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- Read more about EMA to issue electronic certificates for medicines
EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates but only electronically signed and authenticated certificates to maintain EMA’s ability to provide these documents during the COVID-19 pandemic.
- Read more about EMA Update on treatments and vaccines against COVID-19 under development
Supporting the rapid development and approval of effective and safe treatments for and vaccines against COVID-19 is EMA’s top priority to help save lives during the pandemic. Over recent weeks and months, the Agency has engaged with many developers of therapeutic medicines and there are a number of developments underway. However, at this point, on the basis of the preliminary data presented to the Agency, no medicine has yet demonstrated efficacy in treating COVID-19.
- Read more about Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening
Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is being recalled due to product complaints received due to ampules breaking and shattering, upon opening, during compounding.
- Read more about Johnson & Johnson to initiate Clinical Studies of COVID-19 Vaccine
- Read more about CCMB may soon come up with diagnostic kits for Covid-19
To combat Covid-19 pandemic, the World Health Organisation (WHO) insists that widescale “testing, testing, and testing” is the key as early diagnosis may help save lives. Aligning with the call of WHO, the Centre for Cellular and Molecular Biology (CCMB) is working overtime on the development of cost-effective and accurate diagnostic kits for wide distribution.
- Read more about EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic
EMA is aware of recent media reports and publications which question whether some medicines, for instance angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines), could worsen coronavirus disease (COVID-19). ACE inhibitors and ARBs are most commonly used for treating patients with high blood pressure, heart failure or kidney disease.
- Read more about EMA Recommend to restrict use of fosfomycin antibiotics
EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent infection in men who undergo a procedure whereby a tissue sample is taken from their prostate (biopsy).
- Read more about EMA committee Restrict the use of cyproterone due to meningioma risk
EMA’s safety committee (PRAC) recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Once higher doses have started working, the dose should be gradually reduced to the lowest effective dose.
- Read more about New gene therapy to treat spinal muscular atrophy
EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.
- Read more about Indian scientist designed potential vaccine candidate for new corona virus
Indian Researcher from University of Hyderabad has developed potential vaccine candidate for COVID-19 (novel corona virus). The potential vaccine candidate is active against all the structural and non-structural proteins of COVID-19.