The Main Pharmaceutical Inspectorate has repealed Decision No. 50 / WS / 2018 of September 26.09.2018, 6000 on the suspension of the medicinal product Clexane, 60 IU, 0,6 mg / XNUMX ml, solution for injection in pre-filled syringes, on the market and nationwide use. .
The GIF decision applies to preparations from the 8CF88A series, with the expiry date: 31/05/2021. The company responsible for the product is Sanofi-Aventis France.
The reason for the withholding was the discovery of a chemical contamination of 4-Nonylphenol in the adhesive that is used to fix the needles in the Clexane-filled pre-filled syringes. However, after investigating and assessing the risk to patients’ health, the manufacturer of the medicinal product concerned concluded that the event did not affect the safety, quality and efficacy of the potentially affected lot of Clexane.
Clexane has been re-admitted to the market in accordance with the GIF decision of July 15.07.2019, XNUMX.
Clexane is a pre-filled syringe containing low molecular weight heparin – enoxaparin. It works on two levels: it prevents the spread of existing blood clots – it helps the body to dissolve them and prevents the formation of further blood clots.
Source: GIF