DOPTELET Film-coated tablet Ref.[27846] Active ingredients: Avatrombopag

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden

Product name and form

Doptelet 20 mg film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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.

Active Ingredient Description

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.

List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose (E460(i))
Crospovidone type B (E1202)
Silica, colloidal anhydrous (E551)
Magnesium stearate (E470b)

Film coating:

Poly(vinyl alcohol) (E1203)
Talc (E553b)
Macrogol 3350 (E1521)
Titanium dioxide (E171)
Iron oxide yellow (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden

Marketing authorization dates and numbers


Date of first authorisation: 20 June 2019


Drug Countries
DOPTELET Austria, Estonia, Spain, Finland, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom, United States

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