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.