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EMA withdrawal · 2025-11-28

EMA Refused: Atropine sulfate FGK (atropine sulfate) — FGK Representative Service GmbH

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Summary

EMA refused the marketing authorization for atropine sulfate FGK for myopia (decision date 18 September 2025).

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Diseases / indications

Drugs mentioned

  • Atropine sulfate FGK (atropine sulfate)

Snippet

Status: Refused. Therapeutic area: Myopia. MAH: FGK Representative Service GmbH. Decision date: 18/09/2025