When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
4. Clinical particulars
4.8 Undesirable effects
CABG-related bleeding
Added (bold) Deleted (strikethrough):
For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.34% (3 of 90 89 patients) in the clopidogrel group. Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacodynamics
Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (129%) and within-subject (912%) variability with both 5 µM and 20 µM ADP.
6. PHARMACEUTICAL PARTICULARS
6.5 Nature and contents of container
Added (bold):
Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Not all pack sizes may be marketed.
8. MARKETING AUTHORISATION NUMBER(S)
Added:
EU/1/08/503/015 Efient 5mg - 30 film-coated tablet
EU/1/08/503/016 Efient 10mg - 30 film-coated tablet
10. DATE OF REVISION OF THE TEXT
21 September 2009
Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
18 May 2009
First SPC for new product.
25 February 2009