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The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing authorisation of Adtralza, a dermatological solution developed by Danish specialist LEO Pharma. This injectable solution contains 300 mg of tralokinumab in a 2 mL pre-filled pen and will be available for tralokinumab patients in the UK from early 2024. Tralokinumab is indicated for treating moderate-to-severe atopic dermatitis in adult and adolescent patients aged 12 and older who require systemic therapy, Leo Pharma said in a statement. It is a fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine. Previously, it was available in a 150 mg in 1 mL pre-filled syringe. According to Leo Pharma, the 300 mg tralokinumab in a 2 mL pre-filled pen offers a streamlined administration for both patients and prescribers. It begins with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose administered every other week. "We're pleased that this simplified administration method for tralokinumab will soon benefit eligible atopic dermatitis patients in the UK. It aligns with our commitment to elevate the standard of care and support for individuals with skin conditions," said Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked the pharmacies and wholesalers to stop supplying and quarantine all remaining stock of Dr Reddy's Laboratories (UK)'s Lacidipine 4 mg Film-Coated tablets. The company has recalled two batches of Lacidipine 4 mg Film-Coated tablets as a precautionary measure due to the presence of an unknown solvent-like odour. MHRA said: "The tablets are normally odourless. However, in the affected batches, a solvent-like odour is present when the individual blisters are opened. Additionally, some patient complaints have noted that the tablets have an unusual taste. The investigation to determine the root cause and to identify and quantify the odour is ongoing. "The issue is confined to batches B2202043 and B2202044 only. Other batches of Lacidipine 4 mg Film-Coated tablets marketed by Dr Reddy's Laboratories (UK) are not affected."

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Three batches of Mexiletine hydrochloride 50mg, 100mg and 200 mg hard capsules manufactured by Clinigen Healthcare has been recalled. Pharmacists are urged to quarantine the said batches and return it to the supplier by or before 12 August. Clinigen Healthcare Ltd has initiated a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of under dose or overdose, which could have consequences for the safety of patients. The manufacturer has confirmed that no alternative batches of Mexiletine hydrochloride 50mg, 100mg or 200mg hard capsules will be available until later in the year, therefore the recall of these batches from patients should only be considered where patients have access to appropriate alternative products. See below for more information on resupplying patients with alternative products. "Patients should be advised not to stop any treatments without consulting their relevant healthcare professional. The risks of suddenly stopping medication for ventricular arrhythmias is higher than the potential risk presented by too much or too little of the active ingredient in the capsule."

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution. Sanofi UK has recalled the batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of the manufacturer for vigabatrin. Sabril (vigabatrin) is indicated for adjunctive treatment of focal seizures with or without secondary generalisation not satisfactorily controlled with other antiepileptics (under expert supervision) and monotherapy in the treatment of infantile spasms (West's syndrome). All patients are advised not to discontinue Sabril tablets or Sabril granules without consulting with their prescriber. The risks of suddenly stopping medication for seizures/epilepsy is higher than the potential risk presented by the presence of tiapride. Sanofi UK have confirmed to DHSC that no other batches are impacted, and other stock remains available.

Women in the UK will be able to purchase Gina 10 mg vaginal tablets without prescription from September from their local pharmacies, announced the Medicines and Healthcare products Regulatory Agency (MHRA). The Hormone Replacement Therapy (HRT) product, Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period for at least one year. The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public consultation. The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists, the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.

In a significant leap forward in the fight against HIV, the Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to two groundbreaking formulations of cabotegravir. Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection are now authorized for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg at increased risk. This approval marks a pivotal moment in HIV (human immunodeficiency virus) prevention, offering an alternative to existing standard pre-exposure prophylaxis or PrEP treatments. HIV, a virus notorious for compromising the immune system, has long been a global health concern. Cabotegravir, a member of the integrase inhibitor group, works by blocking a key enzyme necessary for the replication of HIV-1, thereby reducing the virus's ability to spread.

Indian multinational pharmaceutical company, Dr. Reddy's Laboratories has made its entry into the UK consumer health market with the launch of an over-the-counter allergy medication. Histallay (Fexofenadine Hydrochloride 120 mg tablets) is the company's first general sale list (GSL) product introduced in the UK market. Previously classified as a Prescription Only Medicine (POM), Dr. Reddy's Fexofenadine 120 mg is now available without prescription, under the brand name 'Histallay'. This allows people with allergic seasonal rhinitis (hay fever) to get direct access to the product via retail outlets such as pharmacies and supermarkets in the UK.

The Department of Health and Social Care (DHSC) has issued a Serious Shortage Protocol (SSP) for Salazopyrin EN-Tabs 500 mg due to ongoing shortage of the medicine. With SSP014 in place from today (November 26), for every prescription one Sulfasalazine 500mg gastro-resistant (GR) tablet will be supplied. This SSP will expire on December 20, 2021, and PSNC will update contractors in case of any change. PSNC has advised pharmacists to notify the patient's prescriber while supplying in accordance with this SSP. Besides, the supervising pharmacist should refer back to the prescriber if a non-chewable atorvastatin tablet would not be appropriate for the patient.

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Considering the shortage of Fluoxetine 10mg tablets, the Department of Health and Social Care (DHSC) has extended the serious shortage protocol (SSP) for the medicine to February 11, 2022. Earlier the SSP for Fluoxetine 10mg tablets was set to expire on November 12. Extension of the transition period will enable use of No Cheaper Stock Obtainable (NCSO) endorsement and use of EPS tokens to claim for supplies made in accordance with SSPs. The NHS Business Services Authority (NHSBSA) has accepted that either the new 'SSP' or existing 'NCSO' endorsement for any SSP claims can be submitted using electronic prescriptions (EPS) tokens of FP10 paper prescriptions, during the period.

The price concession for Atorvastatin 80mg has been increased to £3.91 from the previously set £3.45 for prescriptions dispensed in July, the Community Pharmacy England has said. The Department of Health and Social Care additionally introduced a concession price of £3.38 for Atorvastatin 20mg. "In July, our Dispensing and Supply Team experienced an unusually high influx of reports from pharmacies struggling to acquire Atorvastatin 80mg tablets at the listed Drug Tariff price," said CPE. CPE requested a price concession early in the month. However, after extended discussions, an agreement on the price wasn't reached. Consequently, on July 31st, the DHSC imposed a concession of £3.45. Addressing enduring pharmacy concerns over the pricing, CPE intensified advocacy with DHSC. This endeavour resulted in the revision of the Atorvastatin 80mg tablet concession price to £3.91 for prescriptions submitted and dispensed in July. According to CPE, this adjusted price sufficiently covers costs as reported by the majority of pharmacy owners. However, DHSC has refrained from modifying concessionary prices for the other two requested lines by CPE. DHSC communicated that their team's data collection for July, employing real-time sales and volume data, was incongruent with the adjustment of these prices, CPE further said.

Thornton & Ross is all set to expand its consumer healthcare offering by acquiring the well-established Opticrom eye-drops brand from Sanofi in the UK. Opticrom forms part of a wider transaction between Thornton & Ross' parent group, STADA, and Sanofi for eight local consumer healthcare brands across several countries, including Belgium, Germany, Hungary, Spain and the UK. The transaction will be financed with a combination of cash on balance sheet and existing facilities, and is scheduled to close in the fourth quarter of 2023, subject to customary approvals of relevant regulatory authorities. Opticrom Allergy 10ml bottle and 20 single doses for itchy, watery, red and inflamed eyes can be found behind the pharmacy counter, while Opticrom Hayfever 10ml bottle is available to purchase via self-selection to soothe and relieve eye symptoms of hayfever. These non-prescription medicines contain 20 mg/1ml sodium cromoglicate (2.0% w/v) and offer relief within 2 minutes.

The Medicines & Healthcare products Regulatory Agency has initiated a recall of three batches of Quantum Pharmaceutical's Diltiazem HCl 2% Cream, which is an unlicensed medicine. MHRA issued a precautionary recall of the cream due to a change in the product's appearance that affected its thickness. Pharmacists are instructed to halt supply, quarantine remaining stock, and contact Quantum Pharmaceutical to return affected batches M1402497, M1402574, and M1402680. Patients using this product may encounter application issues with the cream due to its consistency. However, MHRA said that this has not impacted the product's effectiveness or posed any risk to patient safety. The MHRA also reported that medac GmbH (t/a medac Pharma LLP) is conducting a recall of two batches of Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) with batch numbers G220393B and G220393C. This class 2 medicines recall is a result of particles detected during long-term stability tests.

Atorvastatin, a medicine to treat high blood cholesterol, is the most dispensed drug with 59 million items in England in 2022/23, revealed the NHS Business Services Authority (NHSBSA) on Thursday (8 June). While Apixaban (an anticoagulant) was the drug with the highest costs of £430 million. Apixaban 5mg tablets had the largest increase in cost between 2021/22 and 2022/23 in England, with an increase of £280 million. NHSBSA's annual statistics report 'Prescription Cost Analysis-England 2022/23' published also has revealed an eight per cent rise in the prescription items that were dispensed in the community in England. The report highlighted that in 2022/23, 1.18 billion prescription items were dispensed at a cost of £10.4 billion in the community in England, witnessing an increase of eight per cent from £9.69 billion in 2021/22.

The widely-held concept that levels of "good" cholesterol in the blood can indicate heart disease risk is not equally true for Blacks and whites, and the measure itself may be of less value than previously thought, according to a U.S. study published on Monday (November 21). Various types of cholesterol are thought to have either healthy or unhealthy effects. Low levels of so-called "good" high-density lipoprotein (HDL) cholesterol were linked with higher odds for developing cardiac problems in the long-term study - but only in white participants, the study published in the Journal of the American College of Cardiology found. In contradiction to what has generally been assumed, low HDL levels did not confer any higher risk of heart disease in Black people, researchers said. Among white people, however, those with HDL levels below 40 milligrams per deciliter had a 22% higher risk for coronary heart disease compared with those whose HDL levels were higher. High HDL levels (above 60 mg/dL), which are thought to be protective, were not linked with lower coronary heart disease risks in either race, researchers found.

Department of Health and Social Care (DHSC) has issued a medicine supply notification for Oxcarbazepine (Trileptal) 300mg and 600mg tablets on Wednesday (14 June). It has notified that the Oxcarbazepine (Trileptal) 300mg tablets will be out of stock from late June 2023 until mid-July 2023 and Oxcarbazepine (Trileptal) 600mg tablets are out of stock until mid-July 2023. However, generic oxcarbazepine 300mg and 600mg tablets remain available and will be able to support increased demand. "Oxcarbazepine (Trileptal) 150mg tablets and generic oxcarbazepine 150mg tablets remain available but cannot support the increase in demand," said DHSC. "Oxcarbazepine (Trileptal) 60mg/ml oral suspension remains available but cannot meet an increase in demand."

The Department of Health and Social Care (DHSC) has included Tibolone 2.5mg tablets (Livial) and Prasterone 6.5mg pessaries (Intrarosa) to the list of Hormone Replacement Therapy (HRT). It has updated the June 2023 Drug Tariff (Part XVI) to include these additional HRT medicines for which patients will be able to purchase an HRT PPC. "HRT is the replacement of female sex hormones oestrogen and progesterone in women to control symptoms of the menopause. Some medicines that are converted or break down into oestrogen, progestogen or androgen hormones are prescribed for relief of menopausal symptoms. For the purposes of the HRT PPC these are included within this definition of HRT," said DHSC.