Примери за използване на Harmonised wording на Английски и техните преводи на Български
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provided an overview of the differences between the currently approved wording of Section 4.9 and proposed a harmonised wording in line with its Core Data Sheet.
the MAH initially proposed the following harmonised wording for the tablets and IV solution.
The CHMP agreed to the revised proposal and adopted a harmonised wording for Section 5.1.
The CHMP agreed with the available information on the interaction studies and adopted a harmonised wording for Section 4.5.
acute generalised exanthematous pustulosis(AGEP) was reviewed and proposals for a harmonised wording were made.
In summary, a harmonised wording for inclusion in the harmonised SPCs was agreed and adopted by the CHMP.
considered the proposed harmonised wording acceptable.
In particular, the harmonised wording will emphasise that somatropin must not be used if there is any evidence of tumour activity,
The harmonised wording for the SmPC and found in the majority of the EU MSs i.e.“moderate to severe” is considered appropriate
PSUR in September 2014, the CHMP agreed that a harmonised wording in regard of hepatic effects should be assessed and agreed upon in the upcoming PSUR.
The CHMP supported the proposal from the MAH not to include this warning in the harmonised wording, as the published clinical studies do not indicate a significant increase in total cholesterol
the CHMP adopted harmonised wording of product information
available treatment guidelines, that the harmonised wording should include a once daily injection of 150 IU/kg(1.5 mg/kg)
The CHMP adopted the following harmonised wording.
The CHMP agreed on a harmonised wording for the contra-indications.
The CHMP agreed on a harmonised wording for the indications.
In conclusion, the CHMP adopted a harmonised wording according to the PhVWP recommendations.
therefore adopted the following harmonised wording.
The CHMP also adopted a harmonised wording regarding pregnancy and lactation under this section(see SPC).
The initial proposal from the MAH for the EU harmonised wording on Breastfeeding was“Felodipine is detected in breast milk.