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Table 1 First market approvals and current indications of ivermectin by country

From: 2018 in review: five hot topics in tropical medicine

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

  1. 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]
  2. 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]
  3. 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]
  4. 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]
  5. 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]
  6. 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]
  7. 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]
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Tropical Diseases, Travel Medicine and Vaccines

ISSN: 2055-0936

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