Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Signifor   
Auth. number : EU/1/12/753
Active substance : pasireotide
Orphan market exclusivity for "Treatment of acromegaly" (based on designation EU/3/09/670) started on 21/11/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 21/11/2024
Orphan market exclusivity for "Treatment of Cushing's disease" (based on designation EU/3/09/671) started on 27/04/2012
   10 years of market exclusivity
   This orphan market exclusivity will expire on 27/04/2022
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H01 - Pituitary and hypothalamic hormones
Pharmacological subgroup: H01C - Hypothalamic hormones
Chemical subgroup: H01CB - Antigrowth hormone
Chemical substance: H01CB05 - Pasireotide
(See WHO ATC Index)
Indication: Signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
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
27/04/2012 Centralised - Authorisation EMEA/H/C/2052 (2012)2910 of 24/04/2012
17/09/2012 Centralised - Notification EMEA/H/C/2052/N/2
Updated with Decision(2013)5442 of 12/08/2013
06/03/2013 Centralised - Variation EMEA/H/C/2052/IB/6
Updated with Decision(2013)5442 of 12/08/2013
21/03/2013 Centralised - Variation EMEA/H/C/2052/II/5
Updated with Decision(2013)5442 of 12/08/2013
14/08/2013 PSUSA - Modification EMEA/H/C/2052/PSU/8 (2013)5442 of 12/08/2013
23/01/2014 Centralised - Variation EMEA/H/C/2052/II/8
Updated with Decision(2014)8916 of 19/11/2014
07/04/2014 Centralised - Variation EMEA/H/C/2052/IB/13
Updated with Decision(2014)8916 of 19/11/2014
25/04/2014 Centralised - Variation EMEA/H/C/2052/II/12
Updated with Decision(2014)8916 of 19/11/2014
21/11/2014 Centralised - Variation EMEA/H/C/2052/X/10 (2014)8916 of 19/11/2014
02/03/2015 Centralised - Variation EMEA/H/C/2052/IAin/20
Updated with Decision(2016)1523 of 07/03/2016
17/07/2015 Centralised - Notification EMEA/H/C/2052/N/23
Updated with Decision(2016)1523 of 07/03/2016
09/03/2016 Centralised - Yearly update (2016)1523 of 07/03/2016
21/07/2016 Centralised - Variation EMEA/H/C/2052/II/26
Updated with Decision(2016)7597 of 18/11/2016
22/11/2016 Centralised - Renewal EMEA/H/C/2052/R/28 (2016)7597 of 18/11/2016