Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Oxyglobin   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Oxyglobin (ОКСИГЛОБИН) (BG)
Auth. number : EU/2/99/015
INN : Haemoglobin glutamer-200 (bovine)
ATC: Anatomical main group: QB - Blood and blood forming organs
Therapeutic subgroup: QB05 - Blood substitutes and perfusion solutions
Pharmacological subgroup: QB05A - Blood and related products
Chemical subgroup: QB05AA - Blood substitutes and plasma protein fractions
Chemical substance: QB05AA10 - Hemoglobin glutamer (bovine)
(See WHO ATCvet Index)
Indication: Provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition, target species: dogs
Marketing Authorisation Holder: OPK Biotech Netherlands BV
Teleportboulevard 140, NL-1043 EJ Amsterdam, Nederland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/12/1999 Centralised - Authorisation EMEA/V/C/45 (1999)3846 of 29/11/1999
13/04/2001 Centralised - Annual reassessment EMEA/V/C/45/S/2 (2001)832 of 10/04/2001
21/05/2001 Centralised - Variation EMEA/V/C/45/I/1 (2001)1227 of 17/05/2001
15/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/V/C/45/II/3
20/12/2001 Centralised - Variation EMEA/V/C/45/II/4 (2001)5521 of 18/12/2001
18/09/2002 Centralised - Annual reassessment EMEA/V/C/45/S/5 (2002)3426 of 13/09/2002
27/02/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/45/II/5
14/05/2003 Centralised - Annual reassessment EMEA/V/C/45/S/9 (2003)1615 of 12/05/2003
09/12/2004 Centralised - Renewal EMEA/V/C/45/R/6 (2004)4896 of 07/12/2004
28/09/2006 Centralised - Variation EMEA/V/C/45/IA/7
Updated with Decision(2007)1892 of 24/04/2007
26/04/2007 Centralised - Variation (2007)1892 of 24/04/2007
08/06/2007 Centralised - Variation EMEA/V/C/45/IA/10
Updated with Decision(2007)4187 of 03/09/2007
05/09/2007 Centralised - Variation EMEA/V/C/45/II/8 (2007)4187 of 03/09/2007
21/02/2008 Centralised - Variation EMEA/V/C/45/IB/11
Updated with Decision(2008)5218 of 15/09/2008
28/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/45/IB/12
17/09/2008 Centralised - Variation (2008)5218 of 15/09/2008
05/10/2009 Centralised - Renewal EMEA/V/C/45/R/13 (2009)7661 of 01/10/2009
02/12/2011 Centralised - Variation EMEA/V/C/45/IA/14
Updated with Decision(2012)4588 of 28/06/2012
04/07/2012 Centralised - Variation (2012)4588 of 28/06/2012
16/10/2012 Centralised - Variation EMEA/V/C/45/II/16/G (2012)7396 of 15/10/2012