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Natpar (parathyroid hormone) – Conditions or restrictions regarding supply and use - H05AA03

Updated on site: 08-Oct-2017

Medication nameNatpar
ATC CodeH05AA03
Substanceparathyroid hormone
ManufacturerShire Pharmaceuticals Ireland Ltd

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

Dr.-Boehringer-Gasse 5-11

A-1121 Vienna

Austria

Name and address of the manufacturer(s) responsible for batch release

Shire Pharmaceuticals Ireland Limited

5 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

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 web-portal.

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.

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 post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description

Due date

Non-interventional PASS: In order to collect long-term data on clinical

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

regular progress

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.

PSUR.

The final clinical study report should be submitted by:

31 December 2035.

 

 

E. SPECIFIC OBLIGATION TO COMPLETE

POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION

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:

Description

Due date

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

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