Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Neuraceq   
Auth. number : EU/1/13/906
Active substance : florbetaben (18F)
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09A - Central nervous system
Chemical subgroup: V09AX - Other central nervous system diagnostic radiopharmaceuticals
Chemical substance: V09AX06 - Florbetaben (18F)
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.
Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Neuraceq should be used in conjunction with a clinical evaluation.
A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
Marketing Authorisation Holder: Piramal Imaging Limited
Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom
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
24/02/2014 Centralised - Authorisation EMEA/H/C/2553 (2014)1246 of 20/02/2014
09/04/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2553/T/1 (2014)2343 of 03/04/2014
11/07/2014 Centralised - Variation EMEA/H/C/2553/IB/2/G
Updated with Decision(2015)4695 of 03/07/2015
09/10/2014 Centralised - Variation EMEA/H/C/2553/IB/4/G
Updated with Decision(2015)4695 of 03/07/2015
23/02/2015 Centralised - Variation EMEA/H/C/2553/IB/6/G
Updated with Decision(2015)4695 of 03/07/2015
20/05/2015 Centralised - Variation EMEA/H/C/2553/IA/7
Updated with Decision(2015)4695 of 03/07/2015
07/07/2015 Centralised - Yearly update (2015)4695 of 03/07/2015
03/09/2015 Centralised - Variation EMEA/H/C/2553/IB/9/G
21/12/2015 Centralised - Variation EMEA/H/C/2553/IB/11/G