Pharmaceuticals - Community Register

  

Community 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
5 Riverwalk, Citywest Business Campus, Dublin 24, 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 Community 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/3861/00 (2017)2858 of 24/04/2017