Duloxetine Zentiva (duloxetine)
Generic
- Region
- 🇪🇺 EU
- Active substance
- duloxetine
- Company
- Zentiva k.s.
- Status
- Authorised
- Therapeutic area
- Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
- CHMP opinion
- Thu 25 Jun 2015
- EU approval
- Thu 20 Aug 2015
- Designations
- Generic
- Application
- EMEA/H/C/003935
- ATC
- N06AX21
- Official record
- www.ema.europa.eu
Indication
Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder. Duloxetine Zentiva 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 Lilly Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Cymbalta 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- 🇪🇺 Nodetrip (previously Xeristar) Withdrawn · Esteve Pharmaceuticals, S.A.
- 🇪🇺 Ariclaim Withdrawn · Eli Lilly Nederland B.V.
- 🇪🇺 Duloxetine Sandoz Application withdrawn · Sandoz GmbH
- 🇪🇺 Duloxetine Boehringer Ingelheim Withdrawn · Boehringer Ingelheim International GmbH
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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.