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

juno pharmaceuticals pty ltd - hexaminolevulinate hydrochloride -

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

endotherapeutics pty ltd - hexaminolevulinate hydrochloride, quantity: 100 mg (equivalent: hexaminolevulinate, qty 85 mg) - diluent, not applicable - excipient ingredients: sodium hydroxide; dibasic sodium phosphate dihydrate; monobasic potassium phosphate; sodium chloride; water for injections; hydrochloric acid - this medicinal product is for diagnostic use only.,hexvix blue light fluorescence cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer.

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

photocure inc - hexaminolevulinate hydrochloride (unii: d4f329sl1o) (hexaminolevulinate - unii:g7h20tki67) - hexaminolevulinate hydrochloride 100 mg in 50 ml - cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. cysview is used with the karl storz d-light c photodynamic diagnostic (pdd) system to perform cystoscopy with the blue light setting (mode 2) as an adjunct to the white light setting (mode 1). cysview is not: - a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see warnings and precautions (5.2) ]. - for repetitive use. the potential risks associated with repetitive exposure, including sensitization and adverse effects of blue light have not been evaluated [see warnings and precautions (5.1) ]. cysview is contraindicated in patients with: - porphyria - gross hematuria - bcg immunotherapy or intravesical chemotherapy within the past 90 days - known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid pregnancy

Israel - English - Ministry of Health

igl medical ltd - hexaminolevulinate as hydrochloride - powder and solvent for intravesical solution - hexaminolevulinate as hydrochloride 85 mg/vial - this medicinal product is for diagnostic use only.hexvix blue light fluorescence cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer.

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

photocure inc. - hexaminolevulinate hydrochloride (unii: d4f329sl1o) (hexaminolevulinate - unii:g7h20tki67) - hexaminolevulinate hydrochloride 100 mg in 50 ml - cysview is indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (cis), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. cysview is used with the karl storz d-light c photodynamic diagnostic (pdd) system to perform blue light cystoscopy (blc ® ) as an adjunct to the white light cystoscopy. cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [ see warnings and precautions (5.2) ]. cysview is contraindicated in patients with: - porphyria, - gross hematuria, - known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. risk summary there are no available data on cysview use in pregnant women to inform a drug associated risk of adverse developmental outcomes. adequate reproductive and developmental toxicity studie

Malta - English - Medicines Authority

ipsen m.e.p.e ag. dimitriou 63 alimos, 17456 athens, greece - hexaminolevulinate - powder and solvent for solution for intravesical use - hexaminolevulinate 85 mg - diagnostic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

endotherapeutics nz limited - hexaminolevulinate hydrochloride 100mg equivalent to hexaminolevulinate 85mg - powder for injection - 85 mg - active: hexaminolevulinate hydrochloride 100mg equivalent to hexaminolevulinate 85mg excipient: dibasic sodium phosphate dihydrate hydrochloric acid monobasic potassium phosphate sodium chloride sodium hydroxide water for injection - hexvix® is indicated for diagnostic use only. hexvix blue light fluorescence cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer.

Canada - English - Health Canada

photocure asa - hexaminolevulinate hydrochloride - kit - 100mg - hexaminolevulinate hydrochloride 100mg - other diagnostic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

ipsen pharmaceuticals limited - hexaminolevulinate hydrochloride - pdr+solv/soln/intravesical use - 85 milligram(s) - other diagnostic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

photocure asa - hexaminolevulinate hydrochloride - powder and solvent for intravesical solution - 85mg