Cosmo Pharmaceuticals Files Marketing Authorization Application for Methylene Blue MMX 200 mg Tablets with European Medicines Agency
Dublin - February 12, 2019 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced the filing of a Marketing Authorization Application for Methylene Blue MMX 200 mg tablets with the European Medicines Agency (EMA). Methylene Blue MMX is intended as an aid for the visualization and the detection of lesions in subjects undergoing colonoscopy.
The dossier has been granted the Centralized Authorization Procedure in light of the interests of the patients. This means that, if approval will be granted, such approval will be automatically effective in all EU Member States. The review procedure is expected to be concluded within 12 months.
"While we wait for the outcome of the FDA appeal, we continue to pursue the objective of bringing Methylene Blue MMX to other markets. The EMA filing is another positive step toward bringing this innovative drug to patients and endoscopists," said Alessandro Della Chà, CEO Cosmo Pharmaceuticals.
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