LEOBENDORF, Oostenrijk–(BUSINESS WIRE)– Croma-Pharma (Croma), heeft vandaag aangekondigd dat de gedecentraliseerde procedure voor het verkrijgen van markttoelating voor zijn botulinumtoxine in Europa is voltooid. Deze belangrijke stap is de basis om het toch al uitgebreide portfolio van Croma te completeren.

Croma’s indiening van botulinumtoxine in Europa is gebaseerd op de gegevens van 3 voltooide, gerandomiseerde, placebogecontroleerde fase III-onderzoeken waarbij in totaal >1000 proefpersonen in Europa en de VS deelnamen. Nationale fasen voor het verlenen van de marktvergunning in heel Europa volgen nu.

Een gamechanger voor Croma-Pharma en de esthetische industrie

Door zijn eigen botulinumtoxine toe te voegen aan het toch al brede portfolio katapulteert Croma zichzelf naar een nieuw niveau binnen de esthetische industrie.

Croma-Pharma Completed the Decentralized Procedure for Its Botulinum Toxin to Treat Glabellar (frown) Lines

LEOBENDORF, Austria–(BUSINESS WIRE)– 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.

About Croma

Founded in 1976, Croma-Pharma GmbH (Croma) is an Austrian family-owned company that specializes in the industrial production of hyaluronic acid syringes for the fields of medical aesthetics, ophthalmology and orthopaedics. Croma currently runs 12 international sales companies and distributes its products in more than 70 countries. Within its global sales network, Croma focuses with own branded products on minimally invasive aesthetic medicine. Besides a broad range of HA fillers from the own production site, Croma markets PDO lifting threads, a Platelet Rich Plasma (PRP) system and high-quality skincare technologies in its core strategic markets.

About Hugel, Inc.

Established in Korea in 2001, Hugel is a global leader in medical aesthetics providing botulinum toxin formulation under different brand names such as BOTULAX and LETYBO in numerous countries across the world. Dedicated to provide proven, high quality medical aesthetic solutions that satisfy both consumers’ and practitioners’ needs, Hugel is leading the Korean market with its botulinum toxin.

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Contacts

CROMA-PHARMA GmbH

Michael Donhofer

Director Global Marketing & Public Relation

Phone: +43 676 84 68 68 823

Mail: michael.donhofer@croma.at
Web: www.croma.at