Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lumark   
Auth. number : EU/1/15/1013
Active substance : lutetium, isotope of mass 177
ATC: Pending
Indication: Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Marketing Authorisation Holder: IDB Holland B.V.
Weverstraat 17, 5111 PV Baarle-Nassau, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/06/2015 Centralised - Authorisation EMEA/H/C/2749 (2015)4317 of 19/06/2015
20/07/2016 Corrigendum (2015)4317 of 19/06/2015
24/08/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2749T/02 (2016)5485 of 22/08/2016
11/01/2017 Centralised - Variation EMEA/H/C/002749/IAIN/0004
Updated with Decision(2017)6410 of 18/09/2017
20/09/2017 PSUSA - Modification EMEA/H/C/PSUSA/00010391/201612 (2017)6410 of 18/09/2017