Padcev
enfortumab vedotin
Table of contents
Overview
Padcev is a cancer medicine for treating adults with urothelial cancer (a cancer of the bladder and urinary tract).
Padcev is for patients whose cancer is advanced or has spread and who have already had platinum- based chemotherapy and an immunotherapy.
It contains the active substance enfortumab vedotin.
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Padcev : EPAR - Medicine overview (PDF/118.64 KB)
First published: 05/05/2022
Last updated: 18/05/2022
EMA/44899/2022 -
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Padcev : EPAR - Risk-management-plan summary (PDF/856.36 KB)
First published: 05/05/2022
Last updated: 08/05/2023
Authorisation details
Product details | |
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Name |
Padcev
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Agency product number |
EMEA/H/C/005392
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Active substance |
Enfortumab vedotin
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International non-proprietary name (INN) or common name |
enfortumab vedotin
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01FX13
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Astellas Pharma Europe B.V.
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
13/04/2022
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Contact address |
Sylviusweg 62 |
Product information
26/04/2023 Padcev - EMEA/H/C/005392 - II/0007
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.