The parallel distributor - "HAEMATO PHARM GmbH" - informed its supplied customers in a letter dated October 8, 2018, that for the two batches of "Jakavi 15 mg tablets" with the batch numbers SM018 and SAD42, packages were delivered in parallel trade in Austria, which "Novartis Europharm Limited" as the marketing authorization holder has not released for marketing in this composition or with these packaging materials. The two batches were manufactured for the French market and exclusively supplied to pharmacies there, which is why they should not have been returned to the distribution chain. HAEMATO PHARM GmbH" therefore recalls these batches as a precautionary measure due to the suspicion of a counterfeit.
|Name of the medicinal product||Jakavi 15 mg Tabletten|
|Marketing authorisation number(s)||EU/1/12/773/002,007-009|
|Marketing authorisation holder||Novartis Europharm Limited|
HAEMATO PHARM GmbH
|Batch number(s)||SM018, SAD42|
|Classification of the recall||1|
|BASG reference number||INS-640.001-2652|