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ACTILYSE
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Opinions on drugs -
Posted on
Jul 04 2012
- Updated on
Jul 25 2012
Reason for request
Inclusion on the list of medicines approved for hospital use in the new indication: “Fibrinolytic treatment of acute ischaemic stroke within 4.5 hours after onset of symptoms”, as opposed to within 3 hours in the previous indication.
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Clinical Benefit
| Substantial |
The actual benefit of ACTILYSE is substantial in the new indication. |
Clinical Added Value
| moderate |
Given the absence of long-term efficacy data, the low level of quantity of effect of alteplase versus placebo and the risk of intracranial haemorrhage, ACTILYSE provides a moderate improvement in actual benefit (IAB III) in the treatment of ischaemic stroke in the extension of the treatment window (0 - 4.5 h instead of 0 - 3 h) following the onset of stroke symptoms. |
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