Otsuka Pharmaceutical Netherlands B.V.
10 products tracked · names used in filings: Otsuka Pharmaceutical Netherlands B.V.
Upcoming milestones
No upcoming milestones listed.
Recent milestones
Mon 19 Jan 2026🇪🇺 EU approval (EC decision)
Dawnzera (donidalorsen) approved in the EU
Marketing authorisation to Otsuka Pharmaceutical Netherlands B.V.; Additional monitoring · source
Thu 13 Nov 2025🇪🇺 CHMP positive opinion
Dawnzera (donidalorsen): CHMP positive opinion
Otsuka Pharmaceutical Netherlands B.V.; Additional monitoring · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Asimtufii aripiprazole | Application withdrawn | |
| 🇪🇺 | Abilify MyCite aripiprazole | Application withdrawn | |
| 🇪🇺 | Dawnzera donidalorsen | Authorised | 2026-01-19 |
| 🇪🇺 | Inaqovi cedazuridine;decitabine | Authorised | 2023-09-15 |
| 🇪🇺 | Lupkynis voclosporin | Authorised | 2022-09-15 |
| 🇪🇺 | Rxulti brexpiprazole | Authorised | 2018-07-26 |
| 🇪🇺 | Jinarc tolvaptan | Authorised | 2015-05-27 |
| 🇪🇺 | Abilify Maintena aripiprazole | Authorised | 2013-11-14 |
| 🇪🇺 | Samsca tolvaptan | Authorised | 2009-08-02 |
| 🇪🇺 | Abilify aripiprazole | Authorised | 2004-06-04 |
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.