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Norgine B.V. completes important regulatory milestone for ANGUSTA® (misoprostol) in Europe for oral induction of labour
August 17, 2021
Norgine B.V. (Norgine) today announced the successful completion of the Repeat Use Procedure (RUP) for ANGUSTA® in a number of European countries including Austria, Belgium, Cyprus, Germany, Greece, Spain, Ireland, Italy, Luxemburg, Malta, Netherlands, Portugal and the UK. The procedure has been concluded by the Danish Regulatory Authority, the Reference Member State for the assessment.
ANGUSTA® was approved in a number of countries in Europe including the Nordics, France and 10 other Central and Eastern European (CEE) countries in 2017. ANGUSTA® is currently the only approved oral treatment for the induction of labour in France, Denmark, Norway, Iceland, Finland and Sweden. 
There are a number of circumstances where the considered risk to foetal or maternal health outweighs the wait for spontaneous labour and in such cases, labour may be induced. ANGUSTA® will offer an oral treatment choice for the induction of labour in addition to vaginally administered options.  
Alastair Benbow, Chief Development and Medical Officer of Norgine, commented: “Norgine is proud to be offering women and healthcare professionals an oral treatment when induction of labour is required. Norgine would like to make ANGUSTA® available more widely in the future.”
Misoprostol, the active substance in ANGUSTA®, is a synthetic analogue of prostaglandin E1 (PGE1), a naturally occurring compound.  Physiologically, misoprostol has been shown to increase mammalian collagenase activity, causing cervical ripening and uterine contractions. 
Norgine incorporated ANGUSTA® into its portfolio following the recent acquisition of Azanta, which has strengthened Norgine’s position as a leading European specialist pharmaceutical company.
Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 22 million patients around the world in 2019 and generated more than €419 million in net product sales, a growth of 6% over 2018.
Norgine has a direct presence in 12 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.
In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.