Ryjunea (atropine sulfate)
- Region
- 🇪🇺 EU
- Active substance
- atropine sulfate
- Company
- Santen Oy
- Status
- Authorised
- Therapeutic area
- Myopia
- CHMP opinion
- Thu 27 Mar 2025
- EU approval
- Mon 02 Jun 2025
- Application
- EMEA/H/C/006324
- ATC
- S01FA01
- Official record
- www.ema.europa.eu
Indication
Ryjunea is indicated for slowing the progression of myopia in paediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D.
Regulatory milestones
No milestones recorded in the last year.
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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.