Putting Salt On A Sebaceous Cyst

Publication Date: May 18, 2011 - OCTAGAMOCTA 50 mg / ml and 100 mg / ml:

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Category: DRUGS FOR HUMAN USE.



Reference: MUH, 7 / 2011

The AEMPS allows the placing on the market and marketing Octagamocta batches of 50 mg / ml and 100 mg / ml to meet the requirements set by the CHMP.

The English Agency for Medicines and Medical Devices (AEMPS) ordered the withdrawal of all batches of Octagamocta (human immunoglobulin) 5% and 10% (Octapharma SA) dated September 24, 20101.2.







The withdrawal was caused by the increase in reports of thromboembolic events detected in Europe during the second and third quarter of 2010.






were evaluated available data on the quality and safety of Octagamocta and are being analyzed thromboembolic causes of these effects by the regulatory authorities in Europe.






The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines, scientific committee consisting of representatives of all European national agencies, has recommended the lifting of the suspension Octagam marketing (5% and 10%) of Octapharma (Octagamocta) and the return of this product in the market European Union, following the implementation of improvements in the production process that would meet the required quality standards and other preventive measures and subsequent surveillance studies (April 14, 2011) 3.


The AEMPS thus allowing the placing on the market and marketing Octagamocta batches (5% and 10%) which satisfies with the requirements set by the CHMP.




References


ª 1.2 Extension of pharmaceutical warning No 26/10 - OCTAGAMOCTA 50 mg / ml solution for infusion (NR: 66 404) and OCTAGAMOCTA 100 mg / ml solution for infusion (NR: 71 501). English Agency of Medicines and Health Products (Competent Authority). Published online at: http://www.aemps.es/actividad/alertas/usoHumano/calidad/2010/calidad_26-10_ampliacion2.htm (Access revised May 16, 2011)


2.Not Information on withdrawal Octagamocta all lots of 50 mg / ml and 100 mg / ml for an increased risk of thromboembolic events. English Agency of Medicines and Health Products (Competent Authority). Published online at: http://www.aemps.es/actividad/alertas/usoHumano/seguridad/2010/NI_2010-13_octagamocta.htm (Access revised May 16, 2011)


3.European Medicines Agency Recommends or lifting of suspension of Octagam. European Medicines Agency. Published online at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/04/news_detail_001242.jsp&murl = menus / news_and_events / news_and_events.jsp & mid = WC0b01ac058004d5c1 (Access revised May 16, 2011)


Date updated: May 18, 2011