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Enurev Breezhaler (glycopyrronium bromide) – Conditions or restrictions regarding supply and use - R03BB06

Updated on site: 06-Oct-2017

Medication nameEnurev Breezhaler
ATC CodeR03BB06
Substanceglycopyrronium bromide
ManufacturerNovartis Europharm Ltd

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

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.

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 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 signifcant 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 safety study on cardio- and cerebrovascular

Final report 5 years after launch.

outcomes (Multinational database cohort study to assess adverse

 

cardiovascular outcomes in association with inhaled

 

glycopyrronium in Europe).

 

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