABLET$0.31158per EA23 Sep 2026
US NADACVARENICLINE 1 MG TABLET$0.3161per EA23 Sep 2026
NHS Drug TariffVarenicline 1mg tablets£18.1628 tablet1 Oct 2026
NHS Drug TariffVarenicline 1mg tablets and Varenicline 500microgram tablets£27.3025 tablet1 Oct 2026
NHS Drug TariffVarenicline 1mg tablets and Varenicline 500microgram tablets£40.9553 tablet1 Oct 2026
NHS Drug TariffVarenicline 500microgram tablets£54.6056 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 24.5.2. Medicines for nicotine use disorders · core
    Nicotine dependence
    Oral > Solid: 0.5 mg; 1 mg

Safety signals and safety-related labeling changes

All safety entries for varenicline →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.