Olumiant re-examination period extended by 35 months
By Lee, Hye-Kyung | translator Kim, Jung-Ju
23.09.16 05:50:23
In March of this year, the post-sales investigation (PMS) plan of Lilly Korea Olumiant, which was approved for severe circular alopecia indications in adult patients over the age of 18 from the Ministry of Food and Drug Safety in March of this year, will also be changed. According to the minutes of the meeting of the Central Pharmaceutical Review Committee held on August 16th and 18th, which was recently released by the Ministry of Food and Drug Safety, it was concluded that it is reasonable to extend the investigation period and change the subject in consideration of the current status of the usability permission to change the indication of the target after the market. The original PMS period was six years, but thi
Lee, Hye-Kyung(hgrace7@dailypharm.com)