Примери за използване на Pharmacovigilance activities на Английски и техните преводи на Български
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national competent authorities may request the nomination of a contact person for phar macovigilance issues at national level reporting to the qualified person responsible for pharmacovigilance activities.
of their consideration to revoke the marketing authorisations for Tetrazepam containing medicines further to the evaluation of data resulting from pharmacovigilance activities.
Pfizer Ltd commits to performing the studies and additional pharmacovigilance activities detailed in version 1 of the Risk Management Plan(RMP)
as well as the introduction of routine pharmacovigilance activities in the form of specific follow-up questionnaires to collect safety
other changes to the product information, additional pharmacovigilance activities and risk minimisation measures to address the risk of hypersensitivity events to all patients including administration in pregnancy.
In addition, routine pharmacovigilance activities will be extended to include a cumulative review
additional pharmacovigilance activities and additional risk minimisation measures agreed.
additional pharmacovigilance activities and additional risk minimisation measures agreed.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in
the processing of variation applications and the conduct of pharmacovigilance activities was reasonably high overall.
As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use(CHMP)
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2(August 2007)
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in
As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use(CHMP)
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in
subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 18