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MedsAcross

Molecule

Prasugrel

Also known as prasugrel hydrochloride
Available on requestOrphanHaematology
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

Prasugrel is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI). MedsAcross supplies Prasugrel for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
P2Y12 Platelet Inhibitor, P2Y12 Receptor Antagonists, Decreased Platelet Aggregation
ATC classification
B01AC22 Prasugrel · Antithrombotic, subgroup B01AC
US FDA first approval
10 July 2009
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 34K66TBT99RxCUI 613391CAS 150322-43-3DrugBank DB06209Q416232

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Effient is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI.

Source: US FDA prescribing information

How it works

Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y 12 class of ADP receptors on platelets.

Source: US FDA prescribing information

Dosing overview

Initiate Effient treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily. Patients taking Effient should also take aspirin (75 mg to 325 mg) daily. Effient may be administered with or without food. Initiate treatment with a single 60 mg oral loading dose. Continue at 10 mg once daily with or without food. Consider 5 mg once daily for patients <60 kg. Patients should also take aspirin (75 mg to 325 mg) daily. Timing of Loading Dose In the clinical trial that established the efficacy and safety of Effient, the loading dose of Effient was not administered until coronary anatomy was established in UA/NSTEMI patients and in STEMI patients presenting more than 12 hours after symptom onset.

Source: US FDA prescribing information

Contraindications

Active pathological bleeding. Prior transient ischemic attack or stroke. Hypersensitivity to prasugrel or any component of the product

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (bleeding risk): Effient can cause significant, sometimes fatal, bleeding. Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack (TIA) or stroke. CABG-related bleeding: Risk increases in patients receiving Effient who undergo CABG. Discontinuation of Effient: Premature discontinuation increases risk of stent thrombosis, MI, and death. Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with Effient. Hypersensitivity: Hypersensitivity including angioedema has been reported with Effient including in patients with a history of hypersensitivity reaction to other thienopyridines.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are also discussed elsewhere in the labeling: Bleeding Thrombotic Thrombocytopenic Purpura Hypersensitivity Including Angioedema Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction.

Source: US FDA prescribing information

Interactions

Opioids: Decreased exposure to prasugrel. Consider use of parenteral antiplatelet agent. Warfarin Coadministration of Effient and warfarin increases the risk of bleeding.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Prasugrel, sorted by availability.

MedicineManufacturerRegisterAvailability
Prasugrel 10 mg tabletOralGeneric name—US FDAAvailable on request
Prasugrel 5 mg tabletOralGeneric name—US FDAAvailable on request
Effient 10 mg tabletOralCosette PharmaceuticalsUS FDAAvailable on request
Effient 5 mg tabletOralCosette PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 10 July 2009Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Prasugrel in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Prasugrel available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Prasugrel and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Prasugrel have?

The catalogue lists 1 brand names for Prasugrel, including Effient.

Is Prasugrel approved by the US FDA?

Yes. The US FDA first approved Prasugrel on 10 July 2009, according to Drugs@FDA.

Is Prasugrel authorised in the European Union?

Yes. Prasugrel has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Prasugrel need cold chain shipping?

No listed presentation of Prasugrel is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Prasugrel in?

Prasugrel is classified under ATC code B01AC22 (Prasugrel).

References

  1. Effient prescribing information (Cosette Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 7 September 2022
  2. Efient: European public assessment report (EPAR). European Medicines Agency. Retrieved 13 November 2025
  3. Prasugrel Viatris (previously Prasugrel Mylan): European public assessment report (EPAR). European Medicines Agency. Retrieved 2 September 2026

Request Prasugrel for export supply

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