Marketing Authorisation for Hydrocortisone and Fludrocortisone acetate

17 June 2020

Ace has received a Marketing Authorisation for her Hydrocortisone and Fludrocortisone acetate tablets. With our products, Ace provides patients with adrenal insufficiency a licensed alternative for previously compounded tablets.

The coloured filmcoated tablets of 1 mg, 5 mg and 10 mg Hydrocortisone are branded as Acecort®. Unique is the combination pack that contains 4 blister strips: each strip provides patients with their standard dosage of 10 mg and 5 mg tablets per intake for a full week. The coloured coating of the Acecort tablets corresponds with the Dutch standard* that was already common practice for the compounded products.

Fludrocortisone acetate 62.5 microgram tablets are available under the brand name Fludrace®. These tablets can be divided into two equal doses, therefore a dosage of 31.25 microgram can also be achieved.

Availability outside the Netherlands

Both Acecort and Fludrace are currently only licensed in the Netherlands. (Hospital) Pharmacies with an interest in these products outside the Netherlands can contact us via our contact form.

Please note that these products will be regarded as unlicensed medicines in the destination country. Specific regulations with regards to the import and distribution of these medicines may apply.

* These colours are included in the quality standard ‘Bijnierziekten’ (information in Dutch: www.zorginzicht.nl/kwaliteitsinstrumenten/bijnieraandoeningen).