This site is intended for Healthcare Professionals only

MHRA

suicide-1280x720

Further action taken to minimise suicide risk from finasteride

MHRA recommends further measures to minimise risk of suicidal thoughts associated with finasteride and dutasteride.

12 May 2026

hayfever-1280x720

Fluticasone 0.05pc nasal spray reclassified to be available for children aged 12 and over

MHRA reclassifies fluticasone nasal spray as a P medicine for those aged 12 years and over, available from February 2026.

16 Dec 2025

asthma-1280x720

First twice yearly biological medicine for asthma gets UK approval

The first twice-yearly biological medicine for use as an add-on treatment for asthma has been approved by the MHRA.

16 Dec 2025

tuberculosis-summary

Limit TB drugs to one month’s supply, warns MHRA amid shortages

Prioritise active TB cases to conserve supplies, MHRA tells prescribers

31 Jul 2025

crohns-1280x720

Guselkumab approved for treatment of Crohn’s and ulcerative colitis

Guselkumab already approved for plaque psoriasis and psoriatic arthritis, but studies show it is also effective in moderate to severe Crohn’s disease and UC.

20 May 2025

eczema

Nemolizumab approved for prurigo nodularis and atopic dermatitis

Nemolizumab (Nemluvio, Galderma) has been approved by the MHRA for the treatment of two skins conditions.

18 Feb 2025

covid-research-2024-1280

MHRA approves adapted version of Comirnaty Covid vaccine

The MHRA approved two “presentations of the adapted vaccine” after they met its standards of safety, quality, and effectiveness.

11 Oct 2024

liver-1280x720

Elafibranor approved as first medicine to treat adults with a rare liver disease

Elafibranor (Iqirvo) has been approved by the MHRA to treat adult patients with a rare type of liver disease known as primary biliary cholangitis

08 Oct 2024

approved-1280

First generic raltegravir medicines for HIV patients approved by MHRA

The MHRA has approved generic versions of raltegravir which reduce the amount of HIV in a patient’s blood when used with other medicines.

22 Jul 2024

topiramate-1280x720

New pregnancy prevention measures introduced for topiramate

Migraine and antiseizure medication topiramate (Topamax) must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme

24 Jun 2024

pil-1280x720

Montelukast PIL updated to warn of neuropsychiatric reactions

MHRA says patients should be alert to behaviour and mood-related changes associated with the treatment, and seek urgent medical attention if neuropsychiatric reactions occur.

30 Apr 2024

approved-1280

First anti-seizure medication for rare epileptic disorder approved

Ganaxolone (Ztalmy) treats cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder.

14 Mar 2024

gene-1280x720

Genetic biobank recruiting patients on DOACs in pilot study

By collecting genetic samples, the Yellow Card Biobank aims to determine whether a suspected side effect was caused by a specific genetic trait.

13 Feb 2024

safety-alert-summary

New valproate safety materials released by MHRA

Updated regulatory measures are now in place to reduce the known harms from valproate.

09 Feb 2024

ofloxacin-1280x720

New restrictions on prescribing of fluoroquinolones

Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate, the MHRA advises after safety review

23 Jan 2024

valproate-1280x720

New study suggests risk of disorders in children fathered by men taking valproate

The MHRA advises that, as a precaution, male patients on valproate who are planning a family in the next year should talk to their healthcare professional

16 Jan 2024

Change privacy settings