Vevizye (ciclosporin)
- Region
- 🇪🇺 EU
- Active substance
- ciclosporin
- Company
- Laboratoires Théa
- Status
- Authorised
- Therapeutic area
- Keratoconjunctivitis Sicca
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Thu 19 Sep 2024
- Application
- EMEA/H/C/006250
- ATC
- S01XA18
- Official record
- www.ema.europa.eu
Indication
Treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ikervis Authorised · Santen Oy
- 🇪🇺 Verkazia Authorised · Santen Oy
- 🇪🇺 Restaysis Application withdrawn · Allergan Pharmaceuticals International Limited
- 🇪🇺 Vekacia Application withdrawn · Novagali Pharma S.A.
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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.