This section lists details of new information added to the MHRA website.
24 Jul 2014 | GPC transactions of £500 and above during May 2014
GPC transactions of £500 and above during May 2014.
24 Jul 2014 | Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
The EMA have concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether the effectiveness of Levonelle (containing levonorgestrel) and ellaOne (containing ulipristal acetate) was reduced with increased body weight.
24 Jul 2014 | Press release: European review concludes positive benefit risk of emergency contraceptives
Emergency contraceptives continue to be suitable for all women who need them, regardless of the woman’s weight said the Medicines and Healthcare products Regulatory Agency (MHRA) today. These medicines may continue to be used to prevent unintended pregnancies and should be taken as soon as possible after unprotected intercourse or contraceptive failure. This follows a European review that concluded that the benefits of emergency contraceptives continue to outweigh the risks in all women.
24 Jul 2014 | Medical Device Alert: Surgical instrument: Standard Offset Cup Impactor manufactured by Greatbatch (MDA/2014/031)
This medical device alert is being issued due to the potential for infection from inadequately sterilized devices.
23 Jul 2014 | Expenditure transactions over £25k for June 2014
Details of all agency expenditure transactions of over £25k during June 2014.
23 Jul 2014 | Company-led drug recall: InductOs 12mg kit for implant reference 751090001 - Medtronic BioPharma B.V. - CLDA (14)A/12
Medtronic BioPharma B.V. is recalling a specific batch of InductOs 12mg kit for implant - reference 751090001, due to a sterility failure at the 24 month time point during a stability study for the Absorbable Collagen Sponge (ACS)
23 Jul 2014 | Medical Device Alert: Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and large) manufactured by DePuy Synthes (MDA/2014/030)
This Medical device alert is being issued as due to a change in instructions for use devices are now 'MR-Conditional', placing additional restrictions on patient positioning.
Some more information on the user research work that we are doing
22 Jul 2014 | Medical Device Alert: Ventstar disposable breathing systems manufactured by Draeger (MDA/2014/029)
This MDA is being issued as due to a manufacturing issue, there is the potential for loose adhesive residue to be inside the breathing systems.
22 Jul 2014 | Class 2 medicines recall (action within 48 hours): Amoxicillin Sodium 500mg Powder for Solution for Injection manufactured by Wockhardt UK Ltd (EL (14)A/11)
Further to the Class 4 ‘caution in use’ Alert issued on 9 July 2014, ref. EL (14)A/09, Wockhardt UK Ltd has received a small number of additional reports of injection site reactions in both paediatrics and adults. As a precaution, some batches of the 500mg presentation are now being recalled.