Subject Predicate Object
nIppi0p0
a
Resource
Answer
Written answer
answer has question
Bd802nBj
answer has answering person
Norman Peter Lamb
answer text
<p>On 12 November 2013 following earlier consideration of the matter by its independent expert advisory group, the Commission on Human Medicines (CHM) the MHRA published advice in relation to switching between manufacturers' products of oral antiepileptic drugs (AEDs). This advice included messages targeted to health care professionals, patients and marketing authorisation holders.</p><p>Furthermore, information setting the context of this advice in relation to National Institute for Health and Care Excellence (NICE) guidance on AEDs and the regulatory approval of generic drugs was also provided.</p><p>On 25 November 2013 the Medicines and Healthcare products Regulatory Agency (MHRA) published more detailed information in the form of a report of the evidence which was considered by the CHM in reaching this position. This report can be found on the MHRA website:</p><p>www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con341226.pdf</p><p>The review considered adverse drug reaction (ADR) reporting, published literature and the characteristics of the individual AEDs, their therapeutic index, solubility and absorption properties. With regard to the characteristics of the individual drugs, a summary for each drug is included within the CHM report.</p><p>ADR reports will continue to be monitored, along with any other emerging evidence, and if the strength of evidence supports it then re-categorising a particular drug substance would be considered.</p><p>A list of the published literature reviewed as part of this process will also shortly be published alongside the already available information.</p>
answer given date
answer has answering body
Department of Health
written answer has answering body
Department of Health
Department of Health
answering body has written answer
nIppi0p0
answering body has answer
nIppi0p0
Bd802nBj
question has answer
nIppi0p0
Norman Peter Lamb
answering person has answer
nIppi0p0