Decision

Alteplase for treatment of acute ischaemic stroke: independent review

The review of alteplase in the treatment of acute ischaemic stroke by the expert working group of the Commission on Human Medicines.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 July 2015

Documents

Summary of the review

PDF, 306 KB, 44 pages

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Background and regulatory overview

PDF, 482 KB, 28 pages

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Evolution of stroke care and uptake of alteplase in the UK

PDF, 1.23 MB, 52 pages

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Concerns on the evidence

PDF, 2.37 MB, 162 pages

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Benefit and risk of alteplase and clinical use

PDF, 3.54 MB, 179 pages

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Communication of benefit and risk with patients

PDF, 5.15 MB, 113 pages

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Draft conclusions and recommendations of the expert working group to CHM

PDF, 463 KB, 37 pages

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Final conclusions and recommendations

PDF, 3 MB, 271 pages

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Commission on Human Medicines: alteplase expert working group agendas and minutes

PDF, 318 KB, 29 pages

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Details

The Commission on Human Medicines (CHM) has fully endorsed the conclusions and recommendations of the expert working group on alteplase in the treatment of stroke, confirming that the benefit of alteplase outweighs the risk when used up to 4.5 hours after symptoms appear.

The commission supported full transparency and the publication of all information considered by the group. Some information has been redacted to protect the identity of individuals and details of unpublished data.

The group considered the data above to reach their conclusions.

See the summary of product characteristics (SPC) and the patient information leaflet (PIL) for more details on alteplase.

Published 24 July 2015