injection
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
12-12-2017
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Active ingredient:
ECULIZUMAB (UNII: A3ULP0F556) (ECULIZUMAB - UNII:A3ULP0F556)
Available from:
Food and Drug Administration
Authorization status:
Biologic Licensing Application
Summary of Product characteristics
Food and Drug Administration
INDEXING - PRODUCT CONCEPT
- ECULIZUMAB INJECTION
FOOD AND DRUG ADMINISTRATION
REFERENCE LABEL SET ID: EBCD67FA-B4D1-4A22-B33D-EE8BF6B9C722
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ABSTRACT PRODUCT CONCEPT
injection
PRODUCT INFORMATION
PRODUCT T YPE
INDEXING - PRODUCT CONCEPT
ITE M CODE (SOURCE )
16 f3f311-ff6 d-6 6 0 1-9 332-b56 70 50 0 35b0
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ECULIZUMAB (UNII: A3ULP0 F556 ) (ECULIZUMAB - UNII:A3ULP0 F556 )
ECULIZUMAB
30 0 mg in 30 mL
APPLICATION PRODUCT CONCEPT
PRODUCT INFORMATION
PRODUCT T YPE
INDEXING - PRODUCT CONCEPT
ITE M CODE (SOURCE )
10 6 18 da e -d9 24-b570 -0 41e -c fb26 df9 26 3c
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
BLA
BLA12516 6
LABELER -
Food and Drug Administration (927645523)
Revised: 12/2017
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