Medicine recalls
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| Resumption of distribution of Novartis Infuenza Vaccines |
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Today (13 November 2012), Novartis Pharmaceuticals (HK) Ltd. (Novartis), a licensed drug wholesaler, informed the Department of Health that the Italian Medicines Agency (AIFA) has announced that the temporary halt on the use of two Novartis Influenza vaccines, namely Agrippal S1 Vaccine Pre-filled Syring Injection (Agrippal) and Fluad Vaccine Pre-filled Syring Injection (Fluad) has been lifted. Both products are manufactured by Novartis Vaccines and Diagnostic s.r.l. in Italy and have been suspended for sale in Italy and Switzerland on 25.10.2012 due to protein aggregates in the vaccines. After investigation, AIFA reaffirmed the safety and efficacy of the vaccines. Moreover, other regulatory authorities including Health Canada and Swissmedic have also lifted the suspension of distribution of Agrippal and Fluad in Canada and Switzerland respectively.
Situation in Hong Kong
In Hong Kong, Agrippal (HK-50901) and Fluad (HK-50982) are registered pharmaceutical products. According to Novartis, Fluad has never been marketed in Hong Kong and Agrippal has been imported to Hong Kong on 30.10.2012. The Department of Health agreed with the assessment of other regulatory authorities and Agrippal can be released to Hong Kong market.
Ends/ Tuesday, November 13, 2012
Issued at HKT 15:18
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