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RAPS: EU Committee Confirms Increased Risk with Ibuprofen at High Doses

16.04.2015
A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient\'s risk for cardiovascular issues. ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 2, 2015 concerning a temporary interruption in the supply of medicinal products: Insuman Rapid, Basal and Comb (human insul

16.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 2, 2015 concerning a temporary interruption in the ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 8, 2015 concerning a additional measures taken to minimize the risk of osteonecrosis of the jaw caused by medicines contain

16.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 8, 2015 concerning a additional measures taken to ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 15, 2015 concerning a ibuprofen and risk of cardiovascular events large doses of the medicinal product

16.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 15, 2015 concerning a ibuprofen and risk of ...

RAPS: Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns

02.04.2015
A Thailand-based active pharmaceutical ingredient (API) manufacturer has been warned by the US Food and Drug Administration (FDA) for failing to ensure that its manufacturing data could not be ...

RAPS: EMA Updates its Biosimilar Insulin Guideline

02.04.2015
The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the ...

MHRA: Online learning module on reducing the side effects of steroid medicines to help clinicians to optimise the use of corticosteroids.

02.04.2015
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an online learning module on reducing the side effects of steroid medicines. The module will help clinicians to optimise ...

RAPS: An Argument for Emergency Authorization during Public Health Crises

02.04.2015
When a public health crisis like Ebola emerges, public health officials need the flexibility to respond quickly and effectively. But as a new paper in the journal Public Library of Science - ...

EMA: New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines

02.04.2015
Use to be avoided in patients at greatest risk and doses to be kept low The CMDh1 has agreed by consensus new measures to minimise the risk of effects on heart rhythm with medicines containing ...

EMA: Further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine

02.04.2015
Measures for other intravenous bisphosphonates and denosumab to be considered in upcoming reviews The European Medicines Agency (EMA) has completed a periodic review1 of Aclasta (zoledronic ...

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