Category Archives: News

New measures to avoid valproate exposure in pregnancy

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MHRA Statement in response to CMDH announcement of new restrictions on the prescribing of valproate medicines (Epilim, Depakote and other generic brands).

Dr June Raine, Director of MHRA’s Vigilance and Risk Management of Medicines Division said:

We welcome the CMDH endorsement of the strengthened regulatory position on valproate medicines which we have been championing through the Europe-wide review.

Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

These new regulatory measures also include a ban on the use of valproate for migraine or bipolar disorder during pregnancy, and a ban on the use of valproate to treat epilepsy during pregnancy unless there is no other effective treatment available.

Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is important women don’t stop taking valproate without first discussing it with their doctor.

This regulatory position has been developed through close collaboration with professional bodies, health system organisations, and patient and campaign groups.

I would like to particularly thank the families of the Valproate Stakeholder Network who have shared their experiences and expertise with us. Their support will help keep future generations of children safe.

Source – MHRA

GlaxoSmithKline in pole position in Pfizer race

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GlaxoSmithKline is in pole position to win the race for the consumer healthcare business of US pharma giant Pfizer, after it beat a rival bid from Reckitt Benckiser.

Pfizer hopes to secure as much as $20bn for the unit, which sells branded over-the-counter products such as Advil painkillers, Centrum multivitamins and Caltrate calcium supplement.

Both GSK and Reckitt submitted final offers this week ahead of a noon deadline on Wednesday, according to multiple people involved in the process.

If GSK does win the auction it would represent one of the biggest strategic moves so far from Emma Walmsley, who was appointed as chief executive of the British drugmaker last April.

It was unclear if other bidders had emerged in the final weeks of the auction, but attention throughout the sale process had focused on a bidding battle between GSK and Reckitt. Other companies including Johnson & Johnson and Nestlé also followed the process, but ultimately decided not to bid in earlier rounds.

Pfizer has maintained throughout that it was exploring a sell or spin of the business, meaning that if it does not select GSK it could dispose of the unit in another manner. It could also still decide to keep the business.

“An acquisition for the whole Pfizer consumer health business did not fit our acquisition criteria and an acquisition of part of the business was not possible,” Reckitt chief executive Rakesh Kapoor said in a statement late on Wednesday.

 

Source: FT

Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)

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AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure additional batches are also being recalled (EL(18)A/06)

Batch number/expiry

Batch Number Expiry Date Pack Size First Distribution
NG327 31/10/2018 4 x 112 Caps 13/10/2017
NG143 30/11/2018 4 x 112 Caps 19/07/2017
NK719 30/06/2018 4 x 112 Caps 12/10/2017
NJ972 30/06/2018 4 x 112 Caps 01/09/2017
NR730 31/07/2018 4 x 112 Caps 24/11/2017
NK591 30/04/2018 4 x 112 Caps 10/10/2017
NR497 30/04/2018 4 x 112 Caps 18/12/2017

Brief description of the problem

AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure, the other batches listed are also being recalled as they may exceed the limit before the end of their shelf life.
Advice for healthcare professionals

Stop dispensing the batches listed above. Return all remaining stock of these batches to your supplier using the supplier’s approved process.
Wholesalers

Quarantine any remaining stock of these batches and return to the original supplier for credit.
Medical Information enquiries

For medical information enquiries please contact AstraZeneca Medical Information: 0800 783 0033 or medical.informationuk@astrazeneca.com
Stock enquiries

For stock availability queries please contact AstraZeneca Supply Chain: 0800 783 0033 or andy.bailey@astrazeneca.com

EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta

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EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta

Evidence indicates risk of serious inflammatory brain disorders

The European Medicines Agency (EMA) has recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three of the cases were fatal.

A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta. Zinbryta may also be linked to severe immune reactions affecting several other organs.

To protect patients’ health, EMA is recommending the immediate suspension of the medicine‘s marketing authorisation in the EU and a recall of batches from pharmacies and hospitals.

No new patients should start treatment with Zinbryta. Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives. Patients stopping treatment must be followed up for at least 6 months (see more details below).

EMA’s recommendation to suspend Zinbryta and recall the product is being sent to the European Commission for a legally binding decision.

The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine’s marketing authorisation and informed EMA of its intention to stop clinical studies.

Information for patients

If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
Do not take another injection of Zinbryta.
Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting. These could be signs of a reaction to Zinbryta.
Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Information for healthcare professionals

Do not start any new patients on Zinbryta.
Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment. Consider alternative treatments as appropriate.
Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of Zinbryta.
Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting. These reactions can occur for 6 months after treatment has been stopped.
A recall of Zinbryta will take place from pharmacies and hospitals across the EU.
To date EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis. Most cases occurred within 8 months of starting treatment.

A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded that patients stopping treatment should be followed up.

Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.

EMA will complete its in-depth review and make public the final outcome.

More about the medicine

Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis. Following a 2017 review of the medicine’s effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.

To date over 8,000 patients have been treated with Zinbryta worldwide. The majority of EU patients have been treated in Germany.

More about the procedure

The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.

The initial review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.

The PRAC’s recommendation to suspend Zinbryta and recall the product is being sent to the European Commission for a legally binding decision.

UK PM signals intent to remain with EMA

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Prime Minister Theresa May has unveiled the government’s desire for the UK to remain part of the European Medicines Agency following its departure from the European Union.

In a key speech on Brexit she revealed that the government will “explore with the EU the terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries”.

This, she said, would mean “abiding by the rules of those agencies and making an appropriate financial contribution”.

The UK is also committed to “establishing a far-reaching science and innovation pact with the EU”, that would facilitate the exchange of ideas and enable the UK to participate in key programmes alongside EU partners, the PM confirmed.

Healthcare and industry leaders welcomed the announcement.

“Every month, 45 million packs of medicines move from the UK to the EU – and 37 million come the other way. That is why the Prime Minister’s commitment to seek cooperation on medicines regulation would be the best outcome for patients, not just in the UK but across Europe,” said Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry.

“It’s now critical that both sides prioritise patient safety in phase two of the negotiations. Delivering close cooperation on the regulation of medicines is only one part of the challenge. Making sure the supply of medicines is uninterrupted is essential to ensure patients in the UK and EU can get the medicines they need from day one of Brexit.”

Niall Dickson, co-chair of the Brexit Health Alliance, said remaining part of the European Medicines Agency “is the best way to make sure patients have quick access to the drugs and treatments they need”.

“For the Alliance, the key in all this is to put patients first – both the UK Government and European Commission must make public health and patient safety a priority in the negotiations. Nothing less will do.”

The news came as the Association of British Healthcare Industries called for “sensible trading agreements” to be in place the moment the UK leaves the EU to protect patient access to healthcare technologies.

The call comes on the back of research by the group showing that of the £5 billion worth of health technology used in the NHS in 2016, £3.2billion came directly from the EU.

“Complex, international supply chains mean that products can move across a currently frictionless UK/EU border many times in their lifecycle, for sourcing, assembly, packaging and sterilisation. The impact of delays and disruption to this process could pose a significant risk to patients if not correctly managed,” the group warned.

The UK also exports around £2 billion of health technologies to the EU; the same delays and disruptions pose a threat to the health of patients throughout Europe, the ABHI noted.

AZ’ Forxiga to be reviewed for diabetes type I

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AZ’ Forxiga to be reviewed for diabetes type I

The European Medicines Agency has accepted AstraZeneca’s filing for Forxiga as a treatment for diabetes type I.

The submission contains data from the Phase III DEPICT clinical programme, which showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled diabetes type I, induced significant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo.

On the safety side, the drug’s profile was consistent with that established for its use in patients with type II diabetes, except for a higher number of diabetic ketoacidosis (DKA) events, known to occur more frequently in patients with type I disease, AZ said.

Forxiga is a first-in-class SGLT-2 inhibitor which has been on the market in Europe since 2012 for patients with type II diabetes, as both monotherapy and as part of combination therapy to improve blood sugar levels, with the added benefits of blood pressure reductions and weight loss.

With this submission, the drug could potentially become the first selective SGLT-2 inhibitor approved in the region for the treatment of type I diabetes as an oral treatment adjunct to insulin, “helping to address a significant unmet need in this patient population,” the firm noted.

Source: Pharma Times

Natural doesn’t mean safe – herbal medicines found to contain steroids

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Natural doesn’t mean safe – herbal medicines found to contain steroids

People who may have purchased Yiganerjing Cream are urged to discontinue use immediately as it contains an undisclosed steroid and two antifungal ingredients.

The Medicines and Healthcare products Regulatory Agency is warning people who may have purchased a “natural” Chinese herbal medicine, Yiganerjing Cream, as a treatment for skin conditions to stop using it immediately as it has been found to contain an undisclosed steroid and two antifungal ingredients.

MHRA officials have been acting to stop the sale of this cream and have had it withdrawn from many websites and on-line market places but people may have purchased it in the past and still be using it.

Yiganerjing Cream is not a licensed medicine and has been marketed in the UK as a “natural” Chinese herbal medicine for the treatment of a range of skin conditions, most commonly eczema, psoriasis and rosacea.

Our analysis found the presence of the steroid clobetasol propionate. This steroid is the active ingredient in Prescription-Only Medicines used for the treatment of a range skin conditions such as psoriasis and eczema. Creams containing steroids should be used sparingly and as directed by the prescriber. It is contraindicated in children under 1 year of age.

We are also aware of the use, via a herbal clinic, of a product called Penny Orange Cream which has also been found to contain clobetasol propionate. While this product is no longer available, and we are not aware of its widespread use, it did contain an undisclosed steroid and should not be used.

If you are unsure about the safety of a medicine claiming to be “natural” or “herbal” you should check for a Marketing Authorisation (MA) or Product Licence (PL) number or Traditional Herbal Registration (THR) number / the THR logo. This means the product has been assessed by MHRA for safety and has been manufactured correctly. For more information, visit NHS Choices.

Dr Chris Jones, Manager of the Medicines Borderline Section at MHRA said:

The sale of potent steroid creams directly to the public is illegal for good reason. If used without medical supervision these medicines can be dangerous.

Steroids must be prescribed by healthcare professionals who follow strict criteria when prescribing them and monitoring patients using them. They can suppress the skin’s response to infection, can cause long-term thinning of the skin, and if applied long term over a wide area, particularly in babies and children, can cause other medical problems.

Our advice to anyone who is using Yiganerjing Cream, particularly on young children and babies, is to discontinue use immediately. If you have any questions, please contact your healthcare professional.

If you are aware of Yiganerjing cream being sold, please report it to MHRA at Borderline_medicine@mhra.gov.uk.

MHRA update to pharmaceutical companies on exit preparations

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MHRA update to pharmaceutical companies on exit preparations

The European Council formally agreed on 15 December that sufficient progress has been made to move on to the second stage of the negotiations, and adopted guidelines for that second phase.

This followed the publication of a Joint Report on progress during the first phase by the Government and the European Commission on 8 December.

These are important steps forward for both sides and demonstrate the shared interest in managing our exit smoothly, and in moving on with our negotiations.

In the context of ensuring continuity in the availability of goods placed on the market under Union law before withdrawal, the Joint Report makes clear that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.”

The guidelines set out the need for the EU and the UK to complete work on all withdrawal issues and to start drafting the Withdrawal Agreement. The UK looks forward to continuing these discussions.

The EU guidelines also acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EU rules and regulations. The aim is for access to one another’s markets to continue on current terms throughout this period, and for it to be based on the existing structure of EU rules and regulations.

Both parties have recognised the importance of such a period in the interests of providing certainty and continuity to businesses and individuals, and the EU is expected to adopt additional negotiating directives on transitional arrangements in January 2018. The UK expects to be able to rapidly agree the detail with the EU in 2018.

Finally, the guidelines reconfirm the EU’s desire to establish a close future partnership with the UK. As the UK enters the second phase of negotiations, its position on medicines regulation remains clear. The UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety. Its aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.

Preparing for all outcomes
MHRA is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019.

As noted above, the UK’s intention remains to secure an implementation period based on the existing structure of EU rules and regulations as quickly as possible, and to agree a deep and special future partnership.

We will continue to advise businesses on the basis of the UK position and will continue to work with the European Medicines Agency in planning for the UK’s withdrawal from the EU and future relationship.

Current regulatory relationship between UK and European network
It is also important to note that the UK’s current regulatory relationship with the European network remains unchanged. The UK has underlined to Member States and to the EMA on several occasions that at present:

the UK continues to be a full member of the EU: we will fulfil our responsibilities, and, in turn expect to be treated as such.

the UK continues to bid for EMA work and expects its bids to be respected and considered on merit. There are simple, pragmatic solutions to manage the possibility of various outcomes in March 2019: we are, for example, putting forward UK bids in conjunction with other Member States, in the centralised procedure, to ensure business continuity where procedures are likely to run beyond this date.

MHRA have committed to complete all assessments under evaluation at the time that the UK departs from the EU and will make assessment reports available to the network.

the UK continues to carry out its Official Control Authority Batch Release (OCABR) responsibilities as part of the Official Medicines Control Laboratory (OMCL) network for human biologicals.

the UK will continue to put candidates forward for leadership roles where appropriate and expects the committees with responsibility for electing chairs to do so on merit.

UK regulatory requirements after March 2019 in the event of no ongoing relationship with EMA networks
Companies have been asking for detail about UK legislative requirements in different scenarios. We have been working closely with industry associations and other stakeholders and further details on all these issues and more – both our Day One and longer-term proposals – will be published when appropriate.

As stated above, the UK intends to agree a time-limited implementation period with the EU, and both parties have recognised its importance. Should however there be no implementation period, MHRA’s approach would be in line with the following principles:

the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.

we would be pragmatic in establishing UK regulatory requirements. We would give adequate notice and ensure that companies had sufficient time to implement any changed requirements.

where possible, we would be making use of the information we already have to complete administrative tasks for continuity of work and licences.

we would ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.

We will continue to engage with business, patient groups and other stakeholders to help plan ahead with certainty, and will look to publish more technical detail if appropriate.

Source: MHRA

Dispensing defence one of Hunt’s ‘ground-breaking’ plans to end errors

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Health secretary Jeremy Hunt has set out three “ground-breaking” measures to tackle 200 million medication errors across the NHS each year.
Mr Hunt – who set out the initiatives at the Annual World Patient Safety, Science and Technology Summit in London today (February 23) – said they will help to tackle the “appalling levels of harm and death that are totally preventable”.

One of these is the legal defence from criminal sanctions for pharmacists and staff who make an inadvertent dispensing error, which could become law as early as April.

This “will ensure the NHS learns from mistakes and builds a culture of openness and transparency”, the Department of Health and Social Care (DH) said today.

Another is a new system “linking prescribing data in primary care to hospital admissions”, which will help identify “if a prescription was the likely cause of a patient being admitted to hospital”, Mr Hunt said.

This will initially focus on how different medicines may be contributing to hospital admissions linked to gastrointestinal bleeding, and will be rolled out to “a broader range of medicines” following an evaluation in the spring.

Mr Hunt also plans to “accelerate the introduction of electronic prescribing systems” across “more NHS hospitals”, which “could reduce errors by up to 50%”, the DH said in a statement ahead of his speech.

237m medication errors a year
Mr Hunt’s announcement came in response to new research published today by the Universities of Sheffield, York and Manchester, which estimates that “237,396,371 medication errors occur at some point in the medication use process in England” per year. Prescribing errors and dispensing errors account for 21% and 16% respectively, while 54% were “administration errors”, the report’s authors said.

However, of the 237m errors, 72% have little or no potential for harm and “not all these errors would have reached the patient”, the authors stressed.

These medication errors account for 1,708 “definitely avoidable” deaths, according to the research.

The findings, based on 36 studies of “error rates in primary care, care homes and secondary care, and at the various stages of the medication pathway” are “at least 10 years old, so may not reflect current patient populations or practice”, the authors added.

Read a full copy of the report here.

Community pharmacy prevents errors
Responding to the research, National Pharmacy Association (NPA) chief pharmacist Leyla Hannbeck said patient safety is “deeply ingrained in the minds of community pharmacists, who dispense more than a billion prescription items each year”.

“It’s estimated that pharmacists query about 6.6m of those items, helping resolve many incidents that might otherwise have resulted in serious harm,” she added.

Janice Perkins, chair of the Community Pharmacy Patient Safety Group – which consists of representatives of all of the larger pharmacy chains, as well as the NPA – said the organisation is “committed to supporting healthcare leaders” implement Mr Hunt’s initiatives.

“Community pharmacists and their teams play a vital role in preventing medication errors, intervening on prescriptions and minimising risks to patients every day,” she said.

Greater access to patient records
“Discharge medication reviews taking place in community pharmacies, and community pharmacy read/write access to the GP patient record, would be significant enablers” to closer working between general practice and pharmacy teams, Ms Perkins said.

Royal Pharmaceutical Society (RPS) English pharmacy board chair Sandra Gidley also called for pharmacists to receive greater access to “vital information from a patient’s record, to enhance safety”.

“Pharmacists can and have been playing a vital role in reducing medication errors through transfer of patients between care settings,” she added. “We strongly believe that every care home should have a named pharmacist dedicated to improving medicine safety.”

C+D clinical editor Kristoffer Stewart appeared on BBC News this morning calling for pharmacy to have read/write access to patient records.

GPhC: We want to play our part
The General Pharmaceutical Council (GPhC) said it “strongly agrees” that “it is vital to have a learning culture across healthcare”.

“We will continue our work to promote a culture of openness, honesty and learning across pharmacy, and we will be urging everyone who employs pharmacy professionals or works within pharmacy to do the same,” chief executive Duncan Rudkin said.

Numark managing director Jeremy Meader said: “Pharmacy takes great pride in dispensing prescriptions accurately, as evidenced by the significantly low numbers of dispensing errors that occur.”

Mr Meader commended Mr Hunt’s support of the legal defence for dispensing errors, and said Numark “will be seeking further dialogue with Jeremy Hunt to continue to promote the vital role that community pharmacy plays”.

Source : C&D

Batches of Ventolin Accuhaler and Seretide Accuhaler asthma inhalers recalled

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Three specific lots of asthma inhalers are being recalled, including preventer and emergency relief inhalers.

People with asthma are being asked to replace specific batches of their Ventolin Accuhaler inhalers, used for the emergency relief of asthmatic symptoms. This is due to a manufacturing issue that results in a small number of the devices not delivering the full number of doses.

The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a patient level drug alert recalling two specific affected lots manufactured by Glaxo Wellcome UK Limited.

Patients who have used the affected batches of Ventolin may find that their symptoms are not relieved as normal by their Ventolin Accuhaler. If this happens, they should seek medical advice. Affected Accuhalers should be returned to their pharmacist for a replacement.

Additionally, one lot of Seretide Accuhaler, used for the maintenance of preventative treatment of asthma, is being recalled from hospitals, pharmacies, dispensing practices, retailers and wholesalers in the UK.

The recall of Seretide Accuhaler is pharmacy level because this is used for maintenance treatment as opposed to a reliever treatment.

The two affected batches of Ventolin Accuhaler and the one affected batch of Seretide were distributed to the UK market.

Only a small proportion of the units are defective (images below). Other asthma inhalers, including the more commonly used Ventolin Evohaler, are not affected.

Bernadette Sinclair Jenkins, MHRA’s Regulatory Assessment Unit Manager of the Inspections, Enforcement and Standards unit said:

It is important people check whether they have an affected inhaler. We want patients and their families to be confident treatment will be safe and effective when required.”

People with a Ventolin Accuhaler from the affected lots should take them to their pharmacy or their dispensing practice and speak to a pharmacist who will provide a replacement.

We strongly encourage anyone to report any issues with their inhalers or other medicines or medical devices to MHRA via our Yellow Card Scheme.

Information is also available to patients and healthcare professionals by contacting GSK’s Customer Support Team via customercontactuk@gsk.com or calling on 0800 221 441 (option 4).

Product Description Lot details Final market Expiry Date
Ventolin 200mcg – Accuhaler 1x60D 786G UK 05/2019
Ventolin 200mcg – Accuhaler 1x60D 754P UK 05/2019
Seretide 50/250mcg – Accuhaler 1x60D 5K8W UK 04/2019