Cymbalta (duloxetine)
- Region
- 🇪🇺 EU
- Active substance
- duloxetine
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Anxiety Disorders; Diabetic Neuropathies; Depressive Disorder, Major
- CHMP opinion
- Thu 16 Sep 2004
- EU approval
- Fri 17 Dec 2004
- Application
- EMEA/H/C/000572
- ATC
- N06AX21
- Official record
- www.ema.europa.eu
Indication
Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Cymbalta is indicated in adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Duloxetine Viatris (previously Duloxetine Mylan) Authorised · Viatris Limited
- 🇺🇸 Duloxetine Hydrochloride Approved · Almatica
- 🇪🇺 Duloxetine Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Duloxetine Lilly Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Yentreve Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Nodetrip (previously Xeristar) Withdrawn · Esteve Pharmaceuticals, S.A.
- 🇪🇺 Ariclaim Withdrawn · Eli Lilly Nederland B.V.
- 🇪🇺 Duloxetine Sandoz Application withdrawn · Sandoz GmbH
- 🇪🇺 Duloxetine Boehringer Ingelheim Withdrawn · Boehringer Ingelheim International GmbH
Follow Cymbalta
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.