Is Prasugrel registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Prasugrel, including PLATEREL 10MG F.C.TABLET (10 mg, Film-coated tablet, SAR 175.00); PLATEREL 5MG F.C.TABLET (5 mg, Film-coated tablet, SAR 175.00); Pevas (5 mg, Film-coated tablet, SAR 157.50); Pevas (10 mg, Film-coated tablet, SAR 157.50).

Is Prasugrel approved by the US FDA?

Drugs@FDA lists 11 application product lines for Prasugrel, including EFFIENT (Prescription); PRASUGREL (Prescription); PRASUGREL (Prescription); PRASUGREL (Prescription); PRASUGREL (Prescription).

Is Prasugrel authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Prasugrel: Efient, Prasugrel Viatris (previously Prasugrel Mylan).

Are there safety signals or safety updates for Prasugrel?

EMA PRAC: 4 entries; US FDA: 1 entry; MHRA: 2 entries (latest 2020-12-22).

Active substance

Prasugrel

SFDA 4
US FDA 11
EMA 2
Health Canada 1
US price lines 2
NHS prices 2
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PLATEREL 10MG F.C.TABLET	10 mg	Film-coated tablet · Oral use	30 Bottle	SAR 175.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
PLATEREL 5MG F.C.TABLET	5 mg	Film-coated tablet · Oral use	30 Bottle	SAR 175.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Pevas	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 157.50	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Pevas	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 157.50	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid

Indications — CHI Daman Drug Formulary

CORONARY ARTERY DISEASE; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)

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

Product	Strength	Form · route	Applicant	Status	First approved
EFFIENT	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	COSETTE	Prescription	10 Jul 2009
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	MYLAN	Prescription	12 Jul 2017
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	AUROBINDO PHARMA	Prescription	16 Oct 2017
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	PANACEA	Prescription	16 Oct 2017
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	ACCORD HLTHCARE	Prescription	2 Feb 2018
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	HEC PHARM	Prescription	16 Jan 2019
PRASUGREL HYDROCHLORIDE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	UNICHEM	Prescription	28 Aug 2023
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	CHARTWELL RX	Discontinued	16 Oct 2017
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	AMNEAL PHARMS	Discontinued	19 Jun 2018
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	SENORES PHARMS	Discontinued	7 Jul 2020
PRASUGREL	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	LUPIN	Discontinued	9 Jan 2023

EMA European Union — centrally authorised medicines

Efient Substipharm · Authorised · authorised 24 Feb 2009 · ATC B01AC22

Therapeutic indication (EMA)

Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).

Prasugrel Viatris (previously Prasugrel Mylan) Viatris Limited · Authorised · authorised 15 May 2018 · ATC B01AC22

Therapeutic indication (EMA)

Prasugrel Viatris, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAMP PRASUGREL	02502429	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PRASUGREL 10 MG TABLET	$0.26297	per EA	23 Sep 2026
US NADAC	PRASUGREL 5 MG TABLET	$0.25924	per EA	23 Sep 2026
NHS Drug Tariff	Prasugrel 10mg tablets	£2.86	28 tablet	1 Oct 2026
NHS Drug Tariff	Prasugrel 5mg tablets	£6.52	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 22 Dec 2020 EFFIENT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 16 Jan 2020 PRAC signal: Severe cutaneous adverse reactions (SCARs)
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2019 PRAC signal: Severe cutaneous adverse reactions (SCARs)
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2015 PRAC signal: Safety of dual antiplatelet therapy
Action for MAH: update of the product information: No
EMA PRAC 9 Jan 2015 PRAC signal: Safety of dual antiplatelet therapy
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Prasugrel (Efient): increased risk of bleeding
New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST segment elevation myocardial infarction.
MHRA 11 Dec 2014 Prasugrel (Efient▼): rare but serious hypersensitivity reactions
Healthcare professionals should be aware of this risk when prescribing prasugrel.

All safety entries for prasugrel →

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.