PMDA drug package insert

サンリズム注射液50

PMDA Prescription drug · 第一三共株式会社 · package insert Mar 11, 2026

Key facts

Brand names サンリズム注射液50
Nonproprietary names ピルシカイニド塩酸塩水和物
Companies 製造販売元/第一三共株式会社
Product type Prescription drug
Therapeutic category 不整脈治療剤
Therapeutic category codes 872129
YJ codes 2129408A1020
Approval numbers 21200AMZ00021
Package insert edition 第2版
Package insert date Mar 11, 2026
PMDA document key 430574_2129408A1020_3
PMDA company code 430574

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes 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)