Примери за използване на Post-authorisation на Английски и техните преводи на Български
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Ecclesiastic
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Computer
Post-authorisation activities.
Inspection(post-authorisation).
Post-Authorisation safety study.
Explanation of post-authorisation categories.
Post-authorisation safety studies.
Obligation to complete post-authorisation measures.
Post-authorisation procedures finalised.
Obligation to conduct post-authorisation measure.
Post-authorisation efficacy study(PAES).
Obligations to conduct post-authorisation measures.
Post-authorisation applications received(2006-2008).
Pharmacovigilance and post-authorisation safety and efficacy of medicines.
Post-authorisation efficacy study(PAES): CRFB002H2301E1.
Producers of plant protection products shall undertake post-authorisation monitoring on the request of the competent authorities.
Post-authorisation efficacy study(PAES): Study 190-203.
The following adverse reactions have been identified in two comparative pivotal Phase 3 studies and one post-authorisation study with Sivextro(Table 1).
Post-authorisation procedures, including pharmacovigilance activities.
Additional safety data include clinical trials, post-authorisation safety studies and post-marketing experience with the mono-components.
Post-authorisation efficacy study(PAES): In order to address the uncertainty regarding.
From April 2017, multinational teams can also evaluate certain post-authorisation applications to extend existing marketing authorisations.
Post-Authorisation efficacy study to provide long-term efficacy and safety data of.
Subject to successful conclusion of pilot activities for both new marketing authorisation applications and post-authorisation activities.
Volume of post-authorisation procedures finalised for human medicines increased by 13%.
The numerical imbalance of breast, bladder and prostate tumours must be considered with caution;it will be further investigated in post-authorisation studies.
Post-authorisation efficacy study(PAES): 60-month follow-up data for study cod 16 HS 13.
Frequency of undesirable effects for TachoSil based on all adverse event data from six clinical trials, two post-authorisation safety studies and spontaneous reporting.
In 2008, the total number of post-authorisation procedures finalised was 2,157, or some 13% higher than in the previous year.
The risk management system must be proportionate to the identified risks andthe potential risks of the medicinal product, and the need for post-authorisation safety data.
Post-authorisation activities relate to variations, extensions of marketing authorisations and transfers of marketing authorisations.
If the same concerns apply to more than one medicinal product, the Agency shall,following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;