Table 1.
Region | First Approval Date | Current Indications |
---|---|---|
Francea | October 1987 | Onchocerciasis, strongyloidiasis, lymphatic filariasis, human sarcoptic scabies |
United Statesb | November 1996 | Onchocerciasis, strongyloidiasis |
Australiac | June 1997 | Onchocerciasis, strongyloidiasis, human sarcoptic scabies, crusted scabies |
Japand | October 2002 | Strongyloidiasis, human sarcoptic scabies, crusted scabies |
Netherlandse | March 2003 | Strongyloidiasis, lymphatic filariasis, human sarcoptic scabies |
New Zealandf | August 2005 | Strongyloidiasis, lymphatic filariasis, human sarcoptic scabies |
Germanya | February 2016 | Strongyloidiasis, lymphatic filariasis, human sarcoptic scabies |
Canadag | September 2018 | Onchocerciasis, strongyloidiasis |
aEuropean Medicines Agency. Ivermectin (systemic use): List of nationally authorized medicinal products. Human Medicines Evaluation Division. Available at (accessed February 3, 2019): [https://www.ema.europa.eu/documents/psusa/ivermectin-systemic-use-list-nationally-authorised-medicinal-products-psusa/00002959/201502_en.pdf]
bFood and Drug Administration. Labelling and Clinical Review of Final Printed Labelling: Stromectol (Ivermectin) 3 mg tablets (New Formulation). Center for Drug Evaluation and Research. 2000. Available at (accessed February 3, 2019): [https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50-742s001_Stromectol_AdminCorres.PDF]
cTherapeutic Goods Administration. AusPAR Product Information: Stromectol Tablets. 2013 Jul; Accessible at (accessed February 3, 2019): [https://www.tga.gov.au/sites/default/files/auspar-ivermectin-131030-pi.pdf]
dPharmaceuticals and Medical Devices Agency. FY2006 List of Approved Products: New Drugs. 2006; Available at (accessed February 3, 2019): [https://www.pmda.go.jp/files/000153730.pdf]
eMedicines Evaluation Board. Public Assessment Report – Scientific Discussion: Ivermectin Substipharm 3 mg tablets. 2018 Jul; Accessible at (accessed February 3, 2019): [https://db.cbg-meb.nl/Pars/h120488.pdf]
fMedsafe. Medsafe Product Detail: Stromectol tablet 3 mg. 2018 Feb; Accessible at (accessed February 3, 2019): [https://www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=11299]
gHealth Canada. Drug and health product submissions under review (SUR). Government of Canada. 2018. Available at (accessed February 3, 2019): [https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html]