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Monday 25 March 2019
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Topic: mhra

January 4, 2019
The medicines watchdog has recalled certain batches of products containing ibesartan made by the manufacturer Accord (formerly Actavis) over contamination fears.

The medicines watchdog has recalled certain batches of products containing ibesartan made by the manufacturer Accord (formerly Actavis) over contamination fears.
 
The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday (3 January) recalled the products as a 'precautionary measure' following possible N‑nitrosodiethylamine (NDEA) contamination.
 
It comes as part of a wider European investgation into sartan products, it said.
 

October 29, 2018
Medicines watchdog seizes over £2m counterfeit medicines in UK drugs bust

More than £2m worth of falsified medicines have been seized in the UK in less than three weeks, the Government’s medicines watchdog has revealed.
 
The Medicines and Healthcare products Regulatory Agency (MHRA) said on Wednesday (24 October) that it intercepted one million doses of counterfeit medicines worth over £2m between 9 and 27 October including diazepam, modafinil and dermal fillers.
 

April 26, 2018
<p>Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP)</p>

The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate to protect public health.

 

Valproate medicines (Epilim, Depakote and generic brands) must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP) the regulator announced this month [April 24]. Valproate is a treatment for epilepsy and bipolar disorder.

 

March 14, 2017
Positive scientific opinion under the Early Access to Medicines Scheme (EAMS) recognises the burden of severe atopic dermatitis and significant unmet patient needs

Sanofi, and its specialty care global business unit, Sanofi Genzyme, announced today that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted dupilumab, an investigational treatment for atopic dermatitis (AD), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). The decision means that eligible adults with severe AD can access dupilumab before the drug is granted marketing authorisation in the UK. 

 

August 26, 2016
AbbVie’s first oncology therapy in the UK and the first treatment for CLL to be made available through the Early Access to Medicines Scheme

AbbVie has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted venetoclax, its investigational treatment for chronic lymphocytic leukaemia (CLL), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). The decision means that patients with certain types of difficult-to-treat CLL can now potentially gain access to venetoclax while the relevant regulatory bodies continue to review the marketing authorisation application. 

 

December 10, 2015
2600 hospital pharmacies targeted with single set of clear information for patients

In the largest ever coordinated communication of its type, the British Generic Manufacturers Association (BGMA) has distributed patient information aimed at removing unnecessary duplication and improving impact when contacting pharmacists, GPs and other healthcare professionals about important safety information.
 

 

September 3, 2015
Novartis will provide LCZ696 (sacubitril valsartan) to the NHS for eligible patients enrolled in EAMS

Novartis announced that its investigational heart failure treatment LCZ696 (sacubitril valsartan) has been given a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) for patients with significant unmet medical need.  This allows LCZ696 (sacubitril valsartan) to be made available to eligible patients before a final European licensing decision is made.
 

 

June 24, 2015
Internis Pharmaceuticals Ltd, launches a new MHRA-licenced and approved vitamin D formulation

Internis Pharmaceuticals Ltd, launches a new Medicines and Healthcare Related Products Agency (MHRA)-licenced and approved vitamin D (colecalciferol) formulation; the first commercially available on prescription for the treatment and prevention of vitamin D deficiency in children under five, pregnant women and breastfeeding mothers. Vitamin D deficiency is a serious and increasing UK public health priority, affecting up to 24% of the UK population. (1)

 

July 24, 2014
Almost 23,000 healthcare professionals undertook the National Institute for Health Research Clinical Research Network’s Good Clinical Practice training during 2013–14, latest figures reveal.

Almost 23,000 healthcare professionals undertook the National Institute for Health Research (NIHR) Clinical Research Network’s Good Clinical Practice (GCP) training during 2013–14, latest figures reveal.
All NHS clinical research should be conducted in accordance with the principles of GCP. These principles ensure studies are conducted as safely as possible, to the highest possible quality and with respect for the people taking part in studies.

June 10, 2014
The Medicines and Healthcare Products Regulatory Agency has issued revised guidance for the prescribing and use of adrenaline auto-injectors.

The Medicines and Healthcare Products Regulatory Agency  has issued revised guidance for the prescribing and use of adrenaline auto-injectors (AAIs).

September 22, 2010
Pharmacists will be able to report adverse drug reactions through the Yellow Card scheme more easily thanks to a new health service partnership

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August 12, 2009
MHRA receive 686 adverse reaction reports

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March 7, 2008
Glaxosmithkline (GSK) has been criticised by health regulators for withholding information over the risk of suicide relating to Seroxat (paroxetine)

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