PMDA drug package insert

レペタン坐剤0.2mg

PMDA Prescription drug · 大塚製薬株式会社 · package insert Feb 13, 2023

Key facts

Brand names レペタン坐剤0.2mg, レペタン坐剤0.4mg
Nonproprietary names ブプレノルフィン塩酸塩
Companies 製造販売元/大塚製薬株式会社
Product type Prescription drug
Therapeutic category 鎮痛剤
Therapeutic category codes 871149
YJ codes 1149703J1020, 1149703J2027
Approval numbers 20200AMZ00648, 20200AMZ00649
Package insert edition 第1版
Package insert date Feb 13, 2023
PMDA document key 180078_1149703J1020_1
PMDA company code 180078

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)