[ad_1]
The Federal Office of Safety in Health Care (BASG) has been informed that several packages of Jakavi 15 mg tablets, for which there is an urgent suspicion of falsification, have entered the legal distribution chain by a parallel distribution.
investigation
Have you ever been touched by a reminder?
To date, it is only false packaging. This means that the blister (primary packaging) and the carton (secondary packaging) have not been produced by the original manufacturer and have not been put on the market by the manufacturer. ;origin. The source of the counterfeit is currently unknown, but has already been investigated by the police.
Obsolete tablets
Initial badyzes by the Agency's Drug Control Laboratory (OMCL) revealed that the tablets in question were likely genuine and original tablets. Thus, the active ingredient could already be identified badytically as being present in an appropriate amount.
It is therefore suspected that the expired original tablets were repackaged by fraudsters or criminal organizations and then illegally placed on the European market. Of the average number of double-digit packages circulating in Austria, about half had already been stopped or quarantined before delivery and delivery. However, it can not be ruled out that some packages of these two lots negotiated on a European scale have already been delivered to individual patients.
The active substance of Jakavi, ruxolitinib, is essentially an active substance that can be described as stable. Therefore, to a limited extent, in case of expiry or improper storage, there is no indication of an acute health risk. However, this precautionary principle is incompatible with safe and effective drug therapy, which is why a full recall of the two affected lots (see above) has been launched. More detailed detail settings (full badysis) of the offending lots regarding the identity and content of the tablets are now in detailed and detailed surveys. These badytical procedures are already in full swing.
In Austria, the following batches of the medicine are concerned:
Name: Jakavi 15 mg tablets
Registration number: EU / 1/12/773 / 002,007-009
Lot numbers:
SM018, SAD42
Licensee: Novartis Europharm Limited
Concurrent Alternative Distributors: Haemato Pharm GmbH and Abacus Medicine A / S
Jakavi is indicated for certain cancers of the blood of the bone marrow.
The reminder is a simple precaution. Nevertheless, for reasons of precaution, it is recommended to replace the affected packaging as soon as possible with a new unaffected packaging. The affected medication is a prescription, so in each case a contact with the doctor must be made.
Stay informed with today.at's newsletter
You may also be interested in this:
(Red)
Source link
