LAGEVRIO Hard capsule Ref.[27931] Active ingredients: Molnupiravir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, United Kingdom

Product name and form

Lagevrio 200 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Swedish Orange, opaque, size 0 (approximately 21.7 mm x 7.6 mm) hard capsule, printed with MSD corporate logo on the cap and “82” on the body in white ink.

Qualitative and quantitative composition

Each hard capsule contains 200 mg of molnupiravir.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Molnupiravir

Molnupiravir is indicated for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness. Molnupiravir is a prodrug that is metabolised to the ribonucleoside analogue N-hydroxycytidine (NHC) which distributes into cells where it is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP).

List of Excipients

Capsule content:

Croscarmellose sodium (E468)
Hydroxypropyl cellulose (E463)
Magnesium stearate (E470b)
Microcrystalline cellulose (E460)

Capsule shell:

Hypromellose (E464)
Titanium dioxide (E171)
Red iron oxide (E172)

Printing ink:

Butyl alcohol
Dehydrated alcohol
Isopropyl alcohol
Potassium hydroxide
Propylene glycol (E1520)
Purified water
Shellac
Strong ammonia solution
Titanium dioxide (E171)

Pack sizes and marketing

High-density polyethylene (HDPE) bottles with a polypropylene closure containing 40 capsules.

Marketing authorization holder

Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, United Kingdom

Marketing authorization dates and numbers

PLGB 53095/0089

Date of first authorisation: 4th November 2021

Drugs

Drug Countries
LAGEVRIO Japan, New Zealand, Romania, United Kingdom, United States

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