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Respreeza (human alpha1-proteinase inhibitor) – Conditions or restrictions regarding supply and use - B02AB02

Updated on site: 09-Oct-2017

Medication nameRespreeza
ATC CodeB02AB02
Substancehuman alpha1-proteinase inhibitor
ManufacturerCSL Behring GmbH

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

CSL Behring LLC

Route 50 North 1201 N. Kinzie

Bradley, IL 60915

United States

Name and address of the manufacturer responsible for batch release

CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg

Germany

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

Post authorisation efficacy study (PAES): A randomized, long-term

Submission of final

PAES has been agreed to study the dose-relationship if the higher API

clinical study report by

levels achieved in the blood might influence the rate of lung density

31 March 2025

decline and whether that would support an increased dose of 120mg/kg

 

the MAH should conduct and submit the results of a randomized, long

 

term, efficacy study conducted according to an agreed protocol.

 

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