PMDA drug package insert

カルボカインアンプル注0.5%

PMDA Prescription drug · 日新製薬株式会社 · package insert Jan 17, 2024

Key facts

Brand names カルボカインアンプル注0.5%, カルボカインアンプル注1%, カルボカインアンプル注2%
Nonproprietary names メピバカイン塩酸塩
Companies 製造販売元/日新製薬株式会社, 販売元/サンド株式会社
Product type Prescription drug
Therapeutic category 局所麻酔剤
Therapeutic category codes 871214
YJ codes 1214402A5043, 1214402A6040, 1214402A8042, 1214402A9049, 1214402H1046, 1214402H3049, 1214402H4045, 1214402H5041
Approval numbers 21800AMX10097, 21800AMX10098, 21800AMX10099
Package insert edition 第1版
Package insert date Jan 17, 2024
PMDA document key 530113_1214402A5043_1
PMDA company code 530113

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)