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.
EMA Approval — Oxyglobin (EU/2/99/015)
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
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) |
Efficacy Data
| Parameter |
Result |
| Field Trial Success Rate |
95% treated vs 32% untreated controls |
| Blood Loss |
90% vs 45% |
| Hemolysis |
100% vs 9% |
| Ineffective Erythropoiesis |
100% vs 50% |
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 Temperature |
2–30°C |
| Shelf Life |
3 years (approved extension, 1 September 2000) |
| Do Not Freeze |
Yes |
Source
EMA Assessment Report — Oxyglobin (EU/2/99/015)
Last updated: 2026.08