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19 Nov 2019, 12:33 pm by Tom Lamb
From the first part of an EMA document titled "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019", here is a summary of the PRAC Lemtrada restrictions proposal: EMA’s safety committee (PRAC) recommended restricting Lemtrada for use in adults with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly… [read post]
14 Oct 2014, 11:17 am by Tom Lamb
From an October 14, 2014 Medscape news report, "Restrict Valproate, EMA Committee Urges": The European Medicine Agency (EMA)'s Pharmacovigilance and Risk Assessment Committee has recommended strengthening the restrictions on the use of valproate in women of childbearing age. [read post]
11 Sep 2010, 1:23 pm by Tom B
EMA case, I figured a post was in order in case there were some folks out there curious about WTF is going on. [read post]
5 Jun 2014, 9:05 am by Tom Lamb
From this May 8, 2014 EMA Announcement, "Review of hydroxyzine-containing medicines started": The review was requested by the Hungarian medicines agency (GYEMSZI-OGYI) over concerns about the side effects of these medicines on the heart. [read post]
14 Jul 2020, 12:20 pm by Tom Lamb
It seems plausible that Health Canada may reach the same conclusion as the EMA did in April 2020, which is that the Picato skin cancer risk outweighs Picato's benefits as a treatment of actinic keratosis. [read post]
18 Nov 2022, 6:50 am by Stephen Honig
Six years ago Dell Technologies financed its multi-billion dollar acquisition of EMC Technologies by issuing a special class of “V” shares. [read post]
12 Feb 2020, 7:22 am by Jonathan Radcliffe
EMA (C-175/18 P) and MSD Animal Health Innovation and Intervet International v EMA (C-178/18 P), the decision was upheld to grant access to documents containing information submitted as part of medicinal product marketing authorisations (MA) applications. [read post]
13 Apr 2009, 8:15 am
” The FDA hopes to raise awareness about EMA and receive input regarding how industry and regulators can predict, prevent, and address EMA. [read post]
22 Apr 2012, 3:05 pm by Bryan Fears
  The EMA isn’t the only governmental agency concerned about the effects of Actos. [read post]
20 Mar 2018, 5:45 am by Howard Bashman
“The Supreme Court Will Decide Whether California Can Require ‘Crisis Pregnancy Centers’ To Post Information On Abortions”: Ema O’Connor and Zoe Tillman of BuzzFeed News have this report. [read post]
14 Jan 2019, 9:58 am by Howard Bashman
“Trump’s New Birth Control Rules Are Going Into Effect In A Majority Of States Following A Judge’s Limited Ruling”: Ema O’Connor of BuzzFeed News has this report. [read post]
25 Jan 2014, 3:20 am by Reproductive Rights
TIME: Effectiveness of Emergency Contraception for Overweight Women Reviewed in Europe, by Alexandra Sifferlin: The European Medicines Agency (EMA) — the European version of the U.S. [read post]
13 Mar 2018, 11:33 am by Howard Bashman
“An Undocumented Teen At The Center Of A Suit Against The Trump Administration Said She Doesn’t Want An Abortion After All”: Ema O’Connor and Zoe Tillman of BuzzFeed News have this report. [read post]
11 Jan 2018, 12:12 pm
"Another Undocumented Teen Says The Trump Administration Is Blocking Her From Getting An Abortion": Ema O'Connor of BuzzFeed News has this report. [read post]
18 Jul 2023, 11:45 am by Tom Lamb
The EMA’s investigation centers on medicines that contain either semaglutide or liraglutide. [read post]