Filgrastim ratiopharm
filgrastim
Table of contents
Overview
The marketing authorisation for Filgrastim ratiopharm has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Filgrastim ratiopharm
|
| Agency product number |
EMEA/H/C/000824
|
| Active substance |
filgrastim
|
| International non-proprietary name (INN) or common name |
filgrastim
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L03AA02
|
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Ratiopharm GmbH
|
| Revision |
1
|
| Date of issue of marketing authorisation valid throughout the European Union |
15/09/2008
|
| Contact address | |
Product information
20/04/2011 Filgrastim ratiopharm - EMEA/H/C/000824 - IB/0001/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Therapeutic indication
Filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Filgrastim ratiopharm is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.