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

eli lilly and company - galcanezumab (unii: 55khl3p693) (galcanezumab - unii:55khl3p693) - emgality is indicated for the preventive treatment of migraine in adults. emgality is indicated for the treatment of episodic cluster headache in adults. emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emgality during pregnancy. healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724 or by contacting the company at www.migrainepregnancyregistry.com. risk summary there are no adequate data on the developmental risk associated with the use of emgality in pregnant women. administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects

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

eli lilly australia pty ltd - galcanezumab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; water for injections; histidine; sodium chloride; polysorbate 80 - emgality is indicated for the prophylaxis of migraine in adults.

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

eli lilly australia pty ltd - galcanezumab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; water for injections; polysorbate 80; sodium chloride; histidine hydrochloride monohydrate - emgality is indicated for the prophylaxis of migraine in adults.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - galcanezumab - solution for injection - galcanezumab 120 mg / 1 ml - galcanezumab - emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - galcanezumab -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - galcanezumab -

European Union - English - EMA (European Medicines Agency)

eli lilly nederland b.v. - galcanezumab - migraine disorders - analgesics, galcanezumab - emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

Canada - English - Health Canada

eli lilly canada inc - galcanezumab - solution - 120mg - galcanezumab 120mg - calcitonin-gene-related peptide (cgrp) antagonists

Canada - English - Health Canada

eli lilly canada inc - galcanezumab - solution - 120mg - galcanezumab 120mg - calcitonin-gene-related peptide (cgrp) antagonists

New Zealand - English - Medsafe (Medicines Safety Authority)

eli lilly and company (nz) limited - galcanezumab 120 mg/ml - solution for injection - 120 mg/ml - active: galcanezumab 120 mg/ml excipient: histidine histidine hydrochloride monohydrate polysorbate 80 sodium chloride water for injection - emgality is indicated for the prophylaxis of migraine in adults