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Eklira Genuair (aclidinium bromide, micronised) – Conditions or restrictions regarding supply and use - R03BB

Updated on site: 06-Oct-2017

Medication nameEklira Genuair
ATC CodeR03BB
Substanceaclidinium bromide, micronised
ManufacturerAstraZeneca AB

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

Industrias Farmacéuticas Almirall, S.A. Ctra. Nacional II, Km. 593

08740 Sant Andreu de la Barca Barcelona

Spain

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the medicinal product is on the market.

Risk Management Plan (RMP)

The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).

As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).

In addition, an updated RMP should be submitted

When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities

Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached

At the request of the European Medicines Agency.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Obligation to conduct post-authorisation measures

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

Description

Due date

 

 

Post-Authorisation Safety (PAS) Cohort Study of Inhaled Aclidinium Bromide

 

and the Risk of Selected Cardiovascular Endpoints.

PASS will start

Full study protocols should be submitted before the study start for CHMP review

when there are

prior to the product launch.

prescriptions in the defined database

Comments

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