27. 4. 2022

The replacement of the TiO2 (E171) excipient

Titanium dioxide is a frequently used excipient used as a pigment or protective coating in oral solid or semi-solid dosage forms. However, in 2021 EFSA published its opinion on the safety of TiO2 that currently available evidence along with all uncertainties.
4. 4. 2022

Food effect on bioequivalence

The bioequivalence of the medicinal product was proven only under fed conditions and NOT for fasting conditions. The legal basis of Article 10(3) has been applied for the dossier submission. SPC changes considering the difference in bioavailability were proposed as a risk minimization measure.
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