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CMDh has recently published advice regarding requirement for additional variations to product information regarding concomitant use of benzodiazepines/benzodiazepine like products and opioids. As a MAH, you may be required to submit variations to relevant competent authorities to adopt harmonised proposed texts in SmPC and PIL.
Further to the FDA recommendation in August 2016, to add warnings to the drug labelling of prescription opioids (indicated for pain or cough) and benzodiazepines, CMDh has agreed on a proposed text to be included for benzodiazepines and benzodiazepine like products (i.e. z-drugs), with regards to the warnings for concomitant use with opioids. A corresponding text for opioids is also agreed.
The proposed text is guidance on key messages that should be included, taking into account any necessary adaptation to the current product information of the individual product. If the message is already covered in the product information, in a similar wording, there is no need to submit additional variations.
The proposed text is not seen as applicable for products intended for an emergency setting.
If you think you hold marketing authorisations for products that may be affected by this safety advice and wish to file appropriate variations in all/any of the member states in EU/UK; please contact Cambridge Regulatory Services using the contact us form.