LEOBENDORF, Austria– Croma-Pharma (Croma), today announced that the decentralized procedure for its botulinum toxin to gain market authorization in Europe has been accomplished. This important step is the basis to complete Croma’s already comprehensive portfolio.
Croma’s botulinum toxin submission in Europe is based on the data of 3 completed randomized, placebo-controlled phase III trials that enrolled a total of >1000 subjects in Europe and the US. National phases to grant the market authorization across Europe are following now.
A game changer for Croma-Pharma and the aesthetic industry
By adding its own botulinum toxin to the already broad portfolio Croma catapults itself to a new level within the aesthetic industry.
Offering already a wide selection of HA fillers, PDO threads, PRP and scientific skincare products, the botulinum toxin was the missing piece to compete with world leaders in this sector.
“We are pleased to announce that our toxin has now accomplished the decentralized procedure in Europe and will continue with the market authorization in major European countries in the next months. With this, we will now be able to complete our portfolio to meet all the needs of our customers”, Managing Director Andreas Prinz points out.
Partnership with Hugel
Croma has licensed the product from the Korean toxin producer Hugel Inc. for Europe and established a joint venture company in 2018 with Hugel, Inc., in order to develop and commercialize Croma’s HA filler products together with Hugel’s botulinum toxin product in the US, Canada, Australia and New Zealand.