Ireland - English - HPRA (Health Products Regulatory Authority)

photocure asa - hexaminolevulinate hydrochloride - powder and solvent for intravesical solution - 85 milligram(s) - other diagnostic agents

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

penn pharmaceutical services ltd. - methyl aminolevulinate hydrochloride (unii: 7s73606o1a) (methyl aminolevulinate - unii:585nm85kym) - cream - 168 mg in 1 g - metvixia cream in combination with 570 to 670 nm wavelength red light illumination using the curelight broadband model curelight 01 lamp is indicated for treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physician’s office when other therapies are unacceptable or considered medically less appropriate. metvixia cream is contraindicated in patients with cutaneous photosensitivity, or known allergies to porphyrins, and in patients with known sensitivities to any of the components of metvixia cream, which includes peanut and almond oil (see warnings regarding sensitivity to metvixia cream). this product contains refined peanut oil (see precautions).

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

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

Canada - English - Health Canada

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

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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

photocure asa - hexaminolevulinate hydrochloride 100 mg - eq. hexaminolevulinate 85 mg - powder and solvent for intravesical solution - 85 mg - hexaminolevulinate hydrochloride - other diagnostic agents

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

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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