As Poslovni Dnevnik writes, a very well-known drug is being withdrawn from the market, the Croatian Agency for Medicinal Products and Medical Devices reported on Monday.
Two batches of the drug Champix, produced by the American pharmaceutical giant Pfizer, are being withdrawn. The drug is used to help adults stop smoking, and given the size of the smoking issue here, Croatian patients who are using the drug should give their family doctors a call to be made aware of what they need to do to continue with their therapies.
“In the Republic of Croatia, there are no other batches of these drugs that aren’t affected by this, it’s the same situation with other drugs which contain the active substance varenicline. Therefore, we instruct all users of this medicine to contact their doctor sregarding the continuation of their therapy,” the Agency stated.
As the marketing authorisation holder for Champix, Pfizer, in cooperation with the Agency, is withdrawing from the Croatian market, the following batches of the following pharmaceutical forms of this medicine are set to be no more:
– batch 00023401 of Champix 1 mg film-coated tablets
– batch 00022025 of Champix 0.5 mg and 1 mg film-coated tablets (the pack to start with this therapy).
“The withdrawal is being carried out to the wholesale level. The withdrawal procedure is being carried out due to the increased level of nitrosamine contaminants in the medicinal product compared to the acceptable levels of intake prescribed in the European Union (EU). Based on the available data, there is currently no risk for patients taking this medicine,” the Agency concluded.
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