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News & Press: FDA

Ban on Codeine-containing Cough Syrups

Tuesday, 27 November 2018   (0 Comments)
Posted by: Paul Owusu Donkor
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Ban on Codeine-containing Cough Syrups

 

All registration and market authorisation covering codeine-containing cough syrups, Diphex® with codeine cough syrup, Benylin® with codeine cough syrup and Actifed® dry cough and cold syrup have been revoked. This directive was issued by the Minister for Health, acting through Executive Instrument E. I. 167. The Executive Instrument was gazetted on 26th September, 2018.

The ban on codeine-containing cough syrups follows after the technical report submitted by the Food and Drugs Authority (FDA) to the Ministry of Health.

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Restricted Use of Tramadol and Tramadol-containing Products

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Currently, all other approved dosage forms and strengths of codeine registered by the FDA for other indications in adults and children shall be re-classified as “Controlled Drugs” and dispensed only upon proof of a valid prescription and a record of prescriptions kept. Furthermore, all other approved dosage forms and strengths of codeine registered by the FDA for distribution, dispensing and use shall be re-classified as “Prescription Only Medicines” and maintained as such.