Japan· JP-3959402D2023
アルテプラーゼ（遺伝子組換え）
A medicinal product containing アルテプラーゼ（遺伝子組換え）, registered in Japan by 協和キリン, on the national reimbursement list.
Checked against MHLW / PMDA (Japan) on
Informational only — not a medical device.
The record
At a glance
MHLW / PMDA (Japan)- Active substance
- アルテプラーゼ（遺伝子組換え）
- Manufacturer
- 協和キリン
- Country
- Japan (JP)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- MHLW / PMDA (Japan)
- Last checked
- September 25, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
アルテプラーゼ（遺伝子組換え） in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomActilyse 10mg powder and solvent for solution for injection vialsBoehringer Ingelheim Ltd
- FinlandActilyseParanova Oy
- NetherlandsActilyse 10 mg, poeder en oplosmiddel voor oplossing voor injectie en infusieBoehringer Ingelheim B.V.
- BelgiumActilyse 10 mg/10 mlBoehringer Ingelheim
- SwitzerlandActilyse 10mg, Pulver und Lösungsmittel zur Herstellung einer Injektions-/InfusionslösungBoehringer Ingelheim (Schweiz) GmbH
- IrelandActilyse 10 mg powder and solvent for solution for injection and infusionBoehringer Ingelheim International GmbH
- NorwayActilyseBoehringer lngelheim International GmbH
- CzechiaACTILYSEBoehringer Ingelheim International GmbH, Ingelheim am Rhein
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Actilyse, Actilyse Cathflo
- Belgium · Actilyse, Actilyse Cathflo
- Bulgaria · Актилизе
- Cyprus · Actilyse, Actilyse Cathflo
- Czechia · Actilyse
- Germany · Actilyse, Actilyse Cathflo
- Denmark · Actilyse
- Estonia · Actilyse
- Spain · Actilyse
- Finland · Actilyse
- France · Actilyse
- United Kingdom (Northern Ireland) · Actilyse, Actilyse Cathflo
- Greece · Actilyse, Actilyse Cathflo
- Croatia · Actilyse
- Hungary · Actilyse
- Ireland · Actilyse, Actilyse Cathflo
- Iceland · Actilyse
- Italy · Actilyse
- Lithuania · Actilyse
- Luxembourg · Actilyse, Actilyse Cathflo
- Latvia · Actilyse
- Malta · Actilyse
- Netherlands · Actilyse, Actilyse Cathflo
- Norway · Actilyse
- Poland · Actilyse 10, Actilyse 20
- Portugal · Actilyse, Actilyse Cathflo
- Romania · Actilyse
- Sweden · Actilyse
- Slovenia · Actilyse, Actilyse Cathflo
- Slovakia · Actilyse
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of MHLW / PMDA (Japan). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/3b3f4c8d-b889-4e2d-a2f6-1608db64ea36 GET /v1/drugs/3b3f4c8d-b889-4e2d-a2f6-1608db64ea36?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"spec": "１，２００万国際単位１瓶（溶解液付）",
"marks": null,
"source": "mhlw",
"remarks": null,
"yj_code": "3959402D2023",
"category": "注射薬",
"price_yen": 67269,
"generic_name": "アルテプラーゼ（遺伝子組換え）",
"product_name_jp": null,
"therapeutic_class": "3959",
"transitional_expiry": null
}See everything about アルテプラーゼ（遺伝子組換え）.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.