其 他 安 全 警 示
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| The European Union : European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) started the review of pholcodine-containing medicines |
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The CHMP has begun looking at the potential link between the use of pholcodine-containing medicines and anaphylactic reactions in patients subsequently exposed to neuromuscular blocking agents (NMBA) used in anaesthesia.
This follows the publication of studies suggesting that pholcodine induces immunologic stimulation in exposed individuals, and that in some Member States where pholcodine is no longer marketed, a decrease in reports of NMBA-related anaphylaxis has been observed.
Pholcodine-containing medicines are used to treat cough in children and adults.
The CHMP will review all available data thoroughly, including published data, non-clinical and clinical data, post-marketing reports and pharmacoepidemiological studies, and will assess their impact on the balance of risks and benefits of these medicines.
Situation in Hong Kong : In Hong Kong, there are 39 registered products containing pholcodine. Further review of the situation will be made when new information is available. |
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