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.
Myocet is available in cartons containing 1 set or 2 sets of the three constituents. Not all pack-sizes may be marketed.
Update of section 4.4 of the SmPC (Special warnings and Precautions for use) to include: Radiation recall post-marketing PV cases and Results from 2 meta-analysis conducted on the 2 pivotal studies (Batist 2001 and Harris 2002): the Cochrane meta-analysis of Van Dalen 2010 and the cardiac analysis in sub-group of anthracycline pretreated patients of Batist 2006;
Deletion of the term "egg" for the excipient "egg phosphatidylcholine", which was confusing for patients allergic to egg (SmPC sec. 6.1, PIL sec. 6, outer carton, inner carton);
sections 2, 3, 4.1, 4.2, 4.5, 4.6, 4.8, 5.1, 6.3, 6.4, 6.5, 6.6 and 9 of the SmPC that have been updated, mainly to align the SmPC to the European Quality Review of Documents template on how to present the SmPC, Labelling and Package Leaflet. Additional information: section 4.2 - add info on paedriatric population; method of administration section 4.6 - info on women of childbearing potential
'The cardiac function of the patients treated concomitantly with Myocet and trastuzumab must be appropriately monitored as described below.'
Cephalon Europe
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