Giuseppe
Emeritus
[Source: Italy Ministry of Health, full page in Italian: (LINK). Translated and edited.]
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Norvartis Vaccines Recall: press conference with Health Minister prof. Balduzzi, 5,45pm
Press Release No. 217 ? October 24 2012
The Italian Minister of Health, professor Renato Balduzzi, will convene a press conference today at 5.45 pm (local time) at Ministry headquarter (Lungotevere Ripa 1) about the interdiction to sell some brands of the seasonal influenza vaccines.
Below the text of the note made by the Italian Agency for Drugs Safety (AIFA) sent to all concerned authorities. The number of the involved vaccines doses is of 487,738.
A.I.F.A. NOTE
Following a recent communication received by the Novartis Vaccines and Diagnostics S.r.l., located in Sovicille (SI), Bellaria, in relation to a protein aggregation issue detected during seasonal influenza vaccines manufacturing process (involved products: FLUAD - AGRIPPAL - INFLUPOZZI ADIUVATO e INFLUPOZZI SUBUNIT?), taken into account quality, toxicology and pharmacovigilance assessments made by Novartis Vaccines and Diagnostics S.r.l. company and taken into account these assessments are not enough to clarify the exact composition of the aggregates and the impact on the quality, stability and thus the safety and effectiveness of the involved vaccines, the Agency
ORDERS
on precautionary basis, and awaiting for further investigations and analysis for a comprehensive evaluation of the situation and of the integrative documentation requested to the company, the interdiction to use of the following influenza vaccines: FLUAD - AGRIPPAL - INFLUPOZZI ADIUVATO e INFLUPOZZI SUBUNIT?, as ruled by the legislative decree no. 219/2006, paragraph 142, comma 1, because the drugs have quality issues potentially hazardous to public health.
Novartis Vaccines and Diagnostics S.r.l. company will have to ensure an immediate communication of the above interdiction order to use and sell the vaccines to all drugs? customers, within 48 hours since the reception of this note.
The Carabinieri Command for the Protection of Health is invited to verify the timely communication of the order and ? if in case of a delay from the company ? to proceed to the above mentioned seasonal influenza vaccines seizure.
-Press Release No. 217 ? October 24 2012
The Italian Minister of Health, professor Renato Balduzzi, will convene a press conference today at 5.45 pm (local time) at Ministry headquarter (Lungotevere Ripa 1) about the interdiction to sell some brands of the seasonal influenza vaccines.
Below the text of the note made by the Italian Agency for Drugs Safety (AIFA) sent to all concerned authorities. The number of the involved vaccines doses is of 487,738.
A.I.F.A. NOTE
Following a recent communication received by the Novartis Vaccines and Diagnostics S.r.l., located in Sovicille (SI), Bellaria, in relation to a protein aggregation issue detected during seasonal influenza vaccines manufacturing process (involved products: FLUAD - AGRIPPAL - INFLUPOZZI ADIUVATO e INFLUPOZZI SUBUNIT?), taken into account quality, toxicology and pharmacovigilance assessments made by Novartis Vaccines and Diagnostics S.r.l. company and taken into account these assessments are not enough to clarify the exact composition of the aggregates and the impact on the quality, stability and thus the safety and effectiveness of the involved vaccines, the Agency
ORDERS
on precautionary basis, and awaiting for further investigations and analysis for a comprehensive evaluation of the situation and of the integrative documentation requested to the company, the interdiction to use of the following influenza vaccines: FLUAD - AGRIPPAL - INFLUPOZZI ADIUVATO e INFLUPOZZI SUBUNIT?, as ruled by the legislative decree no. 219/2006, paragraph 142, comma 1, because the drugs have quality issues potentially hazardous to public health.
Novartis Vaccines and Diagnostics S.r.l. company will have to ensure an immediate communication of the above interdiction order to use and sell the vaccines to all drugs? customers, within 48 hours since the reception of this note.
The Carabinieri Command for the Protection of Health is invited to verify the timely communication of the order and ? if in case of a delay from the company ? to proceed to the above mentioned seasonal influenza vaccines seizure.
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