European Union - English - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - carcinoma, non-small-cell lung - antineoplastic agents - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

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

merck healthcare pty ltd - tepotinib hydrochloride monohydrate, quantity: 250 mg (equivalent: tepotinib, qty 225 mg) - tablet, film coated - excipient ingredients: mannitol; crospovidone; magnesium stearate; colloidal anhydrous silica; hypromellose; titanium dioxide; lactose monohydrate; macrogol 3350; triacetin; iron oxide red; microcrystalline cellulose - tepmetko has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) harbouring mesenchymal-epithelial transition (met) exon 14 skipping alterations.,the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

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

tmig inc - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine hydrochloride 10 mg - cyclobenzaprine hcl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. cyclobenzaprine hcl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hcl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. hypersensitivity to any component of this product. concomitant use of monoamine oxidase (mao) inhibitors or within 14 days after their discontinuation. hyperpyretic cri

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

redpharm drug, inc. - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride is contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see adverse reactions (6) and description (11)] . risk summary data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. however, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data human da

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

redpharm drug, inc. - benzonatate (unii: 5p4dhs6enr) (benzonatate - unii:5p4dhs6enr) - benzonatate is indicated for the symptomatic relief of cough. hypersensitivity to benzonatate or related compounds.

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

redpharm drug, inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) -

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

redpharm drug, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies   ( 14.1) ]. meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies   ( 14.1) ]. meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [ see dosage and administration ( 2.4) and clinical studies ( 14.2) ]. meloxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or othe

Singapore - English - HSA (Health Sciences Authority)

merck pte. ltd. - tepotinib hydrochloride hydrate eqv tepotinib - tablet, film coated - tepotinib hydrochloride hydrate eqv tepotinib 225mg

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

merck biopharma co., ltd - tepotinib hydrochloride hydrate - whitish soft red tablet, major axis: 18 mm, minor axis: 9 mm, thickness: 6.9 mm

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

redpharm drug, inc. - diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m) - antihistamine - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose  itchy, watery eyes sneezing itching of the nose or throat - runny nose  - itchy, watery eyes - sneezing - itching of the nose or throat - temporarily relieves these symptoms due to the common cold: runny nose sneezing - runny nose - sneezing