Примери за използване на Committee reviewed на Английски и техните преводи на Български
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Colloquial
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Official
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Medicine
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Ecclesiastic
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Ecclesiastic
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Computer
The Committee reviewed the two main studies presented by the company to support the new indication.
To assess its safety, the Committee reviewed the results from preclinical and clinical studies, postmarketing data, epidemiological studies and data from the published literature.
The Committee reviewed all available data and information provided by the MAHs, as well as information provided by GVK Bio;
The Committee reviewed all the data provided by the MAH in writing and the outcome of the adhoc expert advisory group meeting;
The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
The Committee reviewed the data submitted by the applicant in support of this particular medicinal product Diclofenac(Altergon) 50mg tablets;
The Committee reviewed all the data submitted by the applicant in order to support the role of alfacalcidol in the reduction of the fall rate.
The Committee reviewed the totality of the data submitted in relation to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Alkem Laboratories;
In addition, the Committee reviewed the documentation submitted by the MAH in support of the proposed harmonised Quality documentation(Module 3);
The Committee reviewed the available data submitted in support of the new formulation of Basiron containing the new gelling agent excipient Simulgel 600 PHA;
The Committee reviewed all the data submitted by the applicant in order to support the bioequivalence between Didanosine and associated names and the reference product.
The Committee reviewed the totality of the data submitted by the Marketing Authorisation Holder in support of the proposed harmonisation of the product information;
The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Micro Therapeutic Research Labs Limited;
The Committee reviewed all available data on the efficacy and safety of methysergide containing medicinal products, in particular with regard to the risk of fibrotic reactions.
The Committee reviewed all available data, including the responses submitted by the marketing authorisation holders, published studies and post-marketing data;
The Committee reviewed available post marketing data from spontaneous reports of side effects, individual study reports and epidemiological(population-based) studies.
The Committee reviewed the information supplied by the companies that make valproate-containing medicines to support the use of valproate-containing medicine in bipolar disorders.
In addition, the Committee reviewed the totality of the documentation submitted by the Marketing Authorisation Holder in support of the proposed harmonised Quality documentation(Module 3);
The Committee reviewed all available data submitted by the marketing authorisation holder on the safety of Priligy in particular for the 60 mg film-coated tablets and the reported cases of syncope.
The committee reviewed the data submitted by the MAH on clinical studies, post-marketing data and published literature justifying the proposed harmonisation of the product information.
The Committee reviewed all available data submitted by the applicant to address the potential serious risk to public health, in particular the efficacy in respect of long-term asthma control.
The committee reviewed the data submitted by the MAH, including data from clinical trials, published literature and clinical documentation, justifying the proposed harmonised Product Information.
The Committee reviewed the list of ongoing or planned research studies supported by the marketing authorisation holder to investigate bovine neonatal pancytopenia and the potential relation with Pregsure BVD.
The committee reviewed the data submitted by the MAH, including data from clinical trials, published literature and other clinical documentation, justifying the proposed harmonisation of the product information;
The Committee reviewed the available data on submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the SmPC.
The Committee reviewed all available data submitted by the marketing authorisation holder, in particular to support the efficacy of Priligy 60 mg film-coated tablets versus Priligy 30 mg filmcoated tablets.
The committee reviewed the data submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the Product Information.
The Committee reviewed all available data submitted by the applicant to address the potential serious risk to public health, in particular concerning the contraceptive efficacy of the proposed extended dosing regimen.
The committee reviewed the data submitted by the MAH on the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the product information.