MULPLEO Film-coated tablet Ref.[7587] Active ingredients: Lusutrombopag

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Shionogi B.V., Kingsfordweg 151, 1043GR, Amsterdam, The Netherlands

Product name and form

Mulpleo 3 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Light red, 7.0 mm round film-coated tablets debossed with the Shionogi trademark above the identifier code “551” on one side and debossed on the other side with the strength “3”.

Qualitative and quantitative composition

Each film-coated tablet contains 3 mg of lusutrombopag.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lusutrombopag

Lusutrombopag is an orally active TPO receptor agonist. Lusutrombopag acts on the haematopoietic stem cells and on the transmembrane domain of human TPO receptors expressed in megakaryocytes, to stimulate the megakaryocyte to proliferate and differentiate via the similar signal transduction pathway for up-regulating production used by endogenous TPO, thus leading to thrombocytopoiesis.

List of Excipients

Tablet core:

Mannitol
Microcrystalline cellulose
Magnesium oxide
Sodium lauryl sulfate
Hydroxypropylcellulose
Carmellose calcium
Magnesium stearate

Film-coating:

Hypromellose
Titanium dioxide
Triethyl citrate
Talc
Red ferric oxide (E172)

Pack sizes and marketing

OPA/Aluminium foil/PVC film blister with push through aluminium lidding foil, packed in a cardboard box. Each box contains 7 film-coated tablets.

Marketing authorization holder

Shionogi B.V., Kingsfordweg 151, 1043GR, Amsterdam, The Netherlands

Marketing authorization dates and numbers

EU/1/18/1348

02/2019

Drugs

Drug Countries
MULPLEO Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom

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