Примери за използване на Mahs на Английски и техните преводи на Български
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Medicine
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Ecclesiastic
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Ecclesiastic
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MAHs Manufacturing Authorization Holders.
The need for a Risk Management Plan was discussed with the MAHs.
The MAHs should evaluate the impact of this DHPC after it is sent out.
In order to improve the overall product comparability, the MAHs should have.
MAHs are encouraged to extend the ongoing drug utilisation study(DUS).
Хората също превеждат
The CHMP considered the MAHs proposals for risk minimisation measures.
The CHMP assessed the revised PI proposals submitted by the MAHs.
The MAHs are strongly encouraged to collaborate to perform a joint study.
For lifting the suspension, the PRAC recommended that MAHs should provide evidence.
The CHMP considered the MAHs' proposals for risk minimisation measures.
It was noted that some of the studies were identical butwere submitted by different MAHs.
The MAHs did not recently conduct any clinical trial with arsenic trioxide in dental paste.
The review of the literature andpost-marketing data provided by the MAHs showed that.
The MAHs did not submit the above mentioned scientific data before the adoption of the initial opinion.
It was noted that some parts of the data submitted were identical butwere submitted by different MAHs.
The MAHs are required to submit the final study report to the EMA as they become available.
Only few data have been submitted by the MAHs regarding resistance in food borne bacteria.
The MAHs should appropriately reformulate the product taking into account its misuse potential.
In addition, any proprietary data submitted by MAHs was evaluated in support of the products investigated in those studies.
The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Cumulative annual reporting of hypersensitivity reactions should be undertaken by all MAHs of these products.
The MAHs should harmonise the relevant wording of the Package Leaflet by reflecting the changes proposed in the SPC.
The Committee reviewed all available data andinformation provided by the MAHs, as well as information provided by GVK Bio;
The MAHs should justify the dosage recommendation and consider appropriate PK/PD data in support of the indication.
Stated frequencies are applicable for pegfilgrastim; for lipegfilgrastim andlenograstim the frequency is to be calculated by the MAHs.
Some MAHs have provided results from bioequivalence data using non-EU Reference Medicinal Products.
Polymicrobial gastrointestinal infections were not identified by the MAHs for the animal species and indications listed for their products.
The MAHs should provide within the risk management plan educational material for prescribers and patients.
The Committee took intoaccount all available data, including the responses from the MAHs and the conclusion of the SAG Oncology;
The CMDh highly recommends that MAHs collaborate in order to avoid unnecessary duplication of studies.