PMDA drug package insert

シビレナE300

PMDA OTC drug · キューサイ株式会社 · package insert Jul 5, 2022

Key facts

Brand names シビレナE300
Companies 製造販売元/新日製薬(株),販売会社/キューサイ株式会社
Product type OTC drug
OTC risk class 第3類医薬品
OTC dosage form カプセル
OTC effect category ビタミンE主薬製剤
Package insert date Jul 5, 2022
PMDA document key 343020_K2104000020
PMDA company code 343020

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

Browse all PMDA approved drugs and package inserts (Japan)