Search Results for codeine

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Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017) By Nick Paul Taylor - Published 10 January 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: AstraZeneca, Bristol-Myers Squibb, Merck, CDSCO, codeine

Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (3 January 2017) By Nick Paul Taylor - Published 03 January 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, CFDA guidance, generic drug inspections, codeine

TGA Weighs Rescheduling Codeine Following Safety Review By Michael Mezher - Published 01 October 2015

Codeine-containing medicines may soon be available by prescription only in Australia, following a review and public consultation by the Therapeutic Goods Administration (TGA).

Categories: News, Oceania, TGA, Active pharmaceutical ingredients, Over the counter drugs, Prescription drugs, Government affairs

Tags: Poisons Standard, SUSMP, codeine

EU Committee Wants Additional Restrictions on Codeine Use in Children By Michael Mezher - Published 16 March 2015

A European committee is recommending a series of restrictions on the use of medicines containing codeine in children.

Categories: News, Europe, EMA, Active pharmaceutical ingredients, Drugs, Labeling, Postmarket surveillance

Tags: Codeine, Pediatric use, CMDh, PRAC

FDA Finalizes Boxed Warning for Codeine Product Associated with Pediatric Deaths By Alexander Gaffney, RF News Editor - Published 20 February 2013

Categories: FDA

Tags: URM, Metabolite, Painkiller, Codeine, Children, Pediatric, Latest News

Australia: TGA Restricts OTC Cough and Cold Medications By Ansis Helmanis, RegLink - Published 20 August 2012

Categories: Regulatory Update, TGA

Tags: Codeine, OTC, Children, Pediatric, review

Genetic Predisposition to Codeine Overdose Potentially Fatal to Children, Warns FDA By Alexander Gaffney - Published 15 August 2012

Categories: FDA

Tags: URM, Metabolite, Painkiller, Codeine, Children, Pediatric, Latest News