PMDA drug package insert

レナリドミドカプセル2.5mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Jul 3, 2026

Key facts

Brand names レナリドミドカプセル2.5mg「サワイ」, レナリドミドカプセル5mg「サワイ」
Nonproprietary names レナリドミド
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 抗造血器悪性腫瘍剤
Therapeutic category codes 874291
YJ codes 4291024M2055, 4291024M1059
Approval numbers 30500AMX00081000, 30500AMX00082000
Package insert edition 第5版
Package insert date Jul 3, 2026
PMDA document key 300119_4291024M1059_1
PMDA company code 300119

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No 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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