Примери за използване на Harmonised wording на Английски и техните преводи на Български
{-}
-
Medicine
-
Colloquial
-
Official
-
Ecclesiastic
-
Ecclesiastic
-
Computer
The CHMP adopted the harmonised wording.
A harmonised wording was adopted for Section 5.2.
The CHMP adopted a harmonised wording for Section 4.6.
The CHMP endorsed the MAH proposal for the harmonised wording.
The CHMP adopted a harmonised wording for these sections.
In summary, the CHMP adopted the following harmonised wording.
The CHMP endorsed the harmonised wording under this section.
The CHMP decided to include under this section the harmonised wording.
The MAH proposed a harmonised wording, in line with its Core Data Sheet.
The CHMP agreed to the revised proposal and adopted a harmonised wording for Section 5.1.
In general, the harmonised wording proposed by the MAH was accepted by the CHMP.
In conclusion, the CHMP adopted a harmonised wording for Section 4.9.
Therefore the harmonised wording for this indication is“Treatment of schizophrenia”.
In conclusion, the CHMP adopted a harmonised wording for section 5.1.
A harmonised wording was agreed by the CHMP for inclusion in the harmonised SPCs.
The CHMP adopted a revised harmonised wording for Section 4.7.
In summary, a harmonised wording for inclusion in the harmonised SPCs was agreed and adopted by the CHMP.
The MAH agreed andthe CHMP adopted a harmonised wording for Section 5.3.
The MAH agreed that the harmonised wording for levofloxacin should also be in line with wording for other fluoroquinolones.
The CHMP found the MAH's proposal appropriate andacceptable and endorsed the harmonised wording under this section.
In conclusion, the CHMP adopted a harmonised wording for section 4.2, including the following dose recommendations.
The CHMP agreed with the available information on the interaction studies and adopted a harmonised wording for Section 4.5.
The CHMP adopted a harmonised wording in line with the nationally approved SmPCs, although minor revisions were made.
Since Anthrax is life-threatening,especially when the route of infection is inhalation it was agreed the following harmonised wording for.
The final harmonised wording addresses all the identified discrepancies e.g. differences in frequency of reported adverse events like rhinitis.
The CHMP considered that the justifications provided by the MAH for the proposed wording were acceptable and adopted a harmonised wording for Section 4.8.
It was agreed that the harmonised wording related to section 4.5 is the already approved Seroquel and Seroquel XR MRP SmPC.
However, and since there were fatal post-marketing reports of agranulocytosis the harmonised wording reflects this information.
For Section 4.2, the MAH proposed a harmonised wording, addressing in particular the sections about dosage adjustment, about impaired renal function and on precautions in administration.
Section 4.7- Effects on ability to drive and use machines The majority of markets currently have the proposed harmonised wording, which is in line with the SmPC guideline dated September 2009.