Update of the Product Information Leaflet of Combined Hormonal Contraceptives (CHCs) containing ethinylestradiol
If combined hormonal contraceptives are part of your portfolio, pay attention to the new announcement of the CMDh.
The CMDh has agreed a common text to be included in the product information of combined hormonal contraceptives (CHCs) containing ethinylestradiol regarding the interaction concerning concomitant use with medicinal products containing ombitasvir/paritaprevir/ritonavir (Viekirax) and dasabuvir with or without ribavirin, following the inclusion of the same interaction in the product information of ombitasvir/paritaprevir/ritonavir (Viekirax).
The agreed wording will be published on the CMDh website under “Product Information, CMDh recommendations”. Concerned MAHs are requested to implement the agreed wording via the appropriate regulatory procedure.
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