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Laventair (umeclidinium bromide / vilanterol) – Conditions or restrictions regarding supply and use - R03AL03

Updated on site: 08-Oct-2017

Medication nameLaventair
ATC CodeR03AL03
Substanceumeclidinium bromide / vilanterol
ManufacturerGlaxo Group Ltd

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations)

Priory Street

Ware, Hertfordshire SG12 0DJ

United Kingdom

Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations)

Harmire Road

Barnard Castle, County Durham DL12 8DT

United Kingdom

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

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 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 measure:

Description

Due date

Submission of the final clinical study report on a Post-Authorisation Safety (PAS)

By Q3 2024

Observational Cohort Study to Quantify the Incidence and Comparative Safety of

 

Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Laventair

 

compared with tiotropium (study 201038), according to a protocol agreed by the

 

PRAC.

 

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