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PRAC
This page shows the latest PRAC news and features for those working in and with pharma, biotech and healthcare.
FDA rejects Allergan’s uterine fibroid drug over safety concerns
The findings were backed up by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that Esmya may have contributed to the development of some cases of serious liver injury.
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MHRA suspends new prescriptions of fibroid drug Esmya
In December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the treatment for abnormal bleeding in women with uterine fibroids after four cases of serious liver injury -
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Patient reporting rises after EU pharmacovigilance reforms
The 2012 reforms gave new powers to the EMA and created a Pharmacovigilance Risk Assessment Committee (PRAC) that helped to coordinate the activities of both the centralised agency and national regulatory ... Patient and healthcare professional
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Gilead's Zydelig passes EMA safety review
The PRAC has now updated recommendations for use to manage the potential problems. ... If patients suffer from a generalised infection, they should not begin treatment with Zydelig, PRAC says.
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EMA review clears GSK and Sanofi Pasteur MSD HPV vaccines
The regulator's Pharmacovigilance Risk Assessment Committee (PRAC) ruled out a connection between Cervarix and Gardasil and complex regional pain syndrome (CRPS) or postural orthostatic tachycardia syndrome (POTS). ... However, the EMA's
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EMA launches review of cervical cancer vaccine safety
The EMA said its pharmacovigilance risk assessment committee (PRAC) will now examine the available data on CRPS and PoTS to see whether there may be a causal link with HPV vaccination
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Changes to pharmacovigilance legislation in Europe
If the same safety concerns apply to more than one medicinal product, the competent authority may, following consultation with the Pharmacovigilance Risk Assessment Advisory Committee (PRAC), encourage the performance of a ... Among others activities,
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Dr June Raine continues as chair of EMA's pharmacovigilance committee
The PRAC also voted to extend Dr Almath Spooner's tenure asvice-chair. ... Under her leadership Dr Raine said the PRAC would have three key priorities:.
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EMA’s Pharmacovigilance Risk Assessment Committee gains new members
The European Medicines Agency's (EMA) newest committee - the Pharmacovigilance Risk Assessment Committee (PRAC) - has added two new members. ... Its new members Babylon and van der Zeijden will participate in the PRAC from April 2013.
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MHRA's Dr June Raine to chair new EMA pharmacovigilance committee
The PRAC will lead implementation of the wide-ranging pharmacovigilance reforms the EMA brought in over the summer. ... Dr Raine said: “The PRAC is set to play a pivotal role in delivering the public health benefits of the new European
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