Aktualności
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
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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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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 16, 2015 concerning amendment of the Official List of Medicinal Products
26.03.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 16, 2015 concerning amendment of the Official List
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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 19, 2015 concerning the ID Registration Office in EudraVigilance system, which are sent to isolated cases of adverse reac
26.03.2015
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 19, 2015 concerning the ID Registration Office
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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 23, 2015 concerning content of Supplement 8.4 of eighth edition of European Pharmacopoeia (Ph. Eur.)
26.03.2015
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 23, 2015 concerning content of Supplement 8.4
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EMA: PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine
26.03.2015
European Medicines Agency\'s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a periodic review of one of the bisphosphonate medicines with a known risk of osteonecrosis of the
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EMA: PRAC recommends restrictions on the use of codeine for cough and cold in children
26.03.2015
European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of
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RAPS: FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex\'s Kaldeco
26.03.2015
The US Food and Drug Administration (FDA) has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products,
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RAPS: UK Regulator Issues First Positive Opinion in Early Access Program
26.03.2015
Merck’s new skin cancer treatment has become the first product approved under a new accelerated review process by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The
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FDA: Clinical Trial Imaging Endpoint Process Standards
19.03.2015
The purpose of this guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products.2 This
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