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news.Sanofi-Aventis and Bristol-Myers Squibb have said that the Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion recommending approval of the 300mg tablet of the antiplatelet Plavix.
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This positive opinion from the CHMP needs to be ratified by the European Commission in the coming months before final approval.
The new 300mg tablet will facilitate the use of the approved loading dose of Plavix and the early initiation as recommended by national and international guidelines in appropriate patients with acute coronary syndrome (ACS); including those with unstable angina or non-ST segment elevation myocardial infarction and ST segment elevation myocardial infarction patients. The 300mg tablet is bioequivalent to four 75mg tablets of Plavix.