EMEA grants marketing authorization to gefitinib for locally advanced or metastatic NSCLC with activating mutations of EGFR
28.04.09
Category: Scientific News
Highlights from the meeting of the EMEA Committee for Medicinal Products for Human Use
The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) at its meeting on 20–23 April 2009 adopted positive opinions, and recommend that marketing authorization be granted, for the following medicines:
Gefitinib – indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK. The EMEA review began on 28 May 2008 with an active review time of 210 days.
Fentanyl citrate – indicated as a nasal spray for the treatment of breakthrough pain in cancer patients who receive chronic opioid treatment to manage their background pain. The EMEA review began on 2 December 2007 with an active review time of 205 days.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου