Regulatory source library

Oxyglobin: FDA & EMA.

Original veterinary approvals and subsequent documents for Oxyglobin (hemoglobin glutamer-200, bovine). Oxyglobin is a historical veterinary HBOC precedent; BHOC - Biological Hemoglobin Oxygen Carrier - is a developing category framework, not this approval.

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 decisions · EMA product record

Registration
EU/2/99/015
Original authorisation
29 November 1999
2001 product information
18 December 2001
2021 amendment
18 October 2021

The European regulatory chain is kept together below: original authorisation, revised 2001 product information, and the later Commission amendment.

EMA Oxyglobin regulatory record ↗Official recordEuropean Commission primary documents ↓1999 · 2001 · 2021
How to read these records

The historical documents describe particular authorised presentations and changes.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

Open the detailed EMA / EU source note
European Commission primary documents

Oxyglobin EU regulatory chronology.

One regulatory route, with each primary document linked to its official source. The 2001 annexes are especially useful because they document the revised product information, including 3-year shelf life and the no-typing / no-cross-matching statement.

2021

European Commission authorisation amendment

Later Commission decision retained in the same regulatory chain rather than treated as a separate evidence page.

EC primary sourceAmendment18 Oct 2021
Open 2021 Commission decision ↗Official PDF
Active substanceHaemoglobin glutamer-200 (bovine) · 130 mg/mL
Plasma half-life30-40 hours
CompatibilityNo typing or cross-matching required
Storage / shelf life3 years · do not store above 30°C · do not freeze

Evidence route: Veterinary Oxygen Carrier Evidence → Oxyglobin regulatory records → Oxyglobin & Veterinary HBOC publication catalogue. Regulatory documents stay here; the bibliography remains separate.

Historical approvals apply only to Oxyglobin, the named jurisdiction and indication. They do not establish approval of a new BHOC product. Source links and the 2001 European Commission annexes checked 3 September 2026.