Enzepi (pancreas powder)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pancreas powder
- Company
- Allergan Pharmaceuticals International Limited
- Status
- Withdrawn
- Therapeutic area
- Exocrine Pancreatic Insufficiency
- EU approval
- Wed 29 Jun 2016
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002070
- ATC
- A09AA02
- Official record
- www.ema.europa.eu
Indication
Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).Enzepi is indicated in infants, children, adolescents and adults.
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.