Angusta® is now approved in 16 EU countries
December 18, 2017
Azanta, a Danish specialty pharmaceutical company dedicated to women’s health, is granted Marketing Authorisation for Angusta® in an additional 11 European countries including France.
Azanta announces that a Marketing Authorisation has been granted for Angusta® in 11 additional EU countries (France, Latvia, Estonia, Poland, Romania, Bulgaria, Czech Republic, Slovakia, Hungary, Slovenia, Croatia) via a Mutual Recognition Procedure (MRP). This additional Marketing Authorisation supplements the existing Angusta® Market Authorisation in the Nordic markets.
Angusta® is Azanta’s proprietary 25 micrograms misoprostol tablet for oral use for induction of labour.
Azanta is excited to have accomplished this important “next wave milestone”, enabling women outside the Nordic countries to also have labour induced by means of an approved oral misoprostol product at dose levels recommended by international guidelines.
“It is important for the women giving birth, the unborn baby, treating physicians, midwives and the
healthcare system in general, that a medicinal product such as Angusta® (misoprostol) is provided at
the recommended strength and approved by health authorities” said Wolfgang Amann, CEO of Azanta
About Angusta® Angusta® is a PGE1 (misoprostol) 25 micrograms oral tablet with a proprietary formulation ensuring high dissolution. The drug has been available on a Named Patient Use Program under special authorisation in Denmark, Norway and Finland since 2013. In Q1 2017 Angusta® was granted Marketing Authorisation in the Nordic countries (Denmark, Sweden, Norway, Finland and Iceland). Approximately 20% of all women giving birth today in the Western world are being induced; a number that is growing.
Azanta is a privately-owned specialty pharma company with a focus on medical treatments in women’s health, oncology and addiction medicine. Azanta seeks to be an international market leader within certain specialty pharma product categories, particularly in niche women’s health and orphan oncology indications, employing innovative repositioning and drug formulation strategies. Azanta currently sells in-licensed and its own medical products in the Nordic countries.
For further information, please visit www.azanta.com.