USA - engelsk - 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).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - selumetinib sulfate, quantity: 30.25 mg (equivalent: selumetinib, qty 25 mg) - capsule, hard - excipient ingredients: carnauba wax; hypromellose; titanium dioxide; carrageenan; shellac; iron oxide red; purified water; iron oxide yellow; tocofersolan; indigo carmine aluminium lake; glyceryl monooleate; potassium chloride; indigo carmine - koselugo is indicated for the treatment of paediatric patients aged 2 years and above, with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - selumetinib sulfate, quantity: 12.1 mg (equivalent: selumetinib, qty 10 mg) - capsule, hard - excipient ingredients: titanium dioxide; carnauba wax; potassium chloride; iron oxide black; tocofersolan; strong ammonia solution; shellac; propylene glycol; purified water; carrageenan; hypromellose - koselugo is indicated for the treatment of paediatric patients aged 2 years and above, with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

Sydafrika - engelsk - South African Health Products Regulatory Authority (SAHPRA)

pharma-q holdings (pty) ltd - injection - see ingredients - each 1 ml liquid contains epinephrine bitartrate 1,80 mg equivalent to epinephrine 1 mg

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - alcohol-related disorders - drugs used in alcohol dependence - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), 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 drinking-risk level two weeks after initial assessment.

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - maraviroc (unii: md6p741w8a) (maraviroc - unii:md6p741w8a) - maraviroc 300 mg - selzentry, in combination with other antiretroviral agents, is indicated for adult patients infected with only ccr5-tropic hiv-1. this indication is based on analyses of plasma hiv-1 rna levels in two controlled studies of selzentry in treatment-experienced subjects and one study in treatment-naïve subjects. both studies in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral-experienced (nrti, nnrti, pi, or enfuvirtide) adults with evidence of hiv-1 replication despite ongoing antiretroviral therapy. the following points should be considered when initiating therapy with selzentry: - adult patients infected with only ccr5-tropic hiv-1 should use selzentry. - tropism testing must be conducted with a highly sensitive tropism assay that has demonstrated the ability to identify patients appropriate for selzentry use. outgrowth of pre-existing low-level cxcr4- or dual/mixed-tropic hiv-1 not detected by tropism testing at screening has been associated with virologic failure o

USA - engelsk - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - 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

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - gabapentin, quantity: 300 mg - capsule, hard - excipient ingredients: maize starch; lactose; purified talc; titanium dioxide; purified water; iron oxide yellow; gelatin; sodium lauryl sulfate - pharmagabapentin is indicated for the treatment of,? partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,? neuropathic pain.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - gabapentin, quantity: 400 mg - capsule, hard - excipient ingredients: maize starch; lactose; purified talc; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - pharmagabapentin is indicated for the treatment of,? partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,? neuropathic pain.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - gabapentin, quantity: 100 mg - capsule, hard - excipient ingredients: lactose; purified talc; maize starch; titanium dioxide; purified water; gelatin; sodium lauryl sulfate - pharmagabapentin is indicated for the treatment of,? partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,? neuropathic pain.