Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: INOmax   
Auth. number : EU/1/01/194
INN : Nitric oxide
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R07 - Other respiratory system products
Pharmacological subgroup: R07A - Other respiratory system products
Chemical subgroup: R07AX - Other respiratory system products
Chemical substance: R07AX01 - Nitric oxide
(See WHO ATC Index)
Indication: INOmax, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of newborns >= 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.
Marketing Authorisation Holder: Linde Healthcare AB
SE-181 81 Lidingö, Sverige

  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
03/08/2001 Centralised - Authorisation EMEA/H/C/337 (2001)2070 of 01/08/2001
27/02/2002 Centralised - Variation EMEA/H/C/337/I/1
04/04/2002 Centralised - Variation EMEA/H/C/337/N/2 (2002)1392 of 02/04/2002
24/10/2002 Centralised - Variation EMEA/H/C/337/I/3 (2002)4123 of 22/10/2002
06/10/2003 Centralised - Variation EMEA/H/C/337/I/4 (2003)3580 of 02/10/2003
03/12/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/337/T/5 (2003)4599 of 01/12/2003
04/08/2004 Centralised - Variation EMEA/H/C/337/II/6 (2004)3058 of 02/08/2004
20/08/2004 Centralised - Variation EMEA/H/C/337/IA/7
04/05/2006 Centralised - Variation EMEA/H/C/337/IA/9
Updated with Decision(2006)3524 of 28/07/2006
02/08/2006 Centralised - Renewal EMEA/H/C/337/R/8 (2006)3524 of 28/07/2006
13/10/2006 Centralised - Variation EMEA/H/C/337/N/10
Updated with Decision(2009)8572 of 29/10/2009
27/02/2009 Centralised - Variation EMEA/H/C/337/IB/11
12/05/2009 Centralised - Variation EMEA/H/C/337/IA/15
15/05/2009 Centralised - Variation EMEA/H/C/337/IB/13
03/07/2009 Centralised - Variation EMEA/H/C/337/IB/16
29/09/2009 Centralised - Variation EMEA/H/C/337/II/14
03/11/2009 Centralised - Variation EMEA/H/C/337/II/17 (2009)8572 of 29/10/2009
03/06/2010 Centralised - Variation EMEA/H/C/337/IA/20
Updated with Decision(2011)188 of 13/01/2011
15/10/2010 Centralised - Variation EMEA/H/C/337/IA/23
Updated with Decision(2011)188 of 13/01/2011
18/01/2011 Centralised - Variation (2011)188 of 13/01/2011
25/01/2011 Centralised - Variation EMEA/H/C/337/II/22 (2011)393 of 21/01/2011
21/03/2011 Centralised - Variation EMEA/H/C/337/II/19 (2011)1891 of 17/03/2011
22/03/2011 Centralised - Variation EMEA/H/C/337/II/19 (2011)1892 of 17/03/2011
22/03/2011 Centralised - Variation EMEA/H/C/337/X/21 (2011)1920 of 18/03/2011
22/03/2011 Centralised - Variation EMEA/H/C/337/X/21 (2011)1921 of 18/03/2011
11/05/2012 Centralised - Variation EMEA/H/C/337/IB/27
Updated with Decision(2012)7897 of 29/10/2012
07/06/2012 Centralised - Variation EMEA/H/C/337/N/29
Updated with Decision(2012)7897 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7897 of 29/10/2012
21/12/2012 Centralised - Variation EMEA/H/C/337/IAin/33
Updated with Decision(2014)310 of 16/01/2014
17/01/2013 Centralised - Variation EMEA/H/C/337/II/30
Updated with Decision(2014)310 of 16/01/2014
16/04/2013 Centralised - Variation EMEA/H/C/337/N/34
Updated with Decision(2014)310 of 16/01/2014
21/11/2013 Centralised - Variation EMEA/H/C/337/II/36
Updated with Decision(2014)310 of 16/01/2014
21/01/2014 Centralised - Variation (2014)310 of 16/01/2014