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Medicines and Healthcare products Regulatory Agency

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Outcome of MHRA review of neuropsychiatric reactions with montelukast

Outcome of MHRA review of neuropsychiatric reactions with montelukast

Monday, 29 April 2024

Further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsych...

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Men on finasteride asked to stay vigilant for possible psychiatric and sexual side effects

Men on finasteride asked to stay vigilant for possible psychiatric and sexual side effects

Monday, 29 April 2024

The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects...

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Fosdenopterin approved to treat adult patients with molybdenum cofactor deficiency (MoCD) Type A

Fosdenopterin approved to treat adult patients with molybdenum cofactor deficiency (MoCD) Type A

Tuesday, 09 April 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 April 2024) approved the medicine fosdenopterin (Nulibry) to treat the gen...

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Precautionary recall of some sodium chloride solutions for irrigation, eyewash and inhalation, manufactured between April and November 2023

Precautionary recall of some sodium chloride solutions for irrigation, eyewash and inhalation, manufactured between April and November 2023

Friday, 05 April 2024

Batches of some products made by Legency Remedies Pvt Ltd have been found to contain a bacteria called Ralstonia pickettii (R. pickettii). All potenti...

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Combined antibiotic approved to treat adult patients with severe infections of the urinary tract and hospital acquired pneumonia

Combined antibiotic approved to treat adult patients with severe infections of the urinary tract and hospital acquired pneumonia

Thursday, 04 April 2024

The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)...

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MHRA warns of unsafe counterfeit anti choking devices

MHRA warns of unsafe counterfeit anti choking devices

Monday, 25 March 2024

Thousands of counterfeit or unbranded copies of LifeVac anti-choking devices are being sold across the UK. The public is reminded to check their produ...

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Disgraced company director convicted of falsifying medicine quality data  

Disgraced company director convicted of falsifying medicine quality data  

Friday, 15 March 2024

A company director and his pharmaceutical manufacturing company were sentenced in court today after pleading guilty to two charges of falsifying data ...

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Modified MAGEC X system for early onset scoliosis treatment can now be used in the UK

Modified MAGEC X system for early onset scoliosis treatment can now be used in the UK

Tuesday, 12 March 2024

The UK suspension of the MAGEC system (modified MAGEC X system only) has been lifted as of 23 February 2024 ...

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MHRA response to Equity in Medical Devices: Independent Review

MHRA response to Equity in Medical Devices: Independent Review

Monday, 11 March 2024

The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review...

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Quizartinib approved to treat adult patients with a type of blood cancer

Quizartinib approved to treat adult patients with a type of blood cancer

Monday, 11 March 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used along...

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Etrasimod approved to treat patients over the age of 16 with ulcerative colitis

Etrasimod approved to treat patients over the age of 16 with ulcerative colitis

Monday, 11 March 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine etrasimod?(Velsipity) to treat people w...

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Ganaxolone approved as first anti seizure medication to treat patients with rare epileptic seizure disorder

Ganaxolone approved as first anti seizure medication to treat patients with rare epileptic seizure disorder

Thursday, 07 March 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine ganaxolone (Ztalmy) as the first anti-se...

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Rozanolixizumab approved to treat adult patients with the autoimmune disease generalised myasthenia gravis

Rozanolixizumab approved to treat adult patients with the autoimmune disease generalised myasthenia gravis

Thursday, 07 March 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine rozanolixizumab (Rystiggo) to treat adul...

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Piflufolastat approved as diagnostic tool for adults with prostate cancer

Piflufolastat approved as diagnostic tool for adults with prostate cancer

Wednesday, 06 March 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the medicine piflufolastat (18F) (Pylclari) as a diag...

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Rubidium (Rb82) Generator approved as a diagnostic tool for people with heart disease

Rubidium (Rb82) Generator approved as a diagnostic tool for people with heart disease

Wednesday, 06 March 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the Rubidium (Rb82) Generator (RUBY-FILL) as a diagno...

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MHRA grants first approval via the new International Recognition Procedure in 30 days

MHRA grants first approval via the new International Recognition Procedure in 30 days

Friday, 01 March 2024

Launched in January 2024, IRP aims to further help bring life-saving new medicines to UK patients without delay...

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MHRA publishes new guidance to help applicants and shorten timeframes for assessment of established medicines

MHRA publishes new guidance to help applicants and shorten timeframes for assessment of established medicines

Wednesday, 28 February 2024

Process changes from 1 March 2024 build on measures already implemented by the agency...

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MHRA Chief Executive Dame June Raine to step down later this year

MHRA Chief Executive Dame June Raine to step down later this year

Monday, 26 February 2024

Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following five years in the role...

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Codeine linctus to be reclassified to a prescription only medicine because of risk of abuse and addiction

Codeine linctus to be reclassified to a prescription only medicine because of risk of abuse and addiction

Tuesday, 20 February 2024

People are urged to seek advice from healthcare professionals if they feel they have become dependent on or addicted to codeine linctus....

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Update on MHRA safety review of medicines containing pseudoephedrine

Update on MHRA safety review of medicines containing pseudoephedrine

Tuesday, 20 February 2024

The MHRA has reviewed the latest evidence relating to the very rare risk of PRES and RCVS associated with medicines containing pseudoephedrine...

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Pioneering genetic biobank to start recruiting patients on stroke prevention medicines

Pioneering genetic biobank to start recruiting patients on stroke prevention medicines

Tuesday, 13 February 2024

The Yellow Card Biobank will today start investigating a new group of medicines known as Direct Oral Anticoagulants...

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MHRA approvals for Comirnaty (Pfizer/BioNTech) and Nuvaxovid (Novavax) COVID 19 vaccines

MHRA approvals for Comirnaty (Pfizer/BioNTech) and Nuvaxovid (Novavax) COVID 19 vaccines

Friday, 09 February 2024

Approval of a change to the licence of Comirnaty COVID-19 vaccine will enable thawing and re-labelling of the vaccine outside of the NHS...

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MHRA announces two new UK Approved Bodies to certify medical devices

MHRA announces two new UK Approved Bodies to certify medical devices

Wednesday, 31 January 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certif...

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New valproate safety measures apply from 31 January

New valproate safety measures apply from 31 January

Wednesday, 31 January 2024

No one should stop taking valproate without advice from their healthcare professional...

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Omjjara licensed for anaemic myelofibrosis patients to treat the symptoms of their disease

Omjjara licensed for anaemic myelofibrosis patients to treat the symptoms of their disease

Wednesday, 31 January 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (30 January 2024) approved the medicine momelotinib (Omjjara) to treat the sy...

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Illegal medicines worth more than £30 million seized in the UK in 2023

Illegal medicines worth more than £30 million seized in the UK in 2023

Tuesday, 30 January 2024

The Medicines and Healthcare products Regulatory Agency (MHRA), working with law enforcement partners, seized more than 15.5 million doses of illegall...

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Rezzayo approved to treat adult patients with invasive candidiasis

Rezzayo approved to treat adult patients with invasive candidiasis

Monday, 29 January 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat a funga...

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Four dose Mounjaro “KwikPen” approved by MHRA for diabetes and weight management

Four dose Mounjaro “KwikPen” approved by MHRA for diabetes and weight management

Thursday, 25 January 2024

The new presentation of Mounjaro gives four doses for once-a-week treatment over a month....

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New safety information for omega 3 acid ethyl ester medicines (Omacor/Teromeg 1000 mg capsules)

New safety information for omega 3 acid ethyl ester medicines (Omacor/Teromeg 1000 mg capsules)

Monday, 22 January 2024

Do not stop your hypertriglyceridemia treatment without a discussion with your doctor...

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MHRA introduces new restrictions for fluoroquinolone antibiotics

MHRA introduces new restrictions for fluoroquinolone antibiotics

Monday, 22 January 2024

Following a review of the effectiveness of current measures to reduce the risk of potentially long-term or irreversible side effects associated with f...

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