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Medicinal Products for Rare and Severe Diseases

Medicinal products for rare and severe diseases are better known as "orphan" medicinal products. Rare diseases are defined as life threatening diseases or diseases that may lead to chronic weaknesses, affecting maximally five out of 10 000 people in the EU. Even though this number of affected persons seems to be small, in 27 European countries it might be said that it comprises approximately 253 000 affected persons. Nowadays, there are between 5000 and 8000 different rare diseases affecting between 6 and 8 % of the entire population, in other words between 27 million and 36 million people in the EU. According to some findings, the medical literature publishes approximately five new rare diseases every day.

Symptoms of rare diseases may be exist from the birth, even though more than 50% of rare diseases appear in adulthood. Approximately 80% of rare diseases has a proven genetic origin, whereas others appear as a result of degenerative or proliferative changes.

Under Medicinal Products Act (Official Gazette No. 71/07, 45/09 and 124/11) in the orphan medicinal products group in the Republic of Croatia may be classified the product with a designated orphan status for rare diseases, according to the current European Union legislation:

  • if it is intended for the diagnosis or treatment of conditions or diseases that lead to chronical weaknesses affecting no more than five per ten thousand persons in the EU, or
  • if it is intended for the diagnosis, prevention or treatment of life threatening conditions or diseases that lead to chronic weaknesses or serious or chronic conditions, but due to high research & development costs it is impossible to place them on the market without necessary incentives
  • if no satisfying diagnostic, prevention and treatment method of these conditions exists, or they exist and the medicine has a proven benefit for the persons affected with this condition.

On the 15 November 2010, HALMED published a list of all orphan medicinal products authorised in the Republic of Croatia, having a designated "orphan" status and the Community Marketing Authorisation (Commission's Decision). The list of medicinal products contains proprietary names, active substances, ATC group and pharmacotherapy area.

Last update of the table: 00.00.0000.

Orphan medicinal products
Name Active Substance ATC Code Pharmacotherapy group