To Marketing Authorisation Holders and their agents

Regarding medicinal shortages

17.7.2019

Doloproct (flucortolone) rectal suppositories, a medicinal product marketed and sold in Iceland has been out of stock at wholesale level for some time due to transfer of the marketing authorisation. The product will not be available again. Doloproct (flucortolone) rectal suppositories is used for symptomatic treatment of pain, inflammation, burning and itching associated with hemorroids, anal fissures and pruritus ani. 

It is the only medicinal product that is marketed in Iceland with the before mentioned indication and pharmaceutical form. An unregistered product is currently available on exemption. It is important to ensure a constant and steady supply of medicinal products for patients in Iceland and reduce the number of products used on exemption.

IMA encourages Marketing Authorisation Holders and their agents to act if they have a medicinal product available with the before mentioned characteristics. There is a need and great demand for such a product. 

Doloproct (flucortolone) suppositories sales in 2018 was 11,745 units.

Medicinal products that have been granted a marketing authorisation in Iceland can be marketed on the basis of approved price, as well as the availability of Icelandic texts.
For medicinal products that do not have an Icelandic marketing authorisation IMA draws attention to a simplified procedure, the zero day procedure that was established to increase the number of marketed medicinal products in Iceland.