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<p>Immunoglobulins are not currently licensed for the treatment of Mast Cell Activation
Syndrome (MCAS). However, immunoglobulin therapy may be used ‘off-label’, if there
are no other alternative licensed products available and the physician considers that
immunoglobin therapy is appropriate to address the clinical need in order to manage
a patient with MCAS. This decision, under the full responsibility of the physician,
will need to be made following discussion between the physician and the patient.</p><p>
</p><p>In order to gain a licence for the use of immunoglobulin therapy for the treatment
of MCAS, a Marketing Authorisation Holder would have to submit a variation to their
Marketing Authorisation to the Medicines and Healthcare products Regulatory Agency
(MHRA) with a dossier compiled of safety and efficacy data. Specialist assessors would
review the dossier and a variation to the Marketing Authorisation would only be granted
if it is determined that the benefits of the product outweigh any potential risks
of using the product in its proposed indication.</p><p> </p><p>The MHRA provides a
scientific advice service to Marketing Authorisation Holders regarding their submissions
should they request it.</p>
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