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chmp a
the chmp stated that the draft guideline proposed a more conservative approach to the applied acceptance range mainly due to lack of experience in this filed and the fact that pooling may mask the differences in the evaluated products, as is the case for the current product.
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prin urmare, chmp a
the chmp was of the opinion that gemcitabine has shown activity as single agent in mbc but the lack of phase iii trials in this setting makes it difficult to give a specific recommendation about the precise place of gemcitabine in the treatment of advance breast cancer.
chmp a adoptat următoarea formulare:
regarding the posology in elderly with schizophrenia, the chmp considered that the data in elderly patients is limited but suggests that a lower starting dose with a more conservative dose titration than in younger adults is recommended and adopted the following wording:
care a fost recomandarea chmp în momentul respectiv?
reproduction is authorised provided the source is acknowledged. could not have been approved for the treatment of the symptoms of inflammation and pain associated with osteoarthritis.