Search Results for codeine

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Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (9 May 2017) By Nick Paul Taylor - Published 09 May 2017

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

Categories: News, Asia, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: NPPA, codeine, pharmaceutical advertising, stent price

FDA Requires Label Changes to Better Protect Children From Pain and Cough Medicines By Zachary Brennan - Published 20 April 2017

The US Food and Drug Administration (FDA) on Thursday announced label changes to two opioids, codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks.

Categories: News, US, FDA, Crisis management, Government affairs, Labeling

Tags: codeine, tramadol, label changes

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Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (3 January 2017) By Nick Paul Taylor - Published 03 January 2017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