PMDA drug package insert

モニラック・シロップ65%

PMDA Prescription drug · 丸石製薬株式会社 · package insert Dec 1, 2025

Key facts

Brand names モニラック・シロップ65%
Nonproprietary names ラクツロース
Companies 製造販売元/丸石製薬株式会社
Product type Prescription drug
Therapeutic category 生理的腸管機能改善・高アンモニア血症用剤
Therapeutic category codes 872359, 873999
YJ codes 3999001Q2058
Approval numbers 21700AMX00142
Package insert edition 第3版
Package insert date Dec 1, 2025
PMDA document key 730119_3999001Q2058_2
PMDA company code 730119

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)