date:Aug 14, 2013
e consistent with those for other already approved film-coating agents for use in the EU, including PVA and PEG, however, the Panel noted that no specifications for the impurities ethylene glycol, diethylene glycol, 1,4-dioxane and ethylene oxide are presently included. The co-polymer is not absorbed from the gastrointestinal tract. In repeated dose oral toxicity studies in animals (rat, rabbit, and dogs) no adverse effects were shown.
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