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prasugrel

Efient · ATC code B01AC22

Brand names: Efient, Prasugrel Hcs, Prasugrel Ratiopharm, Prasulan, Prafsia, Prasillt, Prasugrel Accord, Prasugrel Al, Prasugrel Beta, Prasugrel Heumann, Prasugrel Puren, Prasugrel Vivanta, Prasugrel Zentiva, Prasugrelhydrobromid Zentiva, Ugramel …

Key facts
Active substance
prasugrel
Drug class
Antithrombotic
ATC code
B01AC22
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Efient 10 mg film-coated tablets. / Efient 5 mg film-coated tablets.
Marketing authorisation holder
Substipharm
Information as of
2026-10-27

Key facts

Prasugrel (Efient) is a platelet aggregation inhibitor (P2Y12 inhibitor). Co-administered with acetylsalicylic acid, it prevents atherothrombotic events in acute coronary syndrome managed with percutaneous coronary intervention (PCI).

What it is used for

  • Prevention of atherothrombotic events in adults with acute coronary syndrome (unstable angina/NSTEMI or STEMI) undergoing primary or delayed PCI, together with ASA

Dosing

  • Single 60 mg loading dose, then 10 mg once a day, with daily ASA (75 mg to 325 mg)
  • UA/NSTEMI with coronary angiography within 48 hours of admission: loading dose only at the time of PCI
  • Body weight < 60 kg: after the 60 mg loading dose, 5 mg once daily; 10 mg not recommended
  • Patients ≥ 75 years: generally not recommended; if deemed necessary, 5 mg maintenance after a 60 mg loading dose
  • Treatment of up to 12 months recommended; premature discontinuation increases the risk of thrombosis, myocardial infarction or death
  • No dose adjustment in renal impairment or mild to moderate hepatic impairment

Contraindications

  • Active pathological bleeding
  • History of stroke or transient ischaemic attack (TIA)
  • Severe hepatic impairment (Child Pugh class C)
  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Increased risk of major and minor bleeding, especially at age ≥ 75 years, body weight < 60 kg, bleeding propensity or concomitant drugs that increase bleeding
  • Discontinue at least 7 days before elective surgery if an antiplatelet effect is not desired; more bleeding with CABG within 7 days of stopping
  • Hypersensitivity reactions including angioedema, also in patients with prior clopidogrel hypersensitivity
  • Thrombotic thrombocytopenic purpura (TTP) has been reported

Side effects

  • Bleeding is the most common adverse reaction; the gastrointestinal tract is the most common site of spontaneous bleeding, the arterial puncture site of provoked bleeding
  • Serious: life-threatening and fatal bleeding, angioedema, TTP

Interactions

  • Warfarin or other coumarins: increased bleeding risk, use with caution
  • Chronic NSAIDs (including COX-2 inhibitors): increased bleeding risk, use with caution
  • Morphine and other opioids: delayed and decreased exposure, reduced efficacy
  • Other agents increasing bleeding risk: oral anticoagulants, clopidogrel, fibrinolytics

Pregnancy and breastfeeding

  • No clinical studies; use in pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus
  • Use during breastfeeding is not recommended

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Prasugrel HcsHcs Bvba · 1 register entry
  • Prasugrel RatiopharmTeva B.V · 1 register entry
  • PrasulanG.L. Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • PrafsiaPharmathen S.A. · 1 register entry
  • PrasilltTad Pharma Gmbh · 1 register entry
  • Prasugrel AccordAccord Healthcare B.V. · 1 register entry
  • Prasugrel AlAliud Pharma Gmbh · 1 register entry
  • Prasugrel BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Prasugrel HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Prasugrel PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Prasugrel RatiopharmRatiopharm Gmbh · 1 register entry
  • Prasugrel VivantaVivanta Generics S.R.O. · 1 register entry
  • Prasugrel ZentivaZentiva Pharma Gmbh · 1 register entry
  • Prasugrelhydrobromid ZentivaZentiva Pharma Gmbh · 2 register entries
  • UgramelZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • EffientER-KİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • SugvidaCELTİS İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 24 more European countries
Belgium
Prasugrel Krka
Bulgaria
Eлискардиа, Бевим, Празугрел Тева, Тозинал, Флуидоро
Croatia
Eliskardia, Prasugrel Pliva, Tosynal
Czechia
Eliskardia
Denmark
Prafsia, Prasugrel Eql Pharma, Prasugrel G.L. Pharma, Prasugrel Krka
Estonia
Eliskardia, Prasugrel Alembic
France
Prafsia, Prasugrel Arrow, Prasugrel Bgr, Prasugrel Cristers, Prasugrel Eg, Prasugrel Krka, Prasugrel Teva, Prasugrel Zentiva, Prasugrel Zydus
Greece
Prafsia, Prasugrel Vocate
Hungary
Bewim, Eliskardia
Iceland
Efient, Prasugrel G.L. Pharma, Prasugrel Krka, Prasugrel Viatris
Ireland
Prasugrel Accord, Prasugrel Krka
Italy
Drullub, Prafsia, Prasugrel Teva
Liechtenstein
Efient, Prasugrel Viatris
Lithuania
Eliskardia
Malta
Prasugrel Vocate
Netherlands
Prasugrel Ratiopharm, Prasugrel Teva, Prasugrel Vivanta
Norway
Efient, Prasugrel Eql Pharma, Prasugrel Krka, Prasugrel Viatris
Poland
Bewim, Sigrada, Ugramel
Portugal
Prasugrel Pentafarma, Prasugrel Tecnigen, Prasugrel Vivanta
Romania
Eliskardia
Slovakia
Bewim, Sigrada
Slovenia
Eliskardia, Tosynal
Spain
Prafsia, Prasugrel Combix, Prasugrel Krka, Prasugrel Qualigen, Prasugrel Stadafarma, Prasugrel Teva, Prasugrel Vivanta
Sweden
Prasugrel Eql Pharma, Prasugrel G.L. Pharma, Prasugrel Krka

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Efient – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/efient-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC B01AC.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.