Regulatory source library

Oxyglobin: FDA & EMA.

Original veterinary approvals and subsequent documents. Read the source, the jurisdiction, and the scope of each decision.

United States / Veterinary

FDA approval record

Oxyglobin · haemoglobin glutamer-200 (bovine)

Application
NADA 141-067
Original approval
12 January 1998
Species
Dogs
Original sponsor
Biopure Corporation

The original indication concerns anaemic dogs: increasing systemic oxygen content and improving associated clinical signs for at least 24 hours.

Original approval — Freedom of Information summary ↗PDFSupplemental approval — revised dosage information ↗PDFFDA Animal Drugs database ↗Interactive record
How to read these records

The original and supplemental summaries describe different regulatory decisions. Refer to current official labelling and the regulator’s database for prescribing and status questions. These links are not a claim of current commercial availability.

FDA source note
European Union / Veterinary

EU marketing authorisation

European Commission decision · EMA product record

Registration
EU/2/99/015
Original authorisation
29 November 1999
Original decision
C(1999)3846
2021 amendment
18 October 2021

The 1999 annexes contain the product characteristics, authorisation conditions, labelling and package insert. The 2021 decision amends the original authorisation.

EMA Oxyglobin regulatory record ↗Official record1999 Commission annexes — original authorisation ↗PDF2021 Commission decision — authorisation amendment ↗PDF
How to read these records

The historical documents describe particular authorised presentations and changes. Consult the EMA record for the current product information; regulatory status and commercial supply are separate questions.

EMA source note
Separate product / Separate jurisdiction

Hemopure in South Africa

The supplied reference document also covers Hemopure (HBOC-201). This is a human-use product and a separate regulatory history; it is not the Oxyglobin veterinary authorisation.

Published and company-filed accounts describe South African registration in 2001 for acutely anaemic adult surgical patients, to reduce, delay or avoid allogeneic red-cell transfusion. The links below have different evidentiary roles; none is presented as the original South African regulator’s decision.

Peer-reviewed clinical and regulatory account ↗PubMedBiopure regulatory statement filed with the SEC ↗Company filing · 2008Manufacturer’s product and approval history ↗Company source

Historical approvals apply to the named product, jurisdiction and indication. They do not establish FDA or EMA human-use approval for Hemopure, or approval of a new BHOC product. Source links checked 28 August 2026.