Source: European Medicines Agency (EU) | Revision Year: 2021 | Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Doptelet 20 mg film-coated tablets.
Film-coated tablet (tablet).
Pale yellow, round biconvex film-coated 7.6 mm tablet debossed with “AVA” on one side and “20” on the other.
Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg of avatrombopag.
Excipient with known effect: Each film-coated tablet contains 120.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
Avatrombopag is an orally active, small molecule thrombopoietin (TPO) receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in increased production of platelets. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.
Microcrystalline cellulose (E460(i))
Crospovidone type B (E1202)
Silica, colloidal anhydrous (E551)
Magnesium stearate (E470b)
Poly(vinyl alcohol) (E1203)
Macrogol 3350 (E1521)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Blister (polyamide and polyvinyl chloride-laminated aluminium film with push-through aluminium and polyethylene terephthalate foil) containing either 10 or 15 film-coated tablets. Each carton contains one blister of 10 or 15 film-coated tablets or two blisters of 15 film-coated tablets.
Not all pack sizes may be marketed.
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Date of first authorisation: 20 June 2019
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.