PMDA drug package insert

キシロカイン注射液「0.5%」エピレナミン(1:100,000)含有

PMDA Prescription drug · サンドファーマ株式会社 · package insert Apr 13, 2026

Key facts

Brand names キシロカイン注射液「0.5%」エピレナミン(1:100,000)含有, キシロカイン注射液「1%」エピレナミン(1:100,000)含有, キシロカイン注射液「2%」エピレナミン(1:80,000)含有
Nonproprietary names リドカイン塩酸塩・アドレナリン
Companies 製造販売/サンドファーマ株式会社, 販売/サンド株式会社
Product type Prescription drug
Therapeutic category 局所麻酔剤
Therapeutic category codes 871214
YJ codes 1214400A1022, 1214400A2029, 1214400A3025
Approval numbers 13127KUZ01613004, 13127KUZ01613007, 13127KUZ01613003
Package insert edition 第2版
Package insert date Apr 13, 2026
PMDA document key 112268_1214400A1022_4
PMDA company code 112268

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)