Zentiva k.s.

18 products tracked · names used in filings: Zentiva k.s.

Upcoming milestones

No upcoming milestones listed.

Recent milestones

Thu 12 Nov 2026🇪🇺 EU approval (EC decision)

Ruxolitinib Zentiva (ruxolitinib) approved in the EU

Marketing authorisation to Zentiva k.s.; Generic · source

Thu 17 Sep 2026🇪🇺 CHMP positive opinion

Ruxolitinib Zentiva (ruxolitinib): CHMP positive opinion

Zentiva k.s.; Generic · source

Products

ProductStatusApproved
🇪🇺Ambrisentan Zentiva
ambrisentan
Application withdrawn
🇪🇺Ruxolitinib Zentiva
ruxolitinib
Authorised2026-11-12
🇪🇺Enwylma
denosumab
Authorised2025-06-26
🇪🇺Zadenvi
denosumab
Authorised2025-06-26
🇪🇺Pomalidomide Zentiva
pomalidomide
Authorised2024-07-24
🇪🇺Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
efavirenz;emtricitabine;tenofovir disoproxil
Authorised2017-07-17
🇪🇺Pregabalin Zentiva k.s.
pregabalin
Withdrawn2017-02-27
🇪🇺Ivabradine Zentiva
ivabradine
Authorised2016-11-11
🇪🇺Emtricitabine/Tenofovir disoproxil Zentiva
emtricitabine;tenofovir disoproxil
Authorised2016-11-09
🇪🇺Tenofovir disoproxil Zentiva
tenofovir disoproxil
Authorised2016-09-15
🇪🇺Duloxetine Zentiva
duloxetine
Authorised2015-08-20
🇪🇺Pregabalin Zentiva
pregabalin
Authorised2015-07-17
🇪🇺Aripiprazole Zentiva
aripiprazole
Authorised2015-06-25
🇪🇺Riluzole Zentiva
riluzole
Authorised2012-05-07
🇪🇺Leflunomide Zentiva (previously Leflunomide Winthrop)
leflunomide
Authorised2010-01-08
🇪🇺Clopidogrel Zentiva (previously Clopidogrel Winthrop)
clopidogrel
Authorised2008-07-15
🇪🇺Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel
Withdrawn2007-04-20
🇪🇺Irbesartan Zentiva (previously Irbesartan Winthrop)
irbesartan
Authorised2007-01-19

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.