Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Orfadin   
Auth. number : EU/1/04/303
INN : Nitisinone
Orphan status based on designation EU/3/00/012 added on 24/02/2005
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AX - Various alimentary tract and metabolism products
Chemical substance: A16AX04 - Nitisinone
(See WHO ATC Index)
Indication: Treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine
Marketing Authorisation Holder: Swedish Orphan Biovitrum International AB
SE-112 76, Stockholm, 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
24/02/2005 Centralised - Authorisation EMEA/H/C/555 (2005)457 of 21/02/2005
12/09/2005 Centralised - Variation EMEA/H/C/555/IA/1
20/04/2006 Centralised - Variation EMEA/H/C/555/II/2 (2006)1686 of 18/04/2006
08/06/2006 Centralised - Variation EMEA/H/C/555/IA/5
Updated with Decision(2006)3945 of 28/08/2006
08/06/2006 Centralised - Variation EMEA/H/C/555/IA/4
31/08/2006 Centralised - Annual reassessment EMEA/H/C/555/S/3 (2006)3945 of 28/08/2006
24/11/2006 Centralised - Variation EMEA/H/C/555/IA/6
25/01/2007 Centralised - Variation EMEA/H/C/555/N/7
Updated with Decision(2007)4051 of 23/08/2007
27/08/2007 Centralised - Annual reassessment EMEA/H/C/555/S/8 (2007)4051 of 23/08/2007
19/02/2008 Centralised - Variation EMEA/H/C/555/IA/9
29/04/2008 Centralised - Variation EMEA/H/C/555/IB/11
29/04/2008 Centralised - Variation EMEA/H/C/555/IB/13
29/04/2008 Centralised - Variation EMEA/H/C/555/IB/10
29/04/2008 Centralised - Variation EMEA/H/C/555/IB/12
14/10/2008 Centralised - Variation EMEA/H/C/555/IA/17
14/10/2008 Centralised - Variation EMEA/H/C/555/IA/18
14/10/2008 Centralised - Variation EMEA/H/C/555/IA/15
14/10/2008 Centralised - Variation EMEA/H/C/555/IA/16
27/07/2009 Centralised - Variation EMEA/H/C/555/IA/20
Updated with Decision(2010)345 of 19/01/2010
23/09/2009 Centralised - Annual reassessment EMEA/H/C/555/S/19 (2009)7408 of 21/09/2009
12/01/2010 Centralised - Variation EMEA/H/C/555/IA/22
21/01/2010 Centralised - Renewal EMEA/H/C/555/R/21 (2010)345 of 19/01/2010
29/07/2010 Centralised - Variation EMEA/H/C/555/N/23
Updated with Decision(2011)687 of 01/02/2011
14/09/2010 Centralised - Variation EMEA/H/C/555/IB/24
14/09/2010 Centralised - Variation EMEA/H/C/555/IB/25
27/10/2010 Centralised - Variation EMEA/H/C/555/IA/26/G
Updated with Decision(2011)687 of 01/02/2011
03/02/2011 Centralised - Variation (2011)687 of 01/02/2011
01/03/2011 Centralised - Variation EMEA/H/C/555/IA/27/G
19/07/2013 Centralised - Variation EMEA/H/C/555/IAin/40
Updated with Decision(2014)4509 of 27/06/2014
01/07/2014 Centralised - Variation (2014)4509 of 27/06/2014
25/07/2014 Centralised - Variation EMEA/H/C/555/IB/45