GRADUAL RESUMPTION OF MANUFACTURING AT ITS ANTONY, FRANCE PLANT
Stallergenes Greer is very pleased to announce that the manufacturing and distribution of ORALAIR®, ACTAIR® and ALYOSTAL® Venom are starting after a temporary suspension at its Stallergenes SAS plant in Antony, France.
This follows an inspection carried out by the French Health Agency ANSM, which aimed at ensuring the compliance of the production and distribution chain of these medicines.
This temporary suspension was enacted after observations made by the French Health Agency, regarding the implementation of a new IT system aimed at providing upgraded supply and delivery of Stallergenes Greer’s products. The launch of this new IT system resulted in operational disruptions that have now been satisfactorily addressed.
These products will be available again to our patients as soon as possible and in a sequential manner.
Production and shipping of the ALYOSTAL® Venom will resume gradually. As a result, interim quota related measures are being implemented. The situation of each patient should be considered case by case prioritizing patients currently under treatment.
This is a first step to the relaunch of Stallergenes Greer’s activities. Stallergenes Greer continues to work with the ANSM to promptly resume distribution of its other products, including STALORAL®, PHOSTAL®, and ALUSTAL®. All our teams remain mobilized for a return to normal as soon as possible.
We are aware of the impact of this situation and we wish to reiterate our sincere apologies. We also appreciate your patience and understanding, and we guarantee our commitment on helping patients live their life beyond allergies.
If you are a patient it is important that you refer to your doctor who prescribed your allergy immunotherapy and who is in the best position to provide personalized medical advices .
We are working with those affected to minimise the impact on care and treatment. Please contact your local representative (details can be found here), if you are requesting further information.
Any adverse events should be reported to your national medical authority or to the Stallergenes Greer representative in your country.
Contact information can be accessed at: http://stallergenesgreer.com/about-us/global-network/.
Last update February 8, 2016
