Israel - inglês - Ministry of Health

tzamal bio-pharma ltd - 5-aminolevulinic acid as hydrochloride - powder for solution - 5-aminolevulinic acid as hydrochloride 1.5 g - aminolevulinic acid - aminolevulinic acid - gliolan® is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (who grade iii and iv).

União Europeia - inglês - EMA (European Medicines Agency)

photonamic gmbh & co. kg - 5-aminolevulinic acid hydrochloride - glioma - antineoplastic agents - gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (world health organization grade iii and iv).

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

specialised therapeutics limited - aminolevulinic acid hydrochloride 1.5 g - powder for oral solution - 1.5 g - active: aminolevulinic acid hydrochloride 1.5 g - gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme (gbm) on preoperative imaging , and who are intended for resection of the tumour.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

specialised therapeutics glio pty ltd - aminolevulinic acid hydrochloride, quantity: 1.5 g - oral liquid, powder for - excipient ingredients: - gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme (gbm) on preoperative imaging, and who are intended for resection of the tumour.

Israel - inglês - Ministry of Health

tzamal bio-pharma ltd - 5-aminolevulinic acid hydrochloride - powder for solution - 5-aminolevulinic acid hydrochloride 1.5 g - aminolevulinic acid - gliolan® is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (who grade iii and iv).

Cingapura - inglês - HSA (Health Sciences Authority)

link healthcare singapore pte ltd - aminolevulinic acid 23.4mg/ml equivalent aminolevulinic acid hydrochloride - powder, for solution - aminolevulinic acid 23.4mg/ml equivalent aminolevulinic acid hydrochloride 30mg/ml

Canadá - inglês - Health Canada

medexus pharmaceuticals inc. - aminolevulinic acid hydrochloride - powder for solution - 1.5g - aminolevulinic acid hydrochloride 1.5g - roentgenography

Estados Unidos - inglês - NLM (National Library of Medicine)

on target laboratories, inc. - pafolacianine sodium (unii: 4huf3v875c) (pafolacianine - unii:f7bd3z4x8l) - cytalux is indicated as an adjunct for intraoperative identification of: - malignant lesions in adult patients with ovarian cancer. - malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. none. risk summary based on its mechanism of action, pafolacianine may cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . there are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. no adverse developmental effects were observed in rats and rabbits with intravenous administration of pafolacianine during organogenesis (embryofetal development) at doses up to 158-fold (rat) and 570-fold (rabbit) the recommended human dose of 0.025 mg/kg based on auc, otherwise 9.6 and 38.4-fold based on human equivalent dose (hed) ( see data ). the estimated background risk of major birth defects and miscarriage for t

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

galderma (uk) ltd - methyl aminolevulinate hydrochloride - cream - 160 milligram(s) - sensitizers used in photodynamic/radiation therapy; methyl aminolevulinate

Austrália - inglês - APVMA (Australian Pesticides and Veterinary Medicines Authority)

apvma permit - carfentrazone-ethyl(240g/l) - group g herbicide