Biopoin
epoetin theta
Table of contents
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Authorisation details
Product details | |
---|---|
Name |
Biopoin
|
Agency product number |
EMEA/H/C/001036
|
Active substance |
epoetin theta
|
International non-proprietary name (INN) or common name |
epoetin theta
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B03XA01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Teva GmbH
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
23/10/2009
|
Contact address |
Product information
23/03/2018 Biopoin - EMEA/H/C/001036 - IAIN/0043
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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Therapeutic indication
Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.
Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.