Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
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Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

Prasugrel hydrochloride

CAS No.

389574-19-0

Innovator/marketer

Efient

Polymorphic form

Form B2

Therapeutic Area

Cardiovascular system

Status

Commercial

EU DMF readiness

US DMF readiness

030765

Drug description:

Prasugrel hydrochloride is an anti-platelet agent.
It 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).
It is formulated as tablets and film-coated tablets for oral route of administration.

Mechanism of action:

Prasugrel is a P2Y purinoceptor 12 (P2Y12) inhibitor. It acts through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. This impairs the ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. This causes inactivation of platelets and blocks blood clotting.

DISCLAIMER
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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