PMDA drug package insert

ラパリムス錠1mg

PMDA Prescription drug · ノーベルファーマ株式会社 · package insert Apr 6, 2026

Key facts

Brand names ラパリムス錠1mg, ラパリムス顆粒0.2%
Nonproprietary names シロリムス
Companies 製造販売元/ノーベルファーマ株式会社
Product type Prescription drug
Therapeutic category mTOR阻害剤
Therapeutic category codes 874291
YJ codes 4291035F1023, 4291035D1022
Approval numbers 22600AMX00763000, 30600AMX00009000
Package insert edition 第7版
Package insert date Apr 6, 2026
PMDA document key 620095_4291035F1023_1
PMDA company code 620095

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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:

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