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

a-s medication solutions - norgestrel (unii: 3j8q1747z2) (norgestrel - unii:3j8q1747z2), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestrel 0.3 mg - cryselle is indicated for use by females of reproductive potential to prevent pregnancy. in a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use. cryselle is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 have deep-vein thrombosis or pulmonary embolism, now or in the past have inherited or acquired coagulopathies have cerebrovascular disease have coronary artery disease have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation) have uncontrolled hypertension have diabetes mellitus with vascular disease headaches with focal neurological symptoms or migraine headaches with aura women over age 35 with any migra

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

remedyrepack inc. - norgestrel (unii: 3j8q1747z2) (norgestrel - unii:3j8q1747z2), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - cryselle is indicated for use by females of reproductive potential to prevent pregnancy. in a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use. do not prescribe cryselle to women who are known to have any of the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: - smoke, if over age 35 - have deep-vein thrombosis or pulmonary embolism, now or in the past - have inherited or acquired coagulopathies - have cerebrovascular disease - have coronary artery disease - have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation) - have uncontrolled hypertension - have diabetes mellitus with vascular disease - headaches with focal neurological symptoms or migraine headaches with aura - women over age 35 with any mig

Israel - English - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drl two weeks after initial assessment.

Israel - English - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drl two weeks after initial assessment.

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

rpk pharmaceuticals, inc. - norgestrel (unii: 3j8q1747z2) (norgestrel - unii:3j8q1747z2), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - cryselle is indicated for use by females of reproductive potential to prevent pregnancy. in a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use. cryselle is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 have deep-vein thrombosis or pulmonary embolism, now or in the past have inherited or acquired coagulopathies have cerebrovascular disease have coronary artery disease have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation) have uncontrolled hypertension have diabetes mellitus with vascular disease headaches with focal neurological symptoms or migraine headaches with aura women over age 35 with any migra

Israel - English - Ministry of Health

promedico ltd - selinexor - tablets - selinexor 20 mg - selinexor - multiple myeloma• xpovio® in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.• xpovio in combination with dexamethasone is indicated for the treatment of adult patients with relapsed refractory multiple myeloma (rrmm) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (pi), at least one immunomodulatory agent (imid), and an anti- cd38 monoclonal antibody (mab).diffuse large b-cell lymphomaxpovio is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl), not otherwise specified, including dlbcl arising from follicular lymphoma, after at least 2 lines of systemic therapy.

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

qed therapeutics, inc. - infigratinib (unii: a4055me1vk) (infigratinib - unii:a4055me1vk) - truseltiq is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or other rearrangement as detected by an fda-approved test [see dosage and administration ( 2.1)] . this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies ( 14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on findings in animal studies and its mechanism of action truseltiq can cause fetal harm or loss of pregnancy when administered to a pregnant woman [ see clinical pharmacology (13.1) ]. there are no available data on the use of truseltiq during pregnancy. oral administration of infigratinib to pregnant animals during the period of organogenesis at maternal exposures below the human exposure at

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

janssen-cilag pty ltd - guselkumab, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; histidine; sucrose; polysorbate 80; histidine hydrochloride monohydrate - plaque psoriasis,tremfya is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,tremfya is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior dmard therapy.

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

janssen-cilag pty ltd - guselkumab, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; sucrose; histidine hydrochloride monohydrate; histidine; polysorbate 80 - plaque psoriasis,tremfya is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,tremfya is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior dmard therapy.

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

preferred pharmaceuticals inc. - norgestrel (unii: 3j8q1747z2) (norgestrel - unii:3j8q1747z2), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - cryselle is indicated for use by females of reproductive potential to prevent pregnancy. in a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use. cryselle is contraindicated in females who are known to have or develop the following conditions: women who are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations (see warnings , risk of liver enzyme elevations with concomitant hepatitis c treatment).