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Aquiette 2.5mg tablet:Reclassification as pharmacy medicine - 0 views

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    The Medicines and Healthcare Products Regulatory Agency (MHRA) is considering the reclassification of Aquiette 2.5mg tablets contains oxybutynin hydrochloride that is used to treat women with milder symptoms of overactive bladder from Prescription-Only-Medicine (POM) to Pharmacy (P) medicine. The agency is encouraging pharmacists, GPs and other health care professionals, the public and women to take part in the reclassification consultation to make a treatment for overactive bladder available for women without the need for a prescription. Public consultation on a set of proposals to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies will close on 13 May, 2022. It would be the first time a medicine for the treatment of overactive bladder would be available without prescription, if the reclassification consultation receives positive responses. After the decision is made to reclassify this treatment, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.
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MHRA Consultation: Codeine Linctus Reclassification to POM - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on the reclassification of codeine linctus to a prescription-only medicine after considering multiple Yellow Card reports for its opioid effects, rather than for its intended use as a cough suppressant. This medication is currently licensed as a pharmacy medicine, which means that it is available to purchase over the counter in pharmacies. If reclassified as a prescription-only medicine, all strengths of codeine linctus will only be available upon presentation of a prescription. Dr Alison Cave, MHRA Chief Safety Officer, said: "Codeine linctus is an effective medicine, but as it is an opioid, its misuse and abuse can have major health consequences. Every response received will help us to develop a broader view on whether codeine linctus should be restricted to prescription-only status. We want to hear from members of the public, health professionals and others who would be affected by this potential change so we can make a properly considered decision for the benefit of patients, carers, and healthcare professionals across the UK.
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Reclassification of Medicines: PAGB 40-Year Celebration - 0 views

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    Proprietary Association of Great Britain, PAGB - which represents manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements - on Tuesday (12 December) celebrated 40 years of reclassification of medicines. Expanding self-care for common ailments and minor injuries will not only help ease pressure on primary care services, but also provides significant potential savings for the NHS, the consumer healthcare association highlighted during the event. Nurofen (ibuprofen) and Imodium (loperamide) were the first medicines to go through Medicines and Healthcare products Regulatory Agency (MHRA)'s switch process in 1983 to make them available over the counter - OTC. Other reclassified medicines which were once available on prescription only include Voltarol (diclofenac dimethylammonium), Canesten (clotrimazole), Nexium (esomeprazole), Nicorette, Nicotinell and Niquitin (nicotine replacement therapies), Regaine (minoxidil), Viagra Connect (sildenafil), Cialis Together (tadalafil) for erectile dysfunction and Gina (estradiol hemihydrate) for the treatment of postmenopausal symptoms such as vaginal dryness.
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Aquiette 2.5mg Tablets to remain as prescription-only - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has maintained the prescription-only status of Aquiette 2.5mg Tablets for symptoms of overactive bladder, following a public consultation and the review of a reclassification application from the manufacturer Maxwellia Ltd. Aquiette, which contains the active ingredient oxybutynin, is used for the treatment of long-term symptoms of overactive bladder (OAB) in women aged between 18 and 65, such as the urgent need to urinate and frequent urination without pain. The regulator decided against the reclassification of Aquiette 2.5mg Tablets from a prescription-only medicine (POM) to a pharmacy (P) medicine, concluding that a medical prescription continues to be required to ensure the safe use of Aquiette. Since an OAB diagnosis requires medical supervision to ensure that the correct treatment is received, and other health conditions are not overlooked or left untreated, the MHRA said the decision would ensure that the medication is used safely and appropriately under medical supervision. "After taking on board the views of the many patients and healthcare professionals who responded, we have decided to refuse the reclassification of Aquiette 2.5mg Tablets for women with symptoms of overactive bladder (OAB)," Dr Laura Squire, MHRA chief healthcare quality and access officer, said.
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Maxwellia plans to switch products from POM to P medicine - 0 views

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    Maxwellia has revealed its plans to switch some of its medicines in the self-care category from prescription-only-medicine (POM) to a pharmacy (P) medicine. After authorising the switch of Maxwellia's two brands of desogestrel contraceptive pills, Lovima and Hana, MHRA has opened a public consultation on reclassification of Aquiette (overactive bladder treatment) 2.5mg tablets manufactured by the company to be made available from pharmacies. "Maxwellia is currently looking at a number of medicines which treat a range of conditions in major public health categories that can be 'switched' from needing a prescription to being conveniently bought at a local high street or supermarket pharmacy. With its foot firmly on the accelerator it has other applications under assessment with the MHRA, including women's health products," the company stated in a recent statement. "Push to convert more prescription medicines to pharmacy medicines will firmly position pharmacists at heart of nation's public health, helping futureproof NHS," the medicine said.
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Ian Adamson : Maxwellia appoints s Strategic Advisor - 0 views

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    Maxwellia has appointed Ian Adamson as strategic advisor to shape the next phase of pharmacy medicine launches - a process which involves identifying and converting suitable prescription only medicines into versions people can choose to buy under the supervision of a pharmacist. Ian brings over 30 years' international consumer health and personal care experience to the Maxwellia team. He is currently an advisor to the board of the UK independent pharmacy chain Day Lewis plc, an advisor to the board of Spanish healthcare company ReVa Europe S.L and board advisor to East Midlands Pharmaceuticals Ltd. Prior to this Ian was Chief Commercial Officer and a main board director at SSL International plc (prior to its sale to Reckitt Benckiser) with responsibility for a $1bn portfolio of brands, which included Durex and Scholl. Ian's appointment follows the landmark reclassification of the progestogen only pill by the MHRA, a change spearheaded by Maxwellia, and the company's subsequent launch of its first product Lovima in July 2021; and the current MHRA public consultation on the reclassification of Maxwellia's new pharmacy brand, Aquiette 2.5mg Tablets (Oxybutynin Hydrochloride) for the treatment of overactive bladder symptoms which are not adequately controlled by bladder training alone.
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Gina 10 : PAGB Backs Over-The-Counter Sale - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on plans to reclassify a locally-applied hormone replacement therapy product to treat the cause and relieve the symptoms of vaginal atrophy. The MHRA is proposing that Gina 10 microgram vaginal tablets, containing oestradiol, be made available over the counter as a "self care" product, under the supervision of a pharmacist. The Commission on Human Medicines too has advised that the application by Novo Nordisk, which is used to treat vaginal dryness, caused by oestrogen deficiency in postmenopausal women, can be made available as a pharmacy (P) medicine. The MHRA has been asking GPs, pharmacists and members of the public for their opinions on whether the tablets can be made available to women aged 50 and over who have not had a period for at least a year. If the reclassification goes ahead, pharmacists will be given training materials and a checklist to help them supply the medicine safely.
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HRA Pharma celebrates 1st anniversary of Hana - 0 views

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    HRA Pharma is celebrating the 1st anniversary of Hana, the first type of daily oral contraception available in the UK without a prescription. The launch of Hana in 2021 followed the historic decision of the Medicines and Healthcare products Regulatory Agency (MHRA) to grant a marketing authorisation and marked a significant step forward in the women's contraception category. The company reports that pharmacists have embraced the reclassification and have found merit in using emergency contraception consultations as an opportunity to educate women on their over-the-counter contraception options. Alison Slingsby, innovations project manager at HRA Pharma, commented: "We have been delighted with Hana's reception - within weeks of launch, it quickly became the best-selling mini-pill without prescription, with more than 95 per cent market share, and has maintained this market leading position ever since. We previously had the experience of switching emergency contraceptive ellaOne to a P medicine, Hana is on track to match and eventually exceed the ellaOne volumes.
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UK Drug Policy Overhaul Recommendations & Naloxone Access - 0 views

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    The Home Affairs Committee has called upon the government to revise its current drug policy, moving away from the exclusive 'abstinence only' approach towards a more practical strategy that highlights harm reduction. The HAC's recommendations also include the introduction of a national naloxone programme in England, with community pharmacies playing a central role in facilitating access. The committee published its comprehensive report on August 31, with key recommendations, including the 'urgent' reclassification of psychedelic drugs for therapeutic research; a pilot safe consumption facility program (long resisted by the Westminster Government despite Scottish lobbying); and enhanced provision and research on cannabis-based medicinal products (CBPMs). The report urged the establishment of a national naloxone programme in England, aligning with devolved nations. It also highlighted the role of community pharmacists and peer initiatives for effective distribution and administration. Furthermore, the report emphasises enhanced naloxone distribution for prison leavers. Naloxone is a medication capable of rapidly reversing heroin or methadone overdoses, potentially saving lives.
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