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Class 4 Medicines Defect Information, AmBisome Liposomal 50 mg Powder for dispersion for infusion, (PL 16807/0001), EL (21)A/03
Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-K.
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Brief description of the problem
Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-K. The device manufacturer has informed Gilead that the filter lots packaged with the AmBisome batches listed in this notification may be releasing fibres and particles, which may pose a risk to the patient. There is no quality issue associated with AmBisome product and due to supply considerations, the product is not being recalled. Gilead Scienc
NICE guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible
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Mechelen, Belgium, 21 January 2021, 08:05 CET – Galapagos NV (Euronext & Nasdaq: GLPG) today welcomed the news that the
National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of the daily oral pill, JYSELECA
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▼ (filgotinib) on the National Health Service (NHS) in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).
1 It is the first time in the UK that an advanced therapy has been recommended in people with moderate RA, offering thousands more the potential to achieve remission earlier - potentially slowing the irreversible damage and life-limiting symptoms RA can cause.