A positive scientific opinion is not a recommendation for use of the medicine and should not be interpreted as such. As such, this is a scientific opinion and should not be regarded as a medicine licensed by the MHRA or a future commitment by the MHRA to license such a medicine, nor should it be regarded as an authorisation to sell or supply such a medicine. The scientific opinion is based on assessment of the information supplied to the MHRA on the benefits and risks of this promising new medicine. Guidance on prescribing unlicensed medicines can be found on the GMC webpage. This medicine does not yet have a licence (marketing authorisation) and the information is provided to assist physicians in prescribing this unlicensed medicine. This information is intended for healthcare professionals and is provided by the pharmaceutical company that manufactures the EAMS medicine. The medicinal products included in the scheme are those that are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options. The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed medicines and medicines used outside their licence, to UK patients that have a high unmet clinical need. Early Access to Medicines Scheme – Treatment protocol – Information for healthcare professionals Introduction
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