Erdafitinib

Balversa 3 MG Comprimidos Recubiertos con Pelicula

3 mg comprimido recubierto con películaSpainMarketedAuthorised 27 Aug 2024

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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.

BalversaEuropean UnionAuthorised

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Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Erdafitinib

Balversa 3 MG Comprimidos Recubiertos con Pelicula

3 mg comprimido recubierto con películaSpainMarketedAuthorised 27 Aug 2024

Product informationAsk Osler about it

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.

BalversaEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Balversa 3 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NV

Balversa 4 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NV

Balversa 5 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NV

BalversaSaudi Arabia · Janssen-Cilag SPA

Balversa Film-Coated Tablets 3MGSingapore · 3.00 mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTD

Balversa Film-Coated Tablets 4MGSingapore · 4.00 mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTD

Balversa Film-Coated Tablets 5MGSingapore · 5.00 mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTD

Balversa film-coated tablets 3mgTaiwan · 膜衣錠 · 嬌生股份有限公司

Balversa film-coated tablets 4mgTaiwan · 膜衣錠 · 嬌生股份有限公司

Balversa film-coated tablets 5mgTaiwan · 膜衣錠 · 嬌生股份有限公司

BalversaUnited States · 3MG, 4MG, 5MG · tablet · Janssen Biotech

ErdafitinibUnited States · tablet · Natco Pharma LTD

ErfandelBrazil · Janssen-Cilag Farmacêutica Ltda

Packs

Pack	Code	Status
BALVERSA 3 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 84 comprimidos	765641

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.

Agencia Española de Medicamentos y Productos Sanitarios

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: Erdafitinib
Strength: 3 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 27 Aug 2024
Registration: 1241841004
Marketing authorisation holder: Janssen-Cilag International N.V
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/24/1841

Spain