PMDA drug package insert

0.5%カルボカイン注

PMDA Prescription drug · サンドファーマ株式会社 · package insert Jul 31, 2023

Key facts

Brand names 0.5%カルボカイン注, 1%カルボカイン注, 2%カルボカイン注
Nonproprietary names メピバカイン塩酸塩
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 1214402A1021, 1214402A2028, 1214402A3024
Approval numbers 20700AMY10001000, 20700AMY10002000, 20700AMY10003000
Package insert edition 第1版
Package insert date Jul 31, 2023
PMDA document key 112268_1214402A1021_2
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)