(AGENPARL) - Roma, 14 Aprile 2023 - (AGENPARL) – ven 14 aprile 2023 14 April 2023
Media and Public Relations
News announcement
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.
The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the ‘Ongoing referrals’ table. Information on all topics discussed by the PRAC is available in the [agenda](https://link.mediaoutreach.meltwater.com/ls/click?upn=eR8gA2rSMGyvDZC4ShthtIfMhRs-2BEGfuPOqTkc00h0GfjgRiltESIhCE-2BU9cRfr86BWg5OHSBjmYro2hxqjgvsYdgutGIRRIykDPsNgDSYZhzvTeZODoBtmenKnFW-2FzGh8OaNT55Ib-2BafiE8aHzqPQ-3D-3DfJhz_mLoYh0p4AWg4foFr5HgrZ1QioQ33bLwdnQ-2BsYGKFX9mv8wVBOgi5GpVq-2FNhlrfTlX9L-2BS1vA2QXwHmqtsL-2BrQOvRw3CzioWUrjOOTPQmRkGlFdW82nbIfwPJFbqZt34s9IW7dised660UA7G5q0y0YLHew7dLR96X7DZ6eOuaYUbrs2wngAYcrjOc0fDgP-2F1NqRAzFd0mdxe2Cjbsy-2B-2FIy3GdOp-2FagXxiM42YlGNQq7bfv5-2BA02uJz0s1-2BXPVN346k3zW66Z2TAh7gUCGMl9OSyLyn4l6I1umXqwzqGHYCVlg74rTMQnTKU199ktME2ViennkgrKgC6VTJjK-2BnfsB6sHiITswKG2esXijo-2BNWQW-2BQQWjgqshd-2BUuts3RTkiZ8V44AqIPiYYFT4-2BzGyqmFg-3D-3D).
Ongoing referrals
Procedure
Status
Update
[Topiramate – Article-31 referral](https://link.mediaoutreach.meltwater.com/ls/click?upn=eR8gA2rSMGyvDZC4ShthtIfMhRs-2BEGfuPOqTkc00h0EwdDLDHEyn-2BJRfREriQSR7WxUtsD-2Fz7YdxByN-2BIRkf9Lb7n7DjKNXD3uquT-2F8AYUE-3DBaWd_mLoYh0p4AWg4foFr5HgrZ1QioQ33bLwdnQ-2BsYGKFX9mv8wVBOgi5GpVq-2FNhlrfTlX9L-2BS1vA2QXwHmqtsL-2BrQOvRw3CzioWUrjOOTPQmRkGlFdW82nbIfwPJFbqZt34s9IW7dised660UA7G5q0y0YLHew7dLR96X7DZ6eOuaYUbrs2wngAYcrjOc0fDgP-2F1NqRAzFd0mdxe2Cjbsy-2B-2FI4Qal-2Bf9Y4wMEILyGz3Gf66c82801iM2iP-2BPSz4CEDO1HdqCfeoRz3iiwLWyJP8B-2BspWnkZ0-2BSGjkD2UMiZ2-2Fe94u1eIEbXfQO32EL04-2FRlW0ZXRXyNjyK3KUlM4I2hNgl2gaA2JsXNxw6hO4KlMZgHap9-2FTjP5nK-2B2jwYu-2FAu8oTpVRwVOzf8cCw2xDT-2BGbVw-3D-3D)
Under evaluation
PRAC continued its assessment.
[Pseudoephedrine-containing medicinal products – Article – 31 referral](https://link.mediaoutreach.meltwater.com/ls/click?upn=eR8gA2rSMGyvDZC4ShthtIfMhRs-2BEGfuPOqTkc00h0EwdDLDHEyn-2BJRfREriQSR7WxUtsD-2Fz7YdxByN-2BIRkf9DPgUYtktWvZnlgydPfpnTSlqwc5yPOnXY2dvWTUNZloFPENEE-2F1OIBBUsKBKPZxuQ-3D-3DNWQW_mLoYh0p4AWg4foFr5HgrZ1QioQ33bLwdnQ-2BsYGKFX9mv8wVBOgi5GpVq-2FNhlrfTlX9L-2BS1vA2QXwHmqtsL-2BrQOvRw3CzioWUrjOOTPQmRkGlFdW82nbIfwPJFbqZt34s9IW7dised660UA7G5q0y0YLHew7dLR96X7DZ6eOuaYUbrs2wngAYcrjOc0fDgP-2F1NqRAzFd0mdxe2Cjbsy-2B-2FI4Lz2qmlo04HKXcn-2BQdqDQcEK289wBEbNOx5OQgpaxmE-2FOy3I7Z0L5tdqCXjRDnZJGXqzujloWp5EvQsIPiOGqACpjDfM33qnjac2N1gZ-2BBXy7lqPSualOvl39HBD5eHMug8dS4Desz3SDQ7ms4rl10M4IVBDvvFVtsWMUzXYjh8m3jfZx13LLiy3LfwsFeiag-3D-3D)
Under evaluation
PRAC continued its assessment.
Contact
EMA press office