Baricitinib
Summary of product characteristics
Effective Time
20220510
Version
3
Spl Product Data Elements
Baricitinib baricitinib baricitinib baricitinib Mannitol Cellulose, Microcrystalline Croscarmellose Sodium Magnesium Stearate medium pink round Lilly;4
Brand Name
Baricitinib
Generic Name
baricitinib
Product Ndc
0002-6885
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL – BARICITINIB 4 mg 30ct Bottle Rx Only NDC 0002-6885-30 baricitinib tablets 4 mg For use under Emergency Use Authorization (EUA). 30 tablets Lilly PACKAGE LABEL – OLUMIANT 4 mg 30ct Bottle
Spl Unclassified Section
FACT SHEET FOR HEALTHCARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIB The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has been authorized by FDA for the emergency uses described above. Baricitinib is not FDA-approved for these uses. Baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of baricitinib under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
Spl Unclassified Section Table
60 mins
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