In other countries
The same active substances on other registers, the same brand first.
Authorised centrally in the EU
This national listing belongs to a medicine the European Commission authorised for the whole EU.
- LazcluzeBrazil · Janssen-Cilag Farmacêutica LtdaSame brand
- LazcluzeCanada · 240 MG · Tablet · Janssen INCSame brand
- LazcluzeCanada · 80 MG · Tablet · Janssen INCSame brand
- LazcluzeEuropean Union · Janssen Cilag International NVSame brand
- LazcluzeCroatiaSame brand
- LazcluzeItaly · Compressa rivestita con film · Janssen-Cilag International N.V.Same brand
- Lazcluze 240 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand
- Lazcluze 80 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand
- Lazcluze Film-coated Tablets 240mgSingapore · 240 mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame brand
- Lazcluze Film-coated Tablets 80mgSingapore · 80 mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame brand
- Lazcluze film-coated tablets 240 mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand
- Lazcluze film-coated tablets 80 mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand
- LazcluzeUnited States · 240MG BASE, 80MG BASE · tablet · Janssen BiotechSame brand
Packs
| Pack | Code | Status |
|---|---|---|
| LAZCLUZE 80 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 56 comprimidos | 766762 |
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.
Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Lazertinib
- Strength
- 80 mg
- Dosage form
- comprimido recubierto con película
- Route
- vía oral
- Register
- Spain (AEMPS)
- Status
- Marketed
- Status in the register
- Autorizado, comercializado
- Authorised
- 29 Jan 2025
- Registration
- 1241886001
- Marketing authorisation holder
- Janssen-Cilag International N.V
- Procedure
- EU centralised
- Supply
- Diagnóstico Hospitalario
- EU number
- EU/1/24/1886