Magistral preparation of red morphine drops

The Danish Medicines Agency has reviewed relevant available literature and not seen any documentation that there is a significant difference in the therapeutic efficacy of magistral red morphine drops and the marketed medicinal product Oramorph, oral drops and oral solution – regardless of any difference in the strength of the medicinal products. This means that as from 3 December 2016 pharmacies are no longer permitted to prepare red morphine drops, unless they have a permission from the Danish Medicines Agency.

Permission in special cases

If, in a special case, a doctor needs to prescribe a magistral preparation of red morphine drops, the doctor must apply for permission from the Danish Medicines Agency so that the pharmacy can prepare red morphine drops for the individual patient.

The application must include a reason why the patient cannot use the marketed medicinal product Oramorph, oral drops and oral solution. The permission must be presented at the pharmacy every time the patient asks the pharmacy to accept the prescription for the magistral medicine.