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

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - paracetamol, quantity: 1 g - injection, solution - excipient ingredients: glucose monohydrate; sodium citrate dihydrate; water for injections; glacial acetic acid; hydrochloric acid; sodium acetate trihydrate; sodium hydroxide - for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - paracetamol, quantity: 500 mg - injection, solution - excipient ingredients: hydrochloric acid; sodium citrate dihydrate; sodium acetate trihydrate; glucose monohydrate; sodium hydroxide; glacial acetic acid; water for injections - for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methotrexate, quantity: 500 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - antineoplastic chemotherapy - treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic and meningeal leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemia. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methotrexate is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. high dose therapy - the use of very high doses is made possible by vials for injection containing 500 mg and 1000 mg (see precautions). diseases treated with these doses administered in the form of single-drug or combination therapy, include osteogenic sarcoma, acute leukaemia, bronchogenic carcinoma and epidermoid carcinoma of the head and n

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

pfizer laboratories div pfizer inc - glasdegib (unii: k673dmo5h9) (glasdegib - unii:k673dmo5h9) - daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (aml) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. none. risk summary based on its mechanism of action and findings in animal embryo-fetal developmental toxicity studies, daurismo can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no clinical data on the use of daurismo in pregnant women to inform of a drug-associated risk of major birth defects and miscarriage. daurismo is not recommended for use during pregnancy. conduct pregnancy testing in female patients of reproductive potential prior to initiating treatment with daurismo. report pregnancy exposures to pfizer at 1-800-438-1985. in animal embryo-fetal developmental toxicity studies, repeat-dose oral administration of daurismo during organogenesis at maternal exposures that were less than the human exposu

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - latanoprost -

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methotrexate, quantity: 1000 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - antineoplastic chemotherapy - treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic and meningeal leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemia. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methotrexate is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. high dose therapy - the use of very high doses is made possible by vials for injection containing 500 mg and 1000 mg (see precautions). diseases treated with these doses administered in the form of single-drug or combination therapy, include osteogenic sarcoma, acute leukaemia, bronchogenic carcinoma and epidermoid carcinoma of the head and n

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methotrexate, quantity: 50 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - antineoplastic chemotherapy - treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic and meningeal leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemia. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methotrexate is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. high dose therapy - the use of very high doses is made possible by vials for injection containing 500 mg and 1000 mg (see precautions). diseases treated with these doses administered in the form of single-drug or combination therapy, include osteogenic sarcoma, acute leukaemia, bronchogenic carcinoma and epidermoid carcinoma of the head and n

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - daunorubicin, quantity: 20 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - indications as at 22 november 2004 : daunorubicin injection is indicated for the treatment of the following: acute lymphocytic (lymphoblastic) leukaemia: daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. however, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease. acute myeloblastic leukaemia: daunorubicin has been used in all stages, alone or in combination with other cytotoxic agents (e.g. cytarabine). disseminated solid tumours: daunorubicin has been investigated for use in these tumours and found to be effective in some cases of disseminated neuroblastoma and rhabdomyosarcoma.