Notice to marketing authorisation holders on the update of Appendix V
11.05.2017
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Pharmacovigilance
Recommendations for reporting variations in medicinal product documentation based on the safety signal review from the PRAC meeting held in April 2017
03.05.2017
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Direct healthcare professional communication on updates to strength expression, dose regimens in deep vein thrombosis / pulmonary embolism and use in patients with severe renal impairment for Clexane (enoxaparin sodium)
28.04.2017
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Meeting highlights from the CHMP meeting in April 2017
28.04.2017
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Meeting highlights from the CMDh meeting in April 2017
28.04.2017
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Direct healthcare professional communication on the recall of potentially impacted lots of EpiPen 0.3 mg solution for injection and EpiPen Junior 0.15 mg solution for injection (epinephrine) due to potential defects in auto-injectors
14.04.2017
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Direct healthcare professional communication on the important additional warnings for hemorrhage and rhabdomyolysis with Cotellic (cobimetinib), including new dose modification recommendations
14.04.2017
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Meeting highlights from the PRAC meeting in April 2017
10.04.2017
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Meeting highlights from the CMDh meeting in March 2017
03.04.2017
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Meeting highlights from the CHMP meeting in March 2017
30.03.2017
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