onitor you during treatment to watch for signs and symptoms of all the serious side effects.
The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.
These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to MT Pharma America, Inc. at 1-888-292-0058 orFDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the ingredients in RADICAVA?
Active ingredient: edaravone
Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid and sodium hydroxide.
Marketed and distributed by: MT Pharma America, Inc., a US subsidiary of Mitsubishi Tanabe Pharma Corporation, 525 Washington Blvd., Suite 400, Jersey City, NJ 07310
For more information, go to www.Radicava.com or call 1-888-292-0058.
This Patient Information or Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 05/17
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
radicava_bag
PACKAGE/LABEL DISPLAY PANEL
carton
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
shipping-label
INGREDIENTS AND APPEARANCE
RADICAVA
edaravone injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70510-2171
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EDARAVONE (UNII: S798V6YJRP) (EDARAVONE - UNII:S798V6YJRP) EDARAVONE 30 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BISULFITE (UNII: TZX5469Z6I) 20 mg in 100 mL
CYSTEINE HYDROCHLORIDE (UNII: ZT934N0X4W) 10 mg in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHOSPHORIC ACID (UNII: E4GA8884NN)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:70510-2171-2 2 in 1 CARTON 05/05/2017
1 NDC:70510-2171-1 100 mL in 1 BAG; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209176 05/05/2017
LABELER - MT PHARMA AMERICA, INC. (080161422)
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