Lamzede (velmanase alfa)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- velmanase alfa
- Company
- Chiesi Farmaceutici S.p.A.
- Status
- Authorised
- Therapeutic area
- alpha-Mannosidosis
- CHMP opinion
- Thu 14 Dec 2017
- EU approval
- Fri 23 Mar 2018
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/003922
- ATC
- A16AB15
- Official record
- www.ema.europa.eu
Indication
Treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.
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.