Epcoritamab

Tepkinly 4 MG/0,8 ML Solucion Inyectable

5 mg/ml concentrado para solución inyectableSpainMarketedAuthorised 4 Oct 2023

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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.

TepkinlyEuropean UnionAuthorised

TepkinlyEuropean Union · AbbVie Deutschland GmbH & Co. KGSame brand
TepkinlyCroatiaSame brand
TepkinlyItaly · Concentrato per soluzione iniettabile · Abbvie Deutschland GMBH & Co. KGSame brand
Tepkinly 4 mg/0,8 oplossing voor injectieNetherlands · Oplossing voor injectie · AbbVie Deutschland GmbH & Co. KGSame brand
Tepkinly 48 mg oplossing voor injectieNetherlands · Oplossing voor injectie · AbbVie Deutschland GmbH & Co. KGSame brand

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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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Epcoritamab

Tepkinly 4 MG/0,8 ML Solucion Inyectable

5 mg/ml concentrado para solución inyectableSpainMarketedAuthorised 4 Oct 2023

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.

TepkinlyEuropean 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

Epkinly Solution for Injection 48MG/0.8MLSingapore · 48mg/0.8mL · injection, solution · Abbvie Pte. LTD.

Epkinly Solution for Injection 4MG/0.8MLSingapore · 4.0mg/0.8mL · injection, solution, concentrate · Abbvie Pte. LTD.

EpkinlyUnited States · 48MG/0.8ML, 4MG/0.8ML · injectable · Genmab US, INC.

EpkinlyBrazil · Abbvie Farmacêutica Ltda.

EpkinlyCanada · 60 MG / ML · Solution · Abbvie Corporation

EpkinlyCanada · 5 MG / ML · Solution · Abbvie Corporation

Packs

Pack	Code	Status
TEPKINLY 4 MG/0,8 ML SOLUCION INYECTABLE, 1 vial de 0,8 ml	763372

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: Epcoritamab
Strength: 5 mg/ml
Dosage form: concentrado para solución inyectable
Route: vía subcutánea
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 4 Oct 2023
Registration: 1231759001
Marketing authorisation holder: Abbvie Deutschland Gmbh & Co. Kg
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/23/1759