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Лице кое објавува дискусија: lee anhy
lee anhy
lee anhy
Аргентина
Mar 4, 2020

Emma Goldsmith wrote:


Yes. Not only is this the case in the Spanish version (it is missing "For advanced therapy product only"), but also, under Pharmaceutical Form:

"The score line is not intended for breaking the tablet"
is translated as:
"La ranura debe utilizarse para fraccionar el comprimido". (The negative has been omitted).

The Spanish version is dated Versión 8, 07/2011 Rev. 1, 10/2011

I have just emailed EMA.
 


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New EMA QRD templates : Again







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