PMDA drug package insert

ヘプタバックス−II水性懸濁注シリンジ0.25mL

PMDA Prescription drug · MSD株式会社 · package insert Oct 1, 2020

Key facts

Brand names ヘプタバックス−II水性懸濁注シリンジ0.25mL, ヘプタバックス−II水性懸濁注シリンジ0.5mL
Nonproprietary names 組換え沈降B型肝炎ワクチン
Companies 製造販売元/MSD株式会社
Product type Prescription drug
Therapeutic category ウイルスワクチン類
Therapeutic category codes 876313
YJ codes 6313402G1025, 6313402G2021
Approval numbers 22900AMX00996000, 22900AMX00997000
Package insert edition 第1版
Package insert date Oct 1, 2020
PMDA document key 170050_6313402G1025_1
PMDA company code 170050

At a glance

  • 1–9 Package insert revisions
  • 10–99 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)