- Current languageen
Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/856|
|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:||Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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|