🇪🇺 CBT-009 in European Union

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

CBT-009 (CBT-009) regulatory status in European Union.

Marketing authorisation

EMA

Application: EMEA/H/C/006385
Marketing authorisation holder: FGK Representative Service GmbH
Local brand name: Atropine sulfate FGK
Indication: Atropine sulfate FGK 0.1 mg/ml is indicated to slow myopia progression in children aged 6 to 10 years with spherical equivalent refraction (SER) in the range of -0.50 to ‑6.00 diopter (D).
Status: rejected

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Frequently asked questions

Is CBT-009 approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for CBT-009 in European Union?

FGK Representative Service GmbH holds the EU marketing authorisation.