Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lonquex   
Auth. number : EU/1/13/856
INN : 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"
V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania

  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