Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lonquex   
Auth. number : EU/1/13/856
Active substance : lipegfilgrastim
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AA - Cytokines
Chemical substance: L03AA14 - Lipegfilgrastim
(See WHO ATC Index)
Indication: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)
Marketing Authorisation Holder: UAB "Sicor Biotech"
Molėtų pl. 5, LT-08409 Vilnius, Lietuva
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
29/07/2013 Centralised - Authorisation EMEA/H/C/2556 (2013)4941 of 25/07/2013
15/04/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2556/T/1 (2014)2589 of 10/04/2014
20/06/2014 Centralised - Variation EMEA/H/C/2556/IAin/3
Updated with Decision(2015)3722 of 28/05/2015
20/11/2014 Centralised - Variation EMEA/H/C/2556/II/4
Updated with Decision(2015)3722 of 28/05/2015
10/02/2015 Centralised - Variation EMEA/H/C/2556/IA/10/G
Updated with Decision(2015)3722 of 28/05/2015
20/03/2015 Centralised - Variation EMEA/H/C/2556/IB/12
Updated with Decision(2015)3722 of 28/05/2015
01/06/2015 Centralised - Yearly update (2015)3722 of 28/05/2015
16/06/2015 Centralised - Variation EMEA/H/C/2556/IB/14
Updated with Decision(2016)3530 of 02/06/2016
26/05/2016 Centralised - Variation EMEA/H/C/2556/II/23
06/06/2016 Centralised - Yearly update (2016)3530 of 02/06/2016
08/07/2016 Centralised - Variation EMEA/H/C/002556/IAIN/0028/G