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)
- Rolufta - umeclidinium bromide
- Anoro - umeclidinium bromide / vilanterol trifenatate
- Laventair - umeclidinium bromide / vilanterol
Prescription drugs listed. Substance: "Umeclidinium bromide"
Ware, Hertfordshire SG12 0DJ
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
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
- Rolufta - R03BB07
Prescription drugs listed. ATC Code: "R03BB07"
•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
The MAH shall complete, within the stated timeframe, the below measure:
Submission of the final clinical study report on a
By Q3 2024
Observational Cohort Study to Quantify the Incidence and Comparative Safety of
Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Incruse
compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.