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23rd January 2024
Fluoroquinolone antibiotics should only be prescribed when ‘no other antibiotics are appropriate for use’, according to a new MHRA drug safety update.
From 22 January 2024, fluoroquinolone antibiotics given systemically – by mouth, injection or inhalation – must only be administered when other recommended antibiotics ‘have failed, will not work due to resistance, or are unsafe to use in an individual patient’, the regulatory agency said.
This is a strengthening of previous regulations from August 2023, which said that fluoroquinolones should not be prescribed for mild-to-moderate or self-limiting infections, or non-bacterial conditions.
The updated drug safety update followed a review into the risk of long-lasting or disabling reactions to fluoroquinolone antibiotics.
The MHRA considered advice from the Commission on Human Medicines and evidence such as Yellow Card reports submitted by patients and healthcare professionals, as well as the experiences of people affected by side effects.
Reports of serious adverse reactions to fluoroquinolone antibiotics have included tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects.
MHRA chief safety officer Dr Alison Cave said: ‘Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.
‘We recognise fully the importance of limiting the use of these medicines. That’s why, from today, fluoroquinolones should only be prescribed when usage of other antibiotics is inappropriate. Fluoroquinolones use should be discontinued at the first signs of a serious adverse reaction.
‘Patients using fluoroquinolone antibiotics should carefully read the advice in the patient information leaflet about possible adverse reactions and seek immediate medical advice if they experience any side effects involving symptoms relating to tendons, muscles, joints, nerves or mental health at any point during treatment.’
The MHRA has reminded healthcare professionals to remain alert to the risk of suicidal thoughts and behaviours with use of fluoroquinolone antibiotics, and to continue to report any suspected adverse reactions to fluoroquinolones via the Yellow Card scheme.
In 2018, the European Medicines Agency called for certain medicines containing this class of antibiotics to be suspended, and for others to be restricted.
Restrictions to the use of fluoroquinolones were introduced in 2019 to minimise the risk of long-lasting or disabling reactions.
17th January 2024
The UK and European medicines regulators are considering new evidence suggesting that children whose fathers took valproate during the three months before conception are at increased risk of neurodevelopmental disorders such as autism.
A new study, commissioned by the European Medicines Agency (EMA), found that around five in 100 children born to fathers treated taking valproate around conception were diagnosed with a disorder, compared with three in 100 children with fathers who took other antiseizure drugs.
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that these results will be ‘rigorously analysed’, but in the meantime urged caution for male patients who want to have children.
‘As a precaution, male patients on valproate who are planning a family in the next year should talk to their healthcare professional about their treatment,’ the MHRA said.
PRAC, the EMA’s safety committee, is also recommending precautionary measures, including that valproate treatment in male patients is started and supervised by a specialist in the management of epilepsy, bipolar disorder or migraine.
’Doctors should inform male patients who are taking valproate about the possible risk and discuss the need to consider effective contraception, for both the patient and their female partner,’ the PRAC said.
It also advised the regular review of valproate treatment in male patients to consider whether it remains the most suitable treatment, particularly when the patient is planning to conceive a child.
’The potential risk of neurodevelopmental disorders and the precautionary measures will be reflected in updates to the product information and educational material for valproate medicines,’ the PRAC concluded, adding that ’a direct healthcare professional communication will be sent in due course to healthcare professionals prescribing, dispensing or administering the medicine’.
Previous recommendations to avoid exposure to valproate medicines in women during pregnancy due to the risk of congenital malformations and neurodevelopmental disorders remain in place.
The PRAC reviewed data from a retrospective observational study carried out by companies that market valproate as an obligation following a previous review of valproate use during pregnancy.
The study used data from multiple registry databases in Denmark, Norway and Sweden and focused on birth outcomes in children born to men who were taking valproate or taking lamotrigine or levetiracetam around the time of conception.
A meta-analysis of data resulted in a pooled adjusted hazard ratio (HR) of 1.50 (95% CI: 1.09-2.07) for neurodevelopmental disorders in children of fathers treated with valproate in the three months prior to conception compared with lamotrigine or levetiracetam.
The adjusted cumulative risk of neurodevelopmental disorders was estimated to be around 5% in the valproate group versus around 3% in the lamotrigine and levetiracetam group. No difference in the risk of congenital malformations was seen between the two groups.
The study did not evaluate the risk of neurodevelopmental disorders in children born to fathers who stopped using valproate more than three months before conception.
The study data on male patients had limitations, including differences between the groups in the conditions for which the medicines were used and in follow-up times.
The PRAC could therefore not establish whether the increased occurrence of these disorders suggested by the study was due to valproate use.
In addition, the study was not large enough to identify which types of neurodevelopmental disorders children could be at increased risk of developing.
Nonetheless, the PRAC considered precautionary measures were warranted to inform patients and healthcare professionals of the potential risks.
In December, the MHRA urged healthcare organisations to prepare for new tightened rules on prescribing valproate which are due to come in later this month.
Under these rules, the epilepsy drug must not be started in new patients – male or female – under the age of 55 unless two specialists have agreed and documented that there are no other effective or tolerated treatments.
In August, when the study on paternal risk was first submitted, the brand leader for valproate informed the MHRA of errors in the study which forced the researchers to conduct a full re-analysis.
After re-submission, the MHRA confirmed it will review the results as part of its ‘ongoing monitoring of the safety of valproate’.
But this will not have ‘implications’ for the new strengthened safety rules coming in this month, according to the MHRA.
Any further guidance resulting from the study’s findings, based on the MHRA’s review and independent advice from the Commission on Human Medicines, will be communicated to healthcare professionals ‘as soon as possible’.
In June last year, NHS England launched a new tool to help with decisions on whether sodium valproate should be prescribed for epilepsy or bipolar disorder by weighing up the benefits and potential harms.
7th December 2023
New regulatory measures tightening the rules around valproate prescribing are set to come into force from January 2024, and the Medicines and Healthcare products Regulatory Agency (MHRA) is urging healthcare organisations to adequately prepare.
From the new year, the first phase of the new measures will curb the use of valproate in new male or female patients under 55 years of age unless two specialists independently find there is no other effective or tolerated treatment, or that there are ‘compelling reasons that the reproductive risks do not apply’.
The measures aim to reduce the significant risk of serious harm to babies if sodium valproate, valproic acid or valproate semisodium are taken during pregnancy, as well as the risk of impaired fertility in males associated with the drug’s use.
These regulatory changes have been recommended by the Commission on Human Medicines to increase scrutiny of valproate prescribing and ensure that valproate is only used when the benefits outweigh the risk.
In addition to limiting new valproate prescribing, the measures include using a revised valproate Annual Risk Acknowledgement Form at the next annual specialist review of all women who could become pregnant and girls who are currently taking valproate.
This review will include the need for a second opinion’s signature if the patient is to continue with valproate.
A similar system will be introduced later in 2024 for male patients currently taking valproate.
The MHRA is urging healthcare organisations to adequately prepare for the changes, including designating a new or existing group to co-ordinate their implementation.
It is also encouraging patients to attend any offered appointments to discuss their treatment plan and to talk to a healthcare professional if they are concerned.
Dr Alison Cave, MHRA chief safety officer, said: ‘To better protect patients from [harm], we are taking robust regulatory action to ensure greater scrutiny of valproate prescribing. Valproate should only be used when no other treatment is effective.’
She added: ‘No one should stop taking valproate without advice from their specialist.’
Dr Henrietta Hughes, the Government’s independent patient safety commissioner for England, said: ‘We must dramatically reduce the number of babies exposed to teratogens which can cause physical and learning disabilities in children. To do this, all organisations must ensure they bring in new measures from January 2024.’
Professor Munir Pirmohamed, chair of the Commission on Human Medicines, added: ‘I am pleased to see the recommendations of the independent Commission on Human Medicines being prepared to be put into practice.
‘Valproate is a highly teratogenic medicine that also carries known risks to male fertility – it is therefore vital valproate is only used when there is no other effective or tolerated treatment option.
‘We have consulted with patients and healthcare professionals with experience of valproate to inform our recommendations and to ensure that they are introduced in a way that does not disrupt ongoing patient care.’
According to the MHRA, it is estimated that one in nine babies exposed to valproate during pregnancy will be born with major birth defects and as many as four in 10 born with a neurological disorder, ranging from poor educational attainment to autism spectrum disorder.
In spring 2018, the MHRA banned the use of valproate for epilepsy during pregnancy without a pregnancy prevention programme.
In May 2023, NHS England launched a valproate decision support tool to help maintain patient safety and curb inappropriate prescribing of valproate during pregnancy.
And in September, new measures recommending the avoidance of all medicines containing topiramate during pregnancy were published by the European Medicines Agency‘s Pharmacovigilance Risk Assessment Committee.
1st December 2023
Carbomer-containing eye gels branded Aacarb, Aacomer and Puroptics have a potential risk of microbial contamination and must be withdrawn from use, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned.
Precautionary safety advice regarding possible infection from the gels has been issued, with healthcare professionals and retailers being advised to withdraw the products. The MHRA is also urging patients to stop using them immediately and return them to their place of purchase.
Users of the gels, which are used to treat dry eye, who have symptoms of an eye infection, such as reduced vision and red or painful eyes, have also been advised to contact a healthcare professional and tell them they have been using an eye gel that has been recalled.
Individuals with cystic fibrosis and patients with certain risk factors are at higher risk of adverse effects from Burkholderia cenocepacia – the bacteria which may have caused the microbial contamination.
As a precautionary measure, the UK Health Security Agency (UKHSA) is additionally recommending that all carbomer-containing lubricating eye gels are avoided where possible in individuals with cystic fibrosis (CF), patients being cared for in critical care settings, those awaiting lung transplantation and anyone who is severely immunocompromised.
The Faculty of Intensive Care Medicine ’wishes to draw members’ attention to the protection briefing note from the UKHSA’.
The possible contamination risk was identified as part of an investigation conducted by the UKHSA after a small number of cases of infection were reported. However, investigations are ongoing and are not conclusive, the MHRA said, adding that the risk to the general public is considered to be low.
A novel cluster of Burkholderia cenocepacia involving 20 cases were identified across the UK. Of these cases, 12 (60%) are male, 18 (90%) are adults and two are paediatric patients (age range six weeks to 82 years, median 57 years). A total of 14 (70%) were critical care inpatients, and two patients have cystic fibrosis.
‘We are working very closely with our colleagues at UKHSA and will issue further advice to protect patients and the public, if needed,’ said Alison Cave, MHRA chief safety officer.
UKHSA is also working with NHS England and CF expert stakeholders to issue communications directly to CF patients, who will be directed to their CF Treatment Centres for further clinical advice.
The MHRA is urging healthcare professionals, or anyone who suspects they may have become unwell after using these eye gels, to report it to the agency’s Yellow Card Scheme.
A version of this article was originally published by our sister publication The Pharmacist.
31st August 2023
A national patient safety alert has been issued in the UK over the risk of death from entrapment or falls relating to medical beds, with a call for all relevant staff to have appropriate training within the next 12 months.
In an alert issued on Wednesday 30 August, the Medicines and Healthcare products Regulatory Agency (MHRA) said it continues to receive reports of death and serious injuries relating to medical beds and trolleys.
Between 1 January 2018 and 31 December 2022, the MHRA received 18 reports of death and 54 reports of serious injuries related to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
The MHRA confirmed to Nursing in Practice that these incidents included medical beds used outside of a hospital setting.
And it said the ‘majority’ of the reported incidents were because of entrapment or falls.
Investigations into incidents that involved falls ‘often found the likely cause to be worn or broken parts, which should have been replaced during regular maintenance and servicing, but which were either not carried out or were carried out improperly’, the MHRA said in its alert.
Meanwhile, those incidents involving entrapment were due to factors including: a lack of risk assessment or risk assessments not being updated following a change in equipment or patient’s condition, a lack of maintenance and servicing, incompatibility issues and children and adults with ‘atypical anatomy using inappropriate equipment’.
As part of its patient safety alert, the MHRA outlined several actions to be taken by all those responsible for the use, purchase, prescription and maintenance of medical beds, including acute and community organisations, care homes, equipment providers, occupational therapists and early intervention teams, to begin and complete by March 2024.
One action called for role-specific training for staff that covered, where appropriate, the ‘risks and operation of these devices, the provision of training to carers/patients, reporting issues, servicing and maintenance and risk assessments’.
And it said that organisations should develop a plan for all staff to be appropriately trained within the next 12 months.
Other actions asked providers to review their medical device management systems, to implement maintenance and servicing schedules and to implement systems to update risk assessments.
Organisations were also urged to update their polices and procedures on procurement, provision, prescribing, servicing and maintenance of such devices in line with updated MHRA guidance.
In addition, it called for patients currently provided with bed rails or bed grab handles to be reviewed ‘to ensure there is a documented up-to-date risk assessment’.
Patients who are children or adults with atypical anatomy should be reviewed ‘as a priority’, it noted.
A version of this story was originally published by our sister publication Nursing in Practice.
17th August 2023
A treatment combining cipaglucosidase alfa (Pombiliti) and miglustat (Opfolda) for adults living with late-onset Pompe disease has been granted marketing authorisation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Cipaglucosidase alfa is a long-term enzyme replacement therapy (ERT) used in combination with the enzyme stabiliser miglustat for adults with late-onset Pompe disease. This rare, inherited lysosomal disorder is caused by deficiency of the enzyme acid alpha-glucosidase (GAA).
The approval comes as the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement of Pombiliti + Opfolda for use within the NHS in England and Wales.
NICE concluded that the cost-effectiveness estimates for Pombiliti + Opfolda showed a positive net health benefit and recommended Pombiliti + Opfolda for adults with late-onset Pompe disease as first line and later lines of therapy.
The MHRA approval and NICE decisions were based on clinical data from the Phase 3 pivotal PROPEL study in which Pombiliti + Opfolda was associated with demonstrable improvements in both musculoskeletal and respiratory measures.
The time to market for Pombiliti + Opfolda was accelerated after it was granted an Innovation Passport under the Innovative Licensing and Access Pathway, a Priority Innovative Medicines designation and a positive scientific opinion under the Early Access to Medicines Scheme. This enabled healthcare professionals to prescribe the treatment prior to marketing authorisation based on clinical factors for patients with a clear unmet need.
In Pompe disease, reduced or absent levels of GAA lead to the accumulation of the substrate glycogen in the lysosomes of muscles and other tissues, leading to skeletal muscle weakness and progressive respiratory involvement.
Professor Mark Roberts, consultant neurologist at the Greater Manchester Neurosciences Unit at Salford Royal NHS Foundation Trust, commented: ‘From the positive uptake of the Early Access to Medicines Scheme, we have already seen the impact that this treatment is having for patients. Having widespread access to this treatment is an exciting development for the Pompe community, giving HCPs and patients a new option that exhibits a novel mode of action.’
Referring to this ‘major step forward’ for late-onset Pompe disease treatment, Bradley Campbell, president and chief executive officer of Amicus Therapeutics, said: ‘We are grateful to the global Pompe community who have helped advance this therapy, especially the patients, families, and physicians who participated in our clinical studies. I am proud of Amicus’ relentless commitment toward ensuring patient access to our innovative therapies, and we are working as quickly as possible to make Pombiliti and Opfolda commercially available.’
Pombiliti + Opfolda will both be added to the Orphan Register held by the MHRA and will benefit from 10 years of market exclusivity.
The European Commission granted approval for Opfolda for adults with late-onset Pompe disease in late June, following its approval of Pombiliti in March 2023.
8th August 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reinforced its emergency anaphylaxis guidance amid a doubling in hospitalisations in England over the last 20 years.
The most recent NHS England figures show 25,721 allergy-related hospital admissions in 2022/23 – an increase of 108% on the 12,361 admissions in 2002/03.
For food-related anaphylaxis and other adverse reactions, the rise was even higher, climbing from 1,971 admissions in 2002/03 to over 5,000 in 2022/23.
The MHRA issued new guidance in June on how to recognise and respond to the signs of anaphylaxis and on the use of adrenaline auto-injectors.
Now, the MHRA is encouraging people to download its advice in light of this new NHS admissions data as the steps, when taken immediately in response to anaphylaxis, can be the difference between life and death, it says.
MHRA chief officer for healthcare quality and access Laura Squire said the figures highlight ‘just how serious the consequences of allergies can be, and the rising numbers of hospitalisations highlights the need to know how to act in an emergency.‘
People at risk of anaphylaxis should always carry two auto-injectors and these should be regularly checked to ensure they have not expired.
In case of an anaphylaxis emergency patients should use their auto-injector without delay and immediately contact 999.
Patients should be made to lay down flat with their legs raised, or lay on their left side if they are pregnant. If there is no improvement after five minutes, a second auto-injector should be used.
Ms Squire added: ‘Knowing how to use an adrenaline auto-injector and what to do afterwards is crucial when responding in an emergency, whether you’re having the reaction yourself or helping someone else.
‘Anaphylaxis is scary for everyone involved and when it strikes, it’s not easy to remember what the right steps are. That’s why we want to encourage everyone to download our guidance now so they can be confident they’re doing the right thing if they’re ever in that situation.’
Aversion of this article was originally published by our sister publication Nursing in Practice.
7th July 2023
Topical ruxolitinib has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of non-segmental vitiligo in adults and adolescents with facial involvement.
The MHRA has granted marketing authorisation for ruxolitinib cream 15mg/g (brand name Opzelura) for treating patients from 12 years of age who have non-segmental vitiligo affecting facial areas.
The approval was based on the findings from two identical phase 3 trials TRuE-V1 and TRuE-V2, which evaluated the efficacy and safety of ruxolitinib cream compared to placebo in over 600 patients with non-segmental vitiligo.
Manufactured by Incyte, Opzelura is now the first and only approved treatment in the UK to offer eligible patients with non-segmental vitiligo support for repigmentation. The MHRA decision follows the European Commission approval in April 2023 and FDA approval in July 2022.
Dr Viktoria Eleftheriadou, consultant dermatologist and lead for vitiligo clinic and research, Walsall Healthcare NHS Trust and The Royal Wolverhampton NHS Trust, said: ‘The MHRA approval is welcome news for dermatologists and people with vitiligo seeking treatment who until now have had limited options. The data supporting this approval demonstrate the potential for ruxolitinib cream to make a difference in the lives of people living with this condition.’
Founder and chief executive officer of the charity Vitiligo Support UK Emma Rush added: ‘While more and more people are proud of their vitiligo, there are still so many people who don’t feel comfortable in their skin. This new treatment option provides a choice for those who wish to treat their condition.’
Voicing the manufacturer’s delight at the approval, Peter Williams, general manager at Incyte UK and Ireland, said: ‘We are now working in partnership with the NHS to ensure that eligible patients seeking to treat their vitiligo are able to access this innovative medicine.’
The combined results of the two randomised, double-blind, vehicle-controlled trials were published as a single paper in the New England Journal of Medicine in October 2022. Both included patients aged 12 years or older who had non-segmental vitiligo with depigmentation covering 10% or less of total body-surface area.
Patients were randomly assigned in a 2:1 ratio to apply 1.5% ruxolitinib cream or vehicle control twice daily for 24 weeks to all vitiligo areas on the face and body, after which all patients could apply 1.5% ruxolitinib cream through to week 52.
The primary end point was an improvement of at least 75% from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), which ranges from 0 to 3, with higher scores reflecting a greater area of facial depigmentation.
A combined total of 674 patients, 330 in TRuE-V1 and 344 in TRuE-V2, were randomised to ruxolitinib. After 24 weeks of therapy, a F-VASI75 response occurred in 29.8% of those taking ruxolitinib in TRuE-V1 compared to 7.4% of those assigned the vehicle control (p < 0.001). Similarly, in TRuE-V2, 0.9% of those receiving ruxolitinib cream achieved a F-VASI75 response (p < 0.001) compared to 7.4% in the vehicle group.
Around one in 100 people in the UK develop vitiligo, with eight in 10 suffering from the non-segmental vitiligo, where both sides of the body are affected by symmetrical white patches. The treatment is approved for twice-daily topical use to the depigmented skin areas up to a maximum of 10% body surface area. Satisfactory re-pigmentation may require treatment with ruxolitinib cream for more than 24 weeks.
22nd June 2023
The MHRA will consider whether further action is needed after a coroner warned doctors were unaware of a rare risk of suicide linked to the commonly used antibiotic ciprofloxacin.
A prevention of future deaths report said that a respected and experienced consultant cardiologist, who had recently retired, died by suicide 11 days after being prescribed a course of ciprofloxacin to relieve his symptoms of prostatitis ahead of investigations for prostate cancer.
The inquest into his death heard that Dr Robert Stevenson, who had worked at Huddersfield Royal Infirmary, had no previous history of depression or mental health problems.
On the day he died, he had left the house for his usual walk and his family had no indications that suggested they should be concerned, coroner Martin Fleming said. The 63-year-old messaged his wife to say that he had left a note under his pillow and was later found dead in a nearby wood.
In a report sent to medicines regulators, Mr Fleming said the urologist who had prescribed the antibiotic had referred him to published literature linking ciprofloxacin and quinoline antibiotics with a potential rare link to suicidal behaviour.
While it was unclear if he was suffering from this side effect, it remained possible, he said.
‘I heard evidence to suggest that the prescribing doctor did not reference this side effect at the time of issuing the prescription to Mr Stevenson, since it was not in accord with current advice,’ Mr Fleming wrote.
‘I also heard evidence to suggest that prescribing doctors may not be fully aware of this rare side effect, and that patient’s suffering from depression may be more vulnerable to it.’
In the report sent to the Medicines and Healthcare products Regulatory Agency (MHRA) he continued: ‘I am therefore concerned that this potential risk has not been given sufficient emphasis and I would ask you to consider the appropriateness of reviewing the current guidelines as to the dispensation of the drug to patients by clinicians and increasing the awareness of the side effect in order to monitor and mitigate the risks.’
Psychiatric side effects, including suicidal behaviours, have been reported following ciprofloxacin and the patient information leaflet warns of these risks, the MHRA said.
In response to the coroner’s report, Dr Janine Jolly, MHRA deputy director of benefit/risk evaluation, said: ‘We are very sorry to hear of Dr Stevenson’s death and would like to express our sympathies to his family.
‘As with any serious suspected side effects, reports of fatalities are evaluated by us including an assessment of post-mortem details if available. We will be reviewing the coroner’s verdict.
‘We will carefully consider the points raised by the coroner in the Regulation 28 Report to consider whether further regulatory action is required to minimise risks to patients and will provide a response upon completion of our investigation.’
Doctors who experience mental health concerns can reach out for support from Doctors in Distress and NHS Practitioner Health.
This story was originally published by our sister title Pulse.
15th March 2023
Pholcodine is an opioid that is approved for use in adults and children over 6 years of age as a treatment for a dry or non-productive cough, although it is also present in other products as a treatment for cough and cold symptoms.
The MHRA in the UK has said that pholcodine containing cough and cold medicines are being withdrawn from the UK market as a precaution following a review and will no longer be available from pharmacies. This decision was based on the potential for an interaction, giving rise to anaphylaxis, with neuromuscular blocking agents (NMBAs). This possible interaction has already been mentioned in the summary of product characteristics for pholcodine.
The MHRA review published on the 14th March 2023, states that recently completed ALPHO study, showed that use of pholcodine during the 12 months preceding anaesthesia was significantly associated with an increased risk of peri-anaesthetic anaphylaxis to NMBAs (adjusted odds ratio = 4.2, 95% CI 2.5 to 6.9).
While information on the risk from pholcodine use beyond 12 months was not available in the ALPHO study, evidence from a study in Norway, showed that IgE-mediated anaphylaxis to neuromuscular blocking agents, was still present, 3 years after withdrawal of pholcodine.
However, the MHRA does add that while the risk of an anaphylactic reaction to NMBAs in less than one case per 10,000 procedures, it still believes that it is necessary to withdraw pholcodine as a precautionary measure.
The action by the MHRA follows a similar move by the European Medicines Agency in December 2022.
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