Pharmaceuticals and Medical Devices Safety Information No. 314 July 2014 Executive Summary

Published by Translated by Pharmaceutical and Food Safety Bureau, Pharmaceuticals and Medical Devices Agency Ministry of Health, Labour and Welfare Office of Safety I

For full text version of Pharmaceuticals and Medical Devices Safety Information (PMDSI) No. 314, interested readers are advised to consult the PMDA website for upcoming information. The contents of this month's PMDSI are outlined below.

1. Revision of the Report Form in the Drugs and Medical Devices Safety Information Reporting System The Act for partial amendment of the Pharmaceutical Affairs Act and the Pharmacists Act (Act No. 103, 2013) has been implemented, and the Drug Safety Information Report Form was revised. Information on the revision will be summarized in section 1 of the full text.

2. Revision of Precautions (No. 257) Revisions of Precautions for the following pharmaceuticals: Azilsartan, Azilsartan/Amlodipine Besilate, Irbesartan, Irbesartan/Amlodipine Besilate, Irbesartan/Trichlormethiazide, Olmesartan Medoxomil, Olmesartan Medoxomil/Azelnidipine, Candesartan Cilexetil, Candesartan Cilexetil/Amlodipine Besilate, Candesartan Cilexetil/Hydrochlorothiazide, Valsartan, Valsartan/Amlodipine Besilate, Valsartan/Cilnidipine, Valsartan/Hydrochlorothiazide, Losartan Potassium/Hydrochlorothiazide, Alacepril, Imidapril Hydrochloride, Enalapril Maleate, Captopril, Quinapril Hydrochloride, Cilazapril Hydrate, Temocapril Hydrochloride, Delapril Hydrochloride, Trandolapril, Benazepril Hydrochloride, Perindopril Erbumine, Lisinopril Hydrate, Telmisartan, Telmisartan/Amlodipine Besilate, Telmisartan/Hydrochlorothiazide, Losartan Potassium, Rosuvastatin Calcium, Imidafenacin, Nartograstim (Genetical Recombination), Filgrastim (Genetical Recombination), Filgrastim (Genetical Recombination) (Filgrastim Biosimilar 1), Filgrastim (Genetical Recombination) (Filgrastim Biosimilar 2), Filgrastim (Genetical Recombination) (Filgrastim Biosimilar 3), Lenograstim (Genetical Recombination)

3. List of Products Subject to Early Post-marketing Phase Vigilance (as of July 2014) A list of products subject to Early Post-marketing Phase Vigilance as of July 1, 2014 will be provided in section 3 of the full text.

This English version of PMDSI is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA shall not be responsible for any consequence resulting from use of this English version.