Moberg Derma Obtains Approval For Seborrhoeic Eczema Product And Receives Iso 13485 Certification
4/13/2010 3:11:51 PM
Moberg Derma AB today announced that CE mark has been granted for its topical product for the management and relief of common scalp conditions associated with scaly and itchy skin, e.g. seborrhoeic eczema and dandruff. The CE mark provides authorization to market and sell the medical device product in the EU/EEA. The company also announced that it received ISO 13485 certification.
”We are now able to offer a new steroid-free treatment alternative in an indication area dominated by older products. The CE mark is a key milestone for the company and we look forward to making the product available to patients in collaboration with partners and distributors. The ISO 13485 certification is an important quality stamp of our operations”, says Moberg Derma's President and CEO, Peter Wolpert.
About the product and seborrhoeic dermatitis
The product is a prescription free topical solution indicated for the management of common scalp conditions such as seborrhoeic eczema and dandruff. Efficacy and safety have been demonstrated in several clinical studies including more than 300 patients. The product reduces itching and scaling and has a softening and moisturizing effect on the scalp.
Approximately 5% of the population suffers from seborrhoeic eczema of the scalp and skin. There is currently no cure for seborrhoeic eczema, which means that treatment focuses on minimizing symptoms, particularly scaling, erythema and itching.
Contact Moberg Derma
Peter Wolpert, President and CEO
Telephone: +46 8 - 522 307 00
Mobile: +46 70 - 735 71 35
About Moberg Derma
Moberg Derma AB, Stockholm, Sweden, develops and commercializes patented medical products for the treatment of skin disorders. The company focuses on innovative products based on proven compounds. Moberg Derma outlicenses product rights to partners and distributors while maintaining certain promotion rights. The company began operations at the Karolinska Institute in 2006. The principal owners are Östersjöstiftelsen (the Baltic Sea Foundation), private investors and management. For further information, please visit: www.mobergderma.se