Is Prucalopride registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Prucalopride, including Altan (1 mg, Film-coated tablet, SAR 98.40); Altan (2 mg, Film-coated tablet, SAR 161.75); Conestal (1 mg, Film-coated tablet, SAR 85.30); Conestal (2 mg, Film-coated tablet, SAR 140.20); RESOLOR 1 mg film-coated tablet (1 mg, Film-coated tablet, SAR 98.40).

Is Prucalopride approved by the US FDA?

Drugs@FDA lists 20 application product lines for Prucalopride, including MOTEGRITY (Prescription); PRUCALOPRIDE SUCCINATE (Prescription); PRUCALOPRIDE SUCCINATE (Prescription); PRUCALOPRIDE SUCCINATE (Prescription); PRUCALOPRIDE SUCCINATE (Prescription).

Is Prucalopride authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Prucalopride: Resolor.

Are there safety signals or safety updates for Prucalopride?

US FDA: 1 entry (latest 2025-07-10).

Active substance

Prucalopride

SFDA 7
US FDA 20
EMA 1
Health Canada 10
US price lines 4
NHS prices 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Altan	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 98.40	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Altan	2 mg	Film-coated tablet · Oral use	30 Blister	SAR 161.75	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Altan	2 mg	Film-coated tablet · Oral use	30 Blister	SAR 161.75	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Conestal	1 mg	Film-coated tablet · Oral use	28 Blister	SAR 85.30	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
Conestal	2 mg	Film-coated tablet · Oral use	28 Blister	SAR 140.20	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
RESOLOR 1 mg film-coated tablet	1 mg	Film-coated tablet · Oral use	28 Blister	SAR 98.40	NCE · Prescription	Amdipharm Mercury (Australia) Pty Limited	Valid
RESOLOR 2 mg film-coated tablet	2 mg	Film-coated tablet · Oral use	28 Blister	SAR 161.75	NCE · Prescription	Amdipharm Mercury (Australia) Pty Limited	Valid

Indications — CHI Daman Drug Formulary

CONSTIPATION; IRRITABLE BOWEL SYNDROME

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

Product	Strength	Form · route	Applicant	Status	First approved
MOTEGRITY	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	TAKEDA PHARMS USA	Prescription	14 Dec 2018
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	NOVITIUM PHARMA	Prescription	26 Dec 2024
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	HIKMA PHARMS	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	MSN	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	ALKEM LABS LTD	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	ZENARA	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	AMNEAL	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	LUPIN	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	APPCO	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	APOTEX	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	SOMERSET THERAP	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	ANNORA PHARMA	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	SPECGX LLC	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	BIONPHARMA	Prescription	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	ZYDUS LIFESCIENCES	Prescription	7 Aug 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	AJANTA PHARMA LTD	Prescription	16 Jan 2026
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	MICRO LABS	Prescription	29 Jun 2026
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	ALEMBIC	Prescription	27 Jul 2026
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	TORRENT	Discontinued	24 Jun 2025
PRUCALOPRIDE SUCCINATE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	TEVA PHARMS INC	Discontinued	5 Feb 2026

EMA European Union — centrally authorised medicines

Resolor Takeda Pharmaceuticals International AG Ireland · Authorised · authorised 14 Oct 2009 · ATC A06AX05

Therapeutic indication (EMA)

Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-PRUCALOPRIDE	02491591	1 MG	TABLET · ORAL	APOTEX INC
APO-PRUCALOPRIDE	02491605	2 MG	TABLET · ORAL	APOTEX INC
JAMP PRUCALOPRIDE	02493489	1 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP PRUCALOPRIDE	02493497	2 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
NRA-PRUCALOPRIDE	02550377	1 MG	TABLET · ORAL	NORA PHARMA INC
NRA-PRUCALOPRIDE	02550385	2 MG	TABLET · ORAL	NORA PHARMA INC
PRUCALOPRIDE	02559005	1 MG	TABLET · ORAL	SANIS HEALTH INC
PRUCALOPRIDE	02559013	2 MG	TABLET · ORAL	SANIS HEALTH INC
RESOTRAN	02377012	1 MG	TABLET · ORAL	AMDIPHARM LIMITED
RESOTRAN	02377020	2 MG	TABLET · ORAL	AMDIPHARM LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MOTEGRITY 1 MG TABLET	$17.73123	per EA	23 Sep 2026
US NADAC	MOTEGRITY 2 MG TABLET	$17.75118	per EA	23 Sep 2026
US NADAC	PRUCALOPRIDE 1 MG TABLET	$0.63933	per EA	23 Sep 2026
US NADAC	PRUCALOPRIDE 2 MG TABLET	$0.61897	per EA	23 Sep 2026
NHS Drug Tariff	Prucalopride 1mg tablets	£5.12	28 tablet	1 Oct 2026
NHS Drug Tariff	Prucalopride 2mg tablets	£6.10	28 tablet	1 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 10 Jul 2025 MOTEGRITY — 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 prucalopride →

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.