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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine supplied in a multiple dose vial with a gray cap and label with a gray border, which is authorized for use in individuals 12 years of age and older. do not administer pfizer-biontech covid-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data on pfizer

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine supplied in a multiple dose vial with an orange cap and a label with an orange border, which is authorized for use in individuals 5 through 11 years of age. the vial labels state: age 5y to <12y. the carton labels state: for age 5 years to <12 years. do not administer pfizer-biontech covid-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage i

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj), famtozinameran (unii: jsv288q5cv) (famtozinameran - unii:jsv288q5cv) - pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 12 years of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5), hereafter referred to as pfizer-biontech covid-19 vaccine, bivalent. do not administer pfizer-biontech covid-19 vaccine, bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine or the pfizer-biontech covid-19 vaccine, bivalent [see description (13)] . risk summary no data are available regarding the use of pfizer-biontech covid-19 vaccine, bivalent during pregnancy. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, t

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 16.7mg equivalent to sunitinib 12.5mg;   - capsule - 12.5 mg - active: sunitinib malate 16.7mg equivalent to sunitinib 12.5mg   excipient: croscarmellose sodium gelatin ink iron oxide red magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 33.4mg equivalent to sunitinib 25mg;   - capsule - 25 mg - active: sunitinib malate 33.4mg equivalent to sunitinib 25mg   excipient: croscarmellose sodium gelatin ink iron oxide black iron oxide red iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 50.1mg equivalent to sunitinib 37.5mg;   - capsule - 37.5 mg - active: sunitinib malate 50.1mg equivalent to sunitinib 37.5mg   excipient: croscarmellose sodium gelatin ink iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sunitinib malate 66.8mg equivalent to sunitinib 50mg;   - capsule - 50 mg - active: sunitinib malate 66.8mg equivalent to sunitinib 50mg   excipient: croscarmellose sodium gelatin ink iron oxide black iron oxide red iron oxide yellow magnesium stearate mannitol povidone sodium laurilsulfate titanium dioxide - treatment of advanced renal cell carcinoma

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer limited - amlodipine besilate - tablets - 10 milligram - dihydropyridine derivatives

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer limited - amlodipine besilate - tablets - 5 milligram - dihydropyridine derivatives

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer limited - ziprasidone hydrochloride monohydrate - capsules hard - 40 milligram