Replies to post #328034 on Amarin Corp Plc (AMRN)

[postes]

You are a mensch.

[HDGabor]

Well it looks like I made a mistake. I have gone through quite a few and the one got approved made the headline.

A mistake? The one?

Really?

EMA’s human medicines committee (CHMP) recommended 15 medicines for approval at its December 2020 meeting. EU Commission decision (approval date):

1. Enhertu: 18 Jan 2021
2. Heplisav B: 18 Feb 2021
3. Inrebic: 08 Feb 2021
4. Lumoxiti: 08 Feb 2021
5. Retsevmo: 11 Feb 2021
6. Rukobia: 04 Feb 2021
7. Sibnayal: n/a*
8. Tukysa: 11 Feb 2021
9. Kixelle: 05 Feb 2021
10. Yuflyma: 11 Feb 2021
11. Ogluo: 11 Feb 2021
12. Lenalidomide Krka: 11/12 Feb 2021
13. Lenalidomide Krka d.d. Novo mesto: 11/12 Feb 2021
14. Lenalidomide Krka d.d.: 11/12 Feb 2021
15. Sunitinib Accord: 11/12 Feb 2021

* This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

Unfortunately, Lumoxiti did not yield any approval results.

No idea what would you like to li ... opps say ...

HAS ADOPTED THIS DECISION:

Article 1

The marketing authorisation provided for in Article 3 of Regulation (EC) No 726/2004 is granted for the orphan medicinal product "Lumoxiti - moxetumomab pasudotox", the characteristics of which are summarised in Annex I to this Decision. "Lumoxiti - moxetumomab pasudotox" shall be registered in the Union Register of Medicinal Products under number EU/1/20/1522.

Article 2

The marketing authorisation concerning the orphan medicinal product referred to in Article 1 shall be subject to compliance with the requirements set out in Annex II. Those requirements
shall be reviewed annually.