Zerene (zaleplon)
- Region
- 🇪🇺 EU
- Active substance
- zaleplon
- Company
- Meda AB
- Status
- Withdrawn
- Therapeutic area
- Sleep Initiation and Maintenance Disorders
- EU approval
- Fri 12 Mar 1999
- Application
- EMEA/H/C/000228
- ATC
- N05CF03
- Official record
- www.ema.europa.eu
Indication
Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Sonata Withdrawn · Meda AB
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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.