Verkazia (ciclosporin)
OrphanAccelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- ciclosporin
- Company
- Santen Oy
- Status
- Authorised
- Therapeutic area
- Conjunctivitis; Keratitis
- CHMP opinion
- Thu 20 Jul 2017
- EU approval
- Fri 06 Jul 2018
- Designations
- Orphan, Accelerated assessment
- Application
- EMEA/H/C/004411
- ATC
- S01XA18
- Official record
- www.ema.europa.eu
Indication
Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ikervis Authorised · Santen Oy
- 🇪🇺 Vevizye Authorised · Laboratoires Théa
- 🇪🇺 Restaysis Application withdrawn · Allergan Pharmaceuticals International Limited
- 🇪🇺 Vekacia Application withdrawn · Novagali Pharma S.A.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.