PMDA drug package insert

ゾルゲンスマ点滴静注

PMDA Regenerative medical product · ノバルティスファーマ株式会社 · package insert Nov 26, 2025

Key facts

Brand names ゾルゲンスマ点滴静注
Nonproprietary names オナセムノゲン アベパルボベク
Companies 製造販売元/ノバルティスファーマ株式会社
Product type Regenerative medical product
Package insert date Nov 26, 2025
PMDA document key 300242_4900404X1020_A_01
PMDA company code 300242

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • Yes 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)