Regulatory PathRegulatory requirements compared

Active substance

Naloxegol

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
MOVANTIKEQ 12.5MG BASE; EQ 25MG BASEtablet · oralAVERITASPrescription16 Sep 2014

EMA European Union — centrally authorised medicines

Moventig Grunenthal GmbH · Authorised · authorised 7 Dec 2014 · ATC A06AH03

Therapeutic indication (EMA)

Treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MOVANTIK0244216712.5 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
MOVANTIK0244217525 MGTABLET · ORALKNIGHT THERAPEUTICS INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMOVANTIK 12.5 MG TABLET$14.59872per EA23 Sep 2026
US NADACMOVANTIK 25 MG TABLET$14.61317per EA23 Sep 2026
NHS Drug TariffNaloxegol 12.5mg tablets£55.2030 tablet1 Oct 2026
NHS Drug TariffNaloxegol 25mg tablets£55.2030 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 13 Apr 2020 MOVANTIK — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for naloxegol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.