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
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
- Bretaris genuair - aclidinium bromide, micronised
Prescription drugs listed. Substance: "Aclidinium bromide, micronised"
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
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
The MAH shall complete, within the stated timeframe, the below measures:
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.