VARUBY Film-coated tablet Ref.[7569] Active ingredients: Rolapitant

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: TESARO Bio Netherlands B.V., Joop Geesinkweg 901, 1114 AB Amsterdam-Duivendrecht, Netherlands

Product name and form

Varuby 90 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Tablets are blue, debossed with T0101 on one side and 100 on the other.

Qualitative and quantitative composition

Each tablet contains 90 mg of rolapitant (as hydrochloride monohydrate).

Excipient(s) with known effect: This medicinal product contains 230 mg of lactose (as monohydrate) per dose (two tablets).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rolapitant

Rolapitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
List of Excipients

Tablet content:

Lactose monohydrate
Pregelatinised starch
Microcrystalline cellulose (E460)
Povidone (K-30)
Croscarmellose sodium
Colloidal silicon dioxide
Magnesium stearate

Tablet coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol
Talc
Indigo carmine (E132)
Polysorbate 80

Pack sizes and marketing

Polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.

Pack size of two tablets.

Marketing authorization holder

TESARO Bio Netherlands B.V., Joop Geesinkweg 901, 1114 AB Amsterdam-Duivendrecht, Netherlands

Marketing authorization dates and numbers

EU/1/17/1180/001

Date of first authorisation: 20 April 2017

 
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