- A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
- B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
- C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
- D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
- E. SPECIFIC OBLIGATION TO COMPLETE
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) of the biological active substance(s)
Boehringer Ingelheim RCV GmbH & Co KG
Name and address of the manufacturer(s) responsible for batch release
- Preotact - parathyroid hormone (rdna)
Prescription drugs listed. Substance: "Parathyroid hormone"
Shire Pharmaceuticals Ireland Limited
Citywest Business Campus
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
•Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
•Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
- Preotact - H05AA03
Prescription drugs listed. ATC Code: "H05AA03"
An updated RMP should be submitted:
•At the request of the European Medicines Agency;
•Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
•Obligation to conduct
The MAH shall complete, within the stated timeframe, the below measures:
The MAH shall
efficacy and safety, the MAH should submit the results of a study based on
plan to include
data deriving from a registry of patients with hypoparathyroidism and who
are treated with NATPAR. The MAH should collect data on clinical hard
reports of the
endpoints (bone, soft tissue calcifications and renal function), together with
registry in the
data on hypercalciuria and quality of life.
The final clinical study report should be submitted by:
31 December 2035.
E. SPECIFIC OBLIGATION TO COMPLETE
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
In order to further confirm the efficacy and safety of NATPAR in the treatment of patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone, the MAH should conduct a randomised controlled trial comparing NATPAR to Standard of Care and to alternative dosing according to an agreed protocol.
The clinical study report should be submitted by:
30 June 2023