Blood-loss anaemia
Oxyglobin success90%
Control success45%
Archival source note. Detailed numerical and clinical summaries below were retained from the supplied repository notes and have not all been independently revalidated. Use the linked official documents for authoritative wording and current labelling. Open the regulatory source library.
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EMA Approval - Oxyglobin (EU/2/99/015)
Field-Trial Treatment Success
The percentages below are treatment-success rates, not the frequency or severity of each cause of anaemia. Success was defined as no need for additional oxygen-carrying support during the 24-hour efficacy window; it was not a survival endpoint.
Efficacy population · treatment success95% vs 32%Oxyglobin 20/21 · Control 9/28 · p≤0.001
Intent-to-treat · treatment success73% vs 29%Oxyglobin 22/30 · Control 10/34 · p≤0.001
Treatment success by cause of anaemia
Haemolytic anaemia
Oxyglobin success100%
Control success9%
Anaemia from ineffective erythropoiesis
Oxyglobin success100%
Control success50%
How to read “100%”: all evaluable Oxyglobin-treated dogs in that cause-of-anaemia stratum met the 24-hour treatment-success endpoint. It does not mean “100% ineffective erythropoiesis” or “100% haemolysis,” and it is not a 100% survival or cure claim.
EMA Oxyglobin EPAR / Scientific Discussion ↗ · FDA FOI field-trial endpoint and denominators ↗
Overview
| Parameter | Detail |
|---|---|
| Registration Number | EU/2/99/015 |
| Approval Date | 29 November 1999 |
| Decision Number | C(1999)3846 |
| Sponsor | Biopure Corporation |
| Product Name | Oxyglobin |
| Active Substance | haemoglobin glutamer-200 (bovine) |
| EMA Product Number | EMEA/V/C/000045 |
| Species | Dogs |
European Veterinary Approval
The European Commission granted the original marketing authorisation on 29 November 1999, under Decision C(1999)3846 and Community registration EU/2/99/015.
Official Records
- EMA Oxyglobin regulatory record
- Original 1999 European Commission Annexes
- 2001 European Commission Annexes - archived repository copy (18 December)
- 2001 European Commission Annexes - verify at official EC source
- 2021 European Commission authorisation amendment (18 October)
2001 Revised Product Information
The European Commission annexes dated 18 December 2001 provide a primary regulatory source for Oxyglobin 130 mg/mL solution for infusion in dogs. They state that Oxyglobin is a haemoglobin-based oxygen-carrying fluid, identify haemoglobin glutamer-200 (bovine) at 130 mg/mL, and document the product-specific pharmacokinetic, compatibility and storage information summarized below. This historical Oxyglobin record supports veterinary HBOC context; it does not establish approval of BHOC or another future formulation.
Open the archived 2001 European Commission Annexes ↗ · Verify at the official European Commission source ↗
Original Annexes
| Annex | Content |
|---|---|
| Annex I | Summary of Product Characteristics (SmPC) |
| Annex II | Conditions of the Marketing Authorisation |
| Annex III | Labelling and Package Insert |
Presentations
| Version | Presentation |
|---|---|
| Original (1999) | Box containing two separately wrapped 125 mL bags |
| Subsequent presentations (see current EMA product information) | Individual 60 mL and 125 mL presentations |
Therapeutic Indication
Oxyglobin provides oxygen-carrying support to dogs and improves clinical signs of anemia for at least 24 hours, independent of the underlying condition.
"Oxyglobin provides oxygen-carrying support to dogs for at least 24 hours." - EMA Assessment Report
Pharmacokinetics
| Parameter | Detail |
|---|---|
| Plasma Half-life | Approximately 30-40 hours |
| Complete Elimination | 5-7 days |
| Transient Hemoglobinuria | <4 hours (<5% tetramer fraction) |
Safety & Contraindications
| Parameter | Detail |
|---|---|
| Volume Expansion | Dual oxygen-carrying and colloid effects |
| Contraindications | Dogs at risk of circulatory overload (advanced cardiac disease, severely impaired cardiac function, renal impairment with oliguria/anuria) |
| Monitoring | Signs of circulatory overload or CVP measurement |
| Pregnancy/Lactation | Safety not determined; use not recommended |
Storage & Stability
| Parameter | Detail |
|---|---|
| Storage Condition | Do not store above 30°C |
| Shelf Life | 3 years (documented in the 18 December 2001 European Commission Annexes) |
| Do Not Freeze | Yes |
Sources
EMA Oxyglobin EPAR, European Commission primary documents for Oxyglobin (EU/2/99/015), and the FDA field-trial record where the endpoint and population denominators are explicit.
Open the Oxyglobin EU regulatory chronology →
Last updated: 16 September 2026