Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Natpar   
Auth. number : EU/1/15/1078
Active substance : parathyroid hormone
Orphan market exclusivity for "Treatment of hypoparathyroidism" (based on designation EU/3/13/1210) started on 26/04/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 26/04/2027
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H05 - Calcium homeostasis
Pharmacological subgroup: H05A - Parathyroid hormones
Chemical subgroup: H05AA - Parathyroid hormones
Chemical substance: H05AA03 - parathyroid hormone
(See WHO ATC Index)
Indication: Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
Marketing Authorisation Holder: Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/04/2017 Centralised - Authorisation EMEA/H/C/3861 (2017)2858 of 24/04/2017
14/06/2017 Centralised - Variation EMEA/H/C/3861/IAIN/3/G
Updated with Decision(2018)2506 of 19/04/2018
25/01/2018 Centralised - Variation EMEA/H/C/3861/II/5
Updated with Decision(2018)2506 of 19/04/2018
23/04/2018 Centralised - Annual renewal EMEA/H/C/3861/R/7 (2018)2506 of 19/04/2018
22/08/2018 Centralised - Notification EMEA/H/C/3861/N/11
Updated with Decision(2019)269 of 15/01/2019
24/09/2018 Centralised - Variation EMEA/H/C/3861/IAIN/14
Updated with Decision(2019)269 of 15/01/2019
17/01/2019 PSUSA - Modification EMEA/H/C/PSUSA/10591/201804 (2019)269 of 15/01/2019