Lacosamide Adroiq (lacosamide)
- Region
- 🇪🇺 EU
- Active substance
- lacosamide
- Company
- Extrovis EU Ltd
- Status
- Authorised
- Therapeutic area
- Epilepsy
- CHMP opinion
- Thu 30 Mar 2023
- EU approval
- Wed 31 May 2023
- Designations
- Generic
- Application
- EMEA/H/C/006047
- ATC
- N03AX18
- Official record
- www.ema.europa.eu
Indication
Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Lacosamide Adroiq is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Lacosamide Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Lacosamide UCB Authorised · UCB Pharma S.A.
- 🇪🇺 Vimpat Authorised · UCB Pharma SA
- 🇪🇺 Lacosamide Pain UCB Pharma Application withdrawn · UCB Pharma S.A.
Follow Lacosamide Adroiq
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.