PMDA drug package insert

ヒブトロバック水性懸濁注射用

PMDA Prescription drug · KMバイオロジクス株式会社 · package insert Jul 29, 2026

Key facts

Brand names ヒブトロバック水性懸濁注射用
Nonproprietary names 沈降精製百日せきジフテリア破傷風不活化ポリオヘモフィルスb型混合ワクチン
Companies 製造販売元/KMバイオロジクス株式会社, 販売元/旭化成セラピューティクス株式会社
Product type Prescription drug
Therapeutic category ワクチン・トキソイド混合製剤
Therapeutic category codes 876361
YJ codes 6361400G1023
Approval numbers 30700AMX00248
Package insert edition 第2版
Package insert date Jul 29, 2026
PMDA document key 261976_6361400G1023_1
PMDA company code 261976

At a glance

  • 1–9 Package insert revisions
  • 1–9 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:

Browse all PMDA approved drugs and package inserts (Japan)