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CHMP highlights: September 2019
CHMP highlights: September 2019
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CHMP highlights: September 2019
CHMP highlights: September 2019
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its 16-19 September meeting.
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EMA to provide guidance on avoiding nitrosamines in human medicines
EMA to provide guidance on avoiding nitrosamines in human medicines
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EMA to provide guidance on avoiding nitrosamines in human medicines
EMA to provide guidance on avoiding nitrosamines in human medicines
EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
The PRAC starts review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis.
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
EMA and the European Commission provide additional information on exemptions for batch testing to help pharmaceutical companies prepare for the UK’s withdrawal from the EU.
