Elaprase (idursulfase)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- idursulfase
- Company
- Takeda Pharmaceuticals International AG Ireland Branch
- Status
- Authorised
- Therapeutic area
- Mucopolysaccharidosis II
- EU approval
- Mon 08 Jan 2007
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/000700
- ATC
- A16AB09
- Official record
- www.ema.europa.eu
Indication
Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.
Regulatory milestones
No milestones recorded in the last year.
Follow Elaprase
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.