Atropine sulfate FGK (atropine)

Region: 🇪🇺 EU
Active substance: atropine
Company: FGK Representative Service GmbH
Status: Refused
Therapeutic area: Myopia
CHMP opinion: Thu 18 Sep 2025
Application: EMEA/H/C/006385
ATC: S01FA01
Official record: www.ema.europa.eu

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).

Regulatory milestones

Fri 21 Nov 2025🇪🇺 EU refusal

Atropine sulfate FGK (atropine): EU marketing authorisation refused

FGK Representative Service GmbH · source

Same substance in other markets

🇪🇺 Ryjunea Authorised · Santen Oy

Follow Atropine sulfate FGK

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.