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PROMACTA KIT (nda207027)- (EQ 25MG ACID/PACKET,EQ 12.5MG ACID/PACKET)

ELTROMBOPAG OLAMINE NOVARTIS
EQ 25MG ACID/PACKET,EQ 12.5MG ACID/PACKET
Yes No
2026-Jan-13 Expired
2015-Nov-20 None
None No
PROMACTA is a thrombopoietin receptor agonist indicated: • for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. • for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferonbased therapy or limits the ability to maintain interferon-based therapy. • in combination with standard immunosuppressive therapy for the firstline treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. • for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
1 0 0
Total Other Developers None
Drugs with Suitability No
EQ 25MG ACID/PACKET ** ** - - -
EQ 12.5MG ACID/PACKET ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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