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ArcticZymes Technologies — Regulatory Filings 2014
Mar 26, 2014
3538_iss_2014-03-26_3fc75430-edc3-48cc-a686-3440a7c448dc.html
Regulatory Filings
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MHRA has finalized the review of Woulgan® Biogel
MHRA has finalized the review of Woulgan® Biogel
Biotec BetaGlucans AS has today been informed that MHRA, the UK
Medicines and Healthcare Products Regulatory Agency, has finalized the
review of the medicinal part of the Woulgan® Biogel dossier, and that
their Decision Notification Report has been forwarded to Presafe. MHRA
has been consulted as Competent Authority by the Notified Body, Presafe,
to assess and approve the quality and role of SBG in Woulgan® Biogel.
The final issuance of a CE-certificate for Woulgan® Biogel can now be
finalized by the Notified Body. It is expected that Presafe will have
the formal approval ready within soon.
For more information, please contact:
CEO Svein W. F. Lien, tel +47 922 89 323
About Biotec BetaGlucans AS:
Biotec BetaGlucans is a wholly owned subsidiary of Biotec Pharmacon ASA.
Biotec BetaGlucans develops and manufactures novel immunomodulating
products. The newly developed Woulgan® Biogel, for use in wound healing,
contains the company's proprietary substance SBG® (soluble beta-glucan),
which supports the wound healing process. When receiving CE-mark for the
product the company is ready to start an evaluation study in regular
clinical use together with the wound care world leader Smith & Nephew.
More information on www.biotec.no/beta-glucans/