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    Tag Archives: Product information

    9 Feb

    Update of the Product Information Leaflet of Combined Hormonal Contraceptives (CHCs) containing ethinylestradiol

    News by admin

    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.

    If you have any question or would like to receive more information, you can get in contact with us at info@baupharma.com or register in our newsletter.

    8 Feb

    Mandatory update of class risk effect of corticosteroids in Product Information of EU

    News by admin

    After the CMDh meeting last month and following the recommendations of PRAC, the products containing the following active substances will have to perform an update on their PIL:

    • budesonide
    • misoprostol (gynaecological indication – labour induction)
    • moxifloxacin (systemic use)
    • nadifloxacin
    • nefopam
    • nicardipine
    • sulprostone
    • treprostinil

    PRAC considered that “Blurred Vision” and “Central Serous Chorioretinopathy” is a class risk effect of corticosteroids and should also be included in the product information of the fixed combinations of budesonide as well as other corticosteroids, for all routes of administration. The MAHs of affected products should take due note of the outcome and implement this PRAC recommendation via the appropriate regulatory procedures. Further information regarding the above mentioned will be published on the EMA website.

    8 Feb

    Mandatory update of class risk effect of corticosteroids in Product Information of EU

    News by admin

    After the CMDh meeting last month and following the recommendations of PRAC, the products containing the following active substances will have to perform an update on their PIL:

    • budesonide
    • misoprostol (gynaecological indication – labour induction)
    • moxifloxacin (systemic use)
    • nadifloxacin
    • nefopam
    • nicardipine
    • sulprostone
    • treprostinil

    PRAC considered that “Blurred Vision” and “Central Serous Chorioretinopathy” is a class risk effect of corticosteroids and should also be included in the product information of the fixed combinations of budesonide as well as other corticosteroids, for all routes of administration. The MAHs of affected products should take due note of the outcome and implement this PRAC recommendation via the appropriate regulatory procedures. Further information regarding the above mentioned will be published on the EMA website.