Category Archives: UK Pharma

EDQM suspend Mylan laboratories Valsartan license

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Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.

European Directorate for the Quality of Medicines has now suspended the manufacturer’s CEP, effectively prohibiting the use of its valsartan in EU medicines.

In addition, national authorities in the EU have started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination.

NDEA and the related compound N-nitrosodimethylamine (NDMA), which have been seen in ‘sartans’ from other manufacturers, are classified as probable human carcinogens (substances that could cause cancer).

Companies marketing sartan medicines in the EU have been asked to test their products for these impurities. Additional testing is being carried out by EU laboratories. The European Medicines Agency will update the public as soon as new information becomes available.

 

Source: EMA

 

Class 4 medicines defect information: Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046

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Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)

Product information

MDR number

MDR 147-09/17

Company name

Kyowa Kirin

Product description

Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU (Bleomycin sulfate)

PL number

PL 16508/0046

Batch number Expiry date Pack size First distributed
Y7B290 Oct 2020 10 Jun 2018

Brief description of the problem

In April 2017, glass particles were detected in a batch of Bleo-Medac (bleomycin sulfate) from the same manufacturer.

Advice for healthcare professionals

While investigations are ongoing, additional measures should be adopted:

  • follow all the recommended steps for the preparation of Bleo-Kyowa in accordance with the Summary of Product Characteristics
  • carefully inspect the reconstituted product under a bright light
  • if particulate or glass matter is visible after reconstitution, do not administer the product to patients. Please retain the vial, quarantined safely away from other stock and notify the marketing authorisation holder
  • if there is no visible particulate matter after reconstitution, the use of a standard 5-micron (5 µm) filter needle to withdraw the reconstituted product from the vial prior to administration is recommended as glass particles may be difficult to see

Background

In April 2017, reports of glass particles in a batch of Bleo-Medac Powder for Solution for Injection, 15,000 IU, resulted in recall in some European countries. No recall action was necessary in the UK as the affected batch had not been distributed in the UK.

The marketing authorisation holder continues to investigate the root cause of this quality defect. To maintain continuity of supply in the UK, the marketing authorisation holder will distribute new batches of Bleo-Kyowa that meet current specifications.

Company contact information

Kyowa Kirin Medical Information

Tel: +44 (0)1896 664000

medinfo@kyowakirin.com

Valproate banned without the pregnancy prevention programme

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Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP).

To protect public health, the Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines (Epilim, Depakote and generic brands). Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP).

Valproate is a treatment for epilepsy and bipolar disorder. Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders. 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.

Healthcare professionals who seek to prescribe valproate to their female patients must make sure they are enrolled in the PPP. This includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.

All women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed. No woman or girl should stop taking valproate without medical advice.

These regulatory changes will be further supported in the upcoming months by:

smaller pack sizes to encourage monthly prescribing
a pictogram/warning image on valproate labelling
These new regulatory measures are being supported across the NHS with other authorities also making changes – such as new GP system computer alerts – to make sure changes in prescribing behaviour take place promptly. NHS Digital has worked with GP systems suppliers to provide a search and audit function to identify women and girls on valproate as well as updating valproate prescribing alerts. A letter will be sent to all relevant healthcare professionals in the coming weeks outlining the new requirements and providing updated educational materials.

In parallel, the National Institute for Health and Care Excellence (NICE) is amending its guidelines where valproate is mentioned, to reflect the new regulatory position. NICE has also begun work on a full update of its guideline on epilepsy. This will specifically focus on areas where valproate is currently regarded as the drug of choice and where this conflicts with the new position.

Working together, across the health sector, these measures will help reduce the number of pregnancies exposed to valproate medicines to an absolute minimum and will make sure all women and girls of childbearing potential are aware of the risks.

Since it was introduced in 1974, the information provided with valproate included a warning about the possible risk of birth defects. As with all medicines, the safety of valproate has been kept under constant review and as new data have become available, and the magnitude and the nature of the risks were better understood, warnings were updated – resulting in this most recent regulatory change.

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

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 vitally 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 involved in the Valproate Stakeholder Network who have shared their experiences and expertise with us. Their support will help keep future generations of children safe.

Health Minister Lord O’Shaughnessy said:

Our priority is always patients’ safety, so I welcome this decision to take strong actions to protect women and children.

The focus will now be on explaining these changes to GPs and clinicians so they in turn can advise patients.

Professor Mark Baker, director of the Centre for Guidelines at NICE, said:

NICE welcomes restricting the use of valproate in women of childbearing potential.

It’s important that everyone affected by these changes is made aware of them as soon as possible. We have therefore taken immediate steps to amend our guidelines on the diagnosis and management of epilepsies, the assessment and management of bipolar disorder, depression in adults, and antenatal and postnatal mental health to reflect this important change to the drug’s licence.

We will use our communications networks to highlight the changes, both to healthcare professionals and to patients, to help ensure that the number of children exposed to valproate through their mother during pregnancy is kept to an absolute minimum.

Nic Fox, director of Primary and Social Care Technology at NHS Digital said:

This is a good example of how IT systems can support important issues affecting public health. We have been working closely with the MHRA and GP system suppliers to ensure clinicians in primary care are informed of the risks of prescribing sodium valproate to certain patients.

All GP systems have alerts applied and we are continuing to work with some of the suppliers to ensure these high visibility alerts are consistent across primary care. These alerts ensure that GPs are prompted at the time of prescribing.

We have also worked with community pharmacy dispensing system suppliers to ensure that the alerts are also shown when prescriptions are dispensed. This includes changes to prescription labels so that patients are made aware of the risks and the need for reliable contraceptive precautions. We will continue to work with supplier partners in evolving system to maximise safety and minimise burden on clinicians and patients as guidance evolves.

Matthew Jolly, National Clinical Director for maternity and women’s health at NHS England, said:

Stronger regulation over the use of valproate is welcome and will help ensure women get the advice and care they need. It is important pregnant women discuss their medication with their doctor and crucially do not stop taking it before seeking advice.

Mr Edward Morris, vice president for clinical quality at the Royal College of Obstetricians and Gynaecologists, said:

We welcome this action to reduce the risk of physical and developmental problems in children born to mothers who have taken valproate during pregnancy. Our clinical guideline on the management of epilepsy in pregnancy recommends that exposure to sodium valproate and other anti-epileptic drugs should be minimised by changing the medication prior to conception, as recommended by an epilepsy specialist after a careful evaluation of the potential risks and benefits.

It’s important to note that stopping medication for long-term conditions completely or altering the dose can pose a serious risk to both mother and baby. Women are advised to seek advice from their GP and/or specialist team before conception or as soon as they are aware that they are pregnant. For women with epilepsy, the lowest effective dose of the most appropriate anti-epileptic drug should be prescribed and they should be looked after by a specialist team throughout pregnancy.

Professor Helen Stokes-Lampard, chair of the Royal College of GPs, said:

GPs are acutely aware of the risks associated with prescribing sodium valproate to women of childbearing age and we welcome this change in legislation as a logical way forward to help ensure our patients’ safety. However, any patients currently taking sodium valproate should not stop doing so without seeking expert medical advice.

As a general rule, it is important that patients read and take heed of warnings on the packets of any medication they are taking – and that any woman on long-term medication speaks to their GP if they are planning to have a baby.

Carol Long, chief executive of Young Epilepsy, said:

Young Epilepsy welcomes the MHRA’s strengthened regulatory position for women of childbearing potential, who are diagnosed with epilepsy and prescribed sodium valproate. In ensuring such women receiving a Pregnancy Protection Plan (PPP), they will have greater knowledge in realising the potential risks taking the drug has to the unborn child.

It is vital that women who may be planning to have a family receive the right advice at the right time; to prevent their unborn babies being put at risk.

Sodium valproate can provide life-changing support for many young people with epilepsy. It is the third most-prescribed anti-epilepsy medication, however, the percentage of women who do not know the risks of taking the drug during pregnancy is far too high. That information must be made clearer, and medical professionals must be given more support to understand and be proactive in flagging the risks. Women must feel more empowered to discuss the issue with their epilepsy specialist, so that they can make a more informed decision about their future.

Simon Wigglesworth, deputy chief executive of Epilepsy Action, said:

We welcome the revised measures which reflect the seriousness of the risks to the unborn children of women with epilepsy during pregnancy. Despite previous interventions, we know there are still far too many women who haven’t been made aware of the potential risks of taking sodium valproate in pregnancy.

It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines. We are working closely with the MHRA on the implementation of these new guidelines and will be looking to see if meaningful progress will be made in avoiding life-changing harm to children born to women with epilepsy.

Clare Pelham, chief executive of Epilepsy Society, said:

The most important change today is that every woman and girl of childbearing age who has been prescribed sodium valproate will be able to see her doctor every year to discuss the risks of this drug to an unborn baby. She will leave the discussion with an important written reminder of the risks if sodium valproate is taken during pregnancy. This means that she will be able to make informed choices about whether to plan a pregnancy and her future medical treatment.

It has taken many years to achieve these simple, straightforward and inexpensive healthcare improvements that will prevent babies being born with avoidable disabilities. All credit to the brave women who have campaigned for decades. And to Jeremy Hunt for acting on that campaign and insisting the NHS must now learn from its failure to listen and act sooner in response to the concerns raised over many years and during many governments. At Epilepsy Society we shall be diligently monitoring the implementation on the ground in order to confirm that it is robust and effective.

Stephen Buckley, head of Information at Mind, the mental health charity, said:

We welcome the new rules around prescribing valproate to women of childbearing age. It is essential the information about the changes reaches both the public and professionals, and that any women taking valproate are properly supported to come off the medication safely. Mind’s website has updated information about what these changes mean – visit mind.org.uk for details.

Emma Friedmann, campaign director of #FACSaware, said:

FACSaware are absolutely delighted with the new measures as this will enable women to have an informed choice.

We look forward to continuing our work with the MHRA to promote the importance of the Central Alerting System and the Yellow Card ADR reporting scheme.

We are confident that fewer children will be born with this avoidable syndrome. By working with stakeholders we are definitely achieving our objectives.

Carol Lapidge & Susan Cole, OACS (Organisation for Anti-Convulsant Syndrome) Charity, said:

OACS Charity welcomes the prevention measures agreed by MHRA who have consulted with us alongside other campaign groups over the past two years. Since January 2016 OACS Charity has attended every meeting of the Valproate Stakeholder’s Network and we are appreciative that the MHRA has developed this progressive forum for discussion.

Next year OACS will be celebrating 20 years supporting and representing families affected by fetal valproate syndrome and we are pleased that the MHRA has developed this progressive forum for discussion.

Their work with stakeholders has resulted in inclusive and constructive engagement with groups across the UK health, science and digital sectors alongside patient groups. This has been a difficult but hugely constructive journey.

We believe that this process, led by June Raine, will pave the way for other groups who have been adversely affected by medicines in the past.

If you have been affected by sodium valproate please see our website oacscharity.org.

Janet Williams & Emma Murphy, INFACT, said:

INFACT welcome the changes made to the licence for Valproate and are pleased and very proud to have instigated and helped drive this forward following 6 years campaigning at Parliament for those changes.

It is important that all women prescribed Valproate are made aware of the risks when taken in pregnancy in order to safeguard their future children from disabilities, and INFACT applaud the decision made by the MHRA to ensure that risk is minimal.

Karen Keely, chairperson of OACS Ireland, said:

OACS Ireland welcomes the new regulatory measures by MHRA Epilim (Valproate) UK Toolkit. Women and men were prescribed this drug as far back as 1973 in the UK with many children harmed worldwide.

OACS Ireland welcomes the MHRA efforts to make changes to the way valproate is prescribed to prevent further harm. They brought their concerns to the attention of the EMA and therefore to all EU Nations including Ireland. By ensuring that the Epilim (Valproate) toolkit is securely put in place alongside Pregnancy Prevention Program (PPP) we hope to ensure this is followed by all.

We have been working with MHRA for many years now and hope to assist them with their work as much as possible by ensuring the valproate toolkit is followed. We hope that the new guidance will be followed by all. As part of the stakeholder’s network group run by the MHRA which has resulted in inclusive and constructive engagement with groups across the UK and Ireland’s health, science and digital sectors alongside patient groups. Although this process has been a difficult it has been hugely constructive.

Without the UK MHRA contributions to the EMA many mothers would not have known the risks of this drug.

On behalf of the Association of British Neurologists (ABN) by Professor Mary M Reilly, President, and Professor Sanjay Sisodiya, Chair of the ABN Epilepsy Advisory Group, said:

The ABN welcomes these important new measures. It is vital that all neurologists are aware of the changes to the licensing of valproate. We will disseminate information around the new measures to our membership through our publications, website and bulletins. We will also include links to a variety of resources and organisations, including support groups, and remind our membership about the Epilepsy and Pregnancy Register.

It cannot be stressed enough that no women should stop taking this medication without medical advice.

Dr Angelika Wieck, Royal College of Psychiatrists Perinatal Faculty and Consultant Psychiatrist, Central Manchester University Hospital, said:

Valproate can cause harm to unborn children so banning its use in women with mental disorder who are pregnant, or could get pregnant, is welcome. It cannot be stressed enough that no women should stop taking this medication without medical advice.

Managing mental health is particularly important for women who are pregnant or plan to get pregnant. It is essential that all women are better informed about the risks of Valproate to unborn children and that any use of this drug in pregnancy will be monitored.

RCPsych will work with the MHRA and other Government bodies, the Royal Colleges of General Practitioners, Physicians, Obstetricians and Gynaecologists and the Royal Pharmaceutical Society to implement changes in clinical practice and support affected women.

Rachel Scanlan, professional advisor at the Royal College of Midwives, said:

These are very welcome measures that will enable midwives to advise and support women about this issue. We are actively putting this information out to our members including on social media and via the RCM’s website so that our members are informed about this important update. We have also updated our online learning package on epilepsy and pregnancy to reflect these changes.

Professor Ash Soni, president of the Royal Pharmaceutical Society, said:

The Royal Pharmaceutical Society fully supports these new measures to ensure women understand the risks of taking sodium valproate during pregnancy. They must get the right information from health professionals in order to make informed choices about their health and parenting options. Valproate is an effective medicine and women should never suddenly stop taking it without talking to a health professional. Pharmacists are ideally placed to give information and support when providing sodium valproate and are committed to reducing harm from medicines, enabling women to make the choices that are right for them.

Dr Asha Kasliwal, president of the Faculty of Sexual and Reproductive Healthcare (FSRH), said:

FSRH welcomes the new regulatory measures on sodium valproate medicines introduced by the MHRA. Evidence is clear that children born to women who take valproate during pregnancy are at a significant risk of birth defects and developmental disorders.

Some of these drugs can affect how well some contraceptive methods work. However, women and girls who need these life-changing medications do not have to be left at risk for unplanned pregnancies. Our 2017 clinical guidance on drug interactions with hormonal contraception recommends that women and girls taking sodium valproate use highly-effective methods of contraception to avoid an unplanned pregnancy, both during treatment and for the recommended timeframe after discontinuation.

Methods of contraception which are considered highly effective in this context include long-acting reversible contraceptives (LARCs) such as the copper IUD, levonorgestrel intrauterine system (LNG-IUS), the progestogen-only implant (IMP) and sterilisation. Women should seek advice from a specialist, who will carry out a pregnancy risk assessment and provide evidence-based advice on the most suitable method for them.

In February this year, FSRH issued a clinical statement on contraception for women using known teratogenic drugs such as valproate, which is intended to support clinicians in providing high quality and consistent contraceptive advice. FSRH will keep working with its members to ensure they are aware of the MHRA decision and can advise women accordingly.

Merck sells consumer healthcare unit to P&G

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Germany’s Merck is selling its consumer health unit to Procter & Gamble for around for 3.4 billion Euros.

Merck said last year that is was mulling over the future of its consumer health division, and that a sale would help it execute its science and technology focused strategy.

Stefan Oschmann, chairman of the executive board and Merck’s chief executive, said the move “is a clear demonstration of our continued commitment to actively shape our portfolio as a leading science and technology company.”

“Consumer Health is a strong business that deserves the best possible opportunities for its future development. With P&G we have found a strong, highly recognised player who has the necessary scale to successfully drive the business going forward.”

Merck said sales from its consumer health unit grew organically by 6 percent between 2015 and 2017, “outpacing the consumer health market’s growth of approximately 4 percent over the same period”. The business pulled in new sales of around $911 million last year.

“We like the steady, broad-based growth of the OTC healthcare market and are pleased to add Merck’s Consumer Health portfolio and people to the P&G family,” added David Taylor, P&G Chairman of the board, president and chief executive.

The transaction, which is expected to close by the end of the fourth quarter 2018, is subject to regulatory approvals and other customary closing conditions.

As part of the transaction, around 3,300 employees are expected to transition to P&G, subject to prior works council consultation where required.

 

Source – Pharma Times

Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07)

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Product information
MDR number

MDR 049-12/17

Company name

Techdow Europe AB

Product description

Inhixa solution for injection in pre-filled syringe 2,000 IU (20 mg) in 0.2 mL; 4,000 IU (40 mg) in 0.4 mL; 6,000 IU (60 mg) in 0.6 mL; 8,000 IU (80 mg) in 0.8 mL; 10,000 IU (100 mg) in 1.0 mL.

Marketing Authorisation number

EU/1/16/1132/012
EU/1/16/1132/014
EU/1/16/1132/016
EU/1/16/1132/018
EU/1/16/1132/020

Brief description of the problem

Techdow Europe AB has issued the Direct Healthcare Professional Communication (DHCP) attached due to rare cases of premature self-activation of the safety device in unused, unopened pre-filled Inhixa syringes as shown in the DHCP diagrams. When premature activation has occurred, administration is not possible.
Advice for healthcare professionals

To minimise the risk of missed doses:

Pharmacists should visually check all Inhixa syringes before dispensing to check if they are affected by the self-activation defect as shown in the DHCP diagrams. Do not open the syringe blisters.
Individual syringes that are affected by the self-activation defect should not be dispensed to patients.
Pharmacists should make sure they have sufficient stock of Inhixa available as replacements.

Manufacturing issues stoke fears of EpiPen shortage in Britain

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Manufacturing problems have created a shortage of Mylan’s EpiPens in Britain, forcing the company to ration the devices allergy patients rely on to treat anaphylactic shock.

The company announced it will ration the devices, which contain doses of adrenaline, the Daily Mail reported. A spokesperson for the company told the newspaper the shortage is the result of manufacturing delays at a subsidiary firm owned by Pfizer. Mylan has previously warned of global supply issues with the device.

The spokesperson, who was not named, told the the Daily Mail the company is currently unable to determine “when the supply constraint will be fully resolved.”

An unnamed Pfizer spokesperson said, “We understand how important this potentially life-saving product is to patients,” adding that it is “working tirelessly to increase production and expedite shipments as rapidly as possible.”

The shortage could affect tens of thousands of patients in the country.

EpiPen competitors Bausch+Lomb, maker of Emerade, along with Denmark’s ALKAbelló, maker of Jext, are rushing to make up the shortfall of the treatment, the newspaper said.

Last summer, Mylan came under intense criticism for its repeated price hikes on EpiPen, which had taken the lifesaving injector’s list price up several hundred percent over previous years. As a result of the controversy, Mylan beefed up its patient access program and rolled out a cheaper authorized generic.

Source: Fierce Pharma

Mesna 100mg/ml solution for injection/infusion, 5 x 4ml – Product Recall

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Claris Lifesciences UK Limited are issuing a company-led drug alert for one batch of Mesna 100mg/ml solution for injection/infusion, 5 x 4ml due to stability issues (CLDA (18)A/01)

Product information

CLDA number

CLDA (18)A/01

MDR number

101-03/18

Company name

Claris Lifesciences UK Limited

Product description

Mesna 100mg/ml solution for injection/infusion, 5 x 4ml

PL 20568/0044

Batch Number/Expiry

Batch No. Expiry date
B560240 April 2019

Claris Lifesciences UK Limited is recalling the above batch due to stability issues.

 

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