New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - varenicline tartrate 1.71mg equivalent to 1 mg varenicline;  ;   - film coated tablet - 1 mg - active: varenicline tartrate 1.71mg equivalent to 1 mg varenicline     excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry blue 03b90547 opadry clear ys-2-19114-a - an aid to smoking cessation

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - varenicline tartrate 0.85mg equivalent to 0.5 mg varenicline;  ;  ; varenicline tartrate 1.71mg equivalent to 1 mg varenicline - combination - 0.5 mg and 1 mg - active: varenicline tartrate 0.85mg equivalent to 0.5 mg varenicline     excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry clear ys-2-19114-a opadry white ys-1-18202 active: varenicline tartrate 1.71mg equivalent to 1 mg varenicline excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry blue 03b90547 opadry clear ys-2-19114-a - an aid to smoking cessation

Canada - English - Health Canada

genmed a division of pfizer canada ulc - varenicline (varenicline tartrate) - tablet - 0.5mg - varenicline (varenicline tartrate) 0.5mg - miscellaneous autonomic drugs

Canada - English - Health Canada

genmed a division of pfizer canada ulc - varenicline (varenicline tartrate) - tablet - 1mg - varenicline (varenicline tartrate) 1mg - miscellaneous autonomic drugs

Canada - English - Health Canada

genmed a division of pfizer canada ulc - varenicline (varenicline tartrate); varenicline (varenicline tartrate) - kit - 0.5mg; 1mg - varenicline (varenicline tartrate) 0.5mg; varenicline (varenicline tartrate) 1mg - miscellaneous autonomic drugs

Canada - English - Health Canada

apotex inc - varenicline (varenicline tartrate) - tablet - 0.5mg - varenicline (varenicline tartrate) 0.5mg - miscellaneous autonomic drugs

Canada - English - Health Canada

apotex inc - varenicline (varenicline tartrate) - tablet - 1mg - varenicline (varenicline tartrate) 1mg - miscellaneous autonomic drugs

Canada - English - Health Canada

apotex inc - varenicline (varenicline tartrate); varenicline (varenicline tartrate) - kit - 0.5mg; 1mg - varenicline (varenicline tartrate) 0.5mg; varenicline (varenicline tartrate) 1mg - miscellaneous autonomic drugs

United States - English - NLM (National Library of Medicine)

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline tablets are indicated for use as an aid to smoking cessation treatment. varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline.   risk summary   available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations). in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk

United States - English - NLM (National Library of Medicine)

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline tablets are indicated for use as an aid to smoking cessation treatment. varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline.   risk summary   available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations). in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk