Evropská unie - angličtina - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, non-small-cell lung - antineoplastic agents - tremelimumab astrazeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Spojené státy - angličtina - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride anhydrous 30 mg - cevimeline hydrochloride is indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline hydrochloride is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

Spojené státy - angličtina - NLM (National Library of Medicine)

rising pharma holdings, inc. - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride anhydrous 30 mg - cevimeline is indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

Spojené státy - angličtina - NLM (National Library of Medicine)

novel laboratories, inc. - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride anhydrous 30 mg - cevimeline is indicated for the treatment of symptoms of dry mouth in patients with sjÖgren's syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

Evropská unie - angličtina - EMA (European Medicines Agency)

eli lilly nederland b.v. - duloxetine - neuralgia; diabetic neuropathies; depressive disorder, major - psychoanaleptics, - duloxetine lilly is indicated in adults for:treatment of major depressive disordertreatment of diabetic peripheral neuropathic paintreatment of generalised anxiety disorderduloxetine lilly is indicated in adults.

Evropská unie - angličtina - EMA (European Medicines Agency)

eli lilly netherlands - pemetrexed - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed lilly 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 lilly 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 lilly 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.

Evropská unie - angličtina - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafil - erectile dysfunction - urologicals - treatment of erectile dysfunction in adult males.in order for tadalafil to be effective, sexual stimulation is required.tadalafil lilly is not indicated for use by women.treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

Spojené státy - angličtina - NLM (National Library of Medicine)

endo usa, inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - supprelin la (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (cpp). children with cpp (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). they also show a significantly advanced bone age that can result in diminished adult height attainment. prior to initiation of treatment a clinical diagnosis of cpp should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (lh) and follicle stimulating hormone (fsh) following stimulation with a gnrh analog, and assessment of bone age versus chronological age. baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia. supprelin la is contraindicated in: - patients who are hypersensitive to gonadotropin releasing hormone (gnrh) or gnrh agonist analogs - pregnancy [see use in specific populations (8.1) ]. risk summary supprelin la is contraindicated during pregnancy [see contraindications (4)] since expected hormonal changes that occur with supprelin la treatment increase the risk for pregnancy loss. the limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. consistent with mechanism of action for supprelin la [see clinical pharmacology (12.1)], animal reproduction studies showed an increase in fetal loss at clinically relevant exposures. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data histrelin acetate administered to pregnant rats during the period of organogenesis increased fetal mortality and post-implantation loss at doses of 1, 3, 5 or 15 mcg/kg/day, approximating clinical exposure based on body surface area. these dosages also reduced maternal body weight gain, stimulated ovarian follicular development, increased placental weight and caused abnormal morphology and an increase in fetal size. histrelin acetate administered to pregnant rabbits during the period of organogenesis increased fetal mortality and abortion/early termination at the two highest doses and caused total litter loss at all doses of 20, 50 or 80 mcg/kg/day (approximately 3- to 12-times clinical exposures based on body surface area). risk summary there are no data on the presence of supprelin la in human or animal milk, the effects on the breastfed infant, or the effects on milk production. absorption and systemic activity are not expected from potential exposure to the peptide, histrelin, in the breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for supprelin la and any potential adverse effects on the breastfed child from supprelin la or from the underlying maternal condition. safety and effectiveness in pediatric patients below the age of 2 years have not been established. the use of supprelin la in children under 2 years is not recommended.

Spojené státy - angličtina - NLM (National Library of Medicine)

ingenus pharmaceuticals nj, llc - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride 30 mg

Spojené státy - angličtina - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.