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1060051
star this property registered interest false more like this
star this property date less than 2019-02-12more like thismore than 2019-02-12
star this property answering body
Department of Health and Social Care more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Blood: Medical Treatments more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, what steps he is taking to make immunoglobulin therapy available for the treatment of Mast Cell Activation Syndrome. more like this
star this property tabling member constituency Harborough more like this
star this property tabling member printed
Neil O'Brien more like this
star this property uin 220333 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2019-02-20more like thismore than 2019-02-20
star this property answer text <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>
star this property answering member constituency Thurrock more like this
star this property answering member printed Jackie Doyle-Price more like this
star this property question first answered
remove filter
star this property answering member
4065
star this property label Biography information for Jackie Doyle-Price more like this
unstar this property tabling member
4679
unstar this property label Biography information for Neil O'Brien more like this