Overview

The marketing authorisation for Zenapax has been withdrawn at the request of the marketing authorisation holder.

Zenapax : EPAR - Summary for the public

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svenska (SV) (257.79 KB - PDF)

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Product information

Zenapax : EPAR - Product Information

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български (BG) (650.22 KB - PDF)

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español (ES) (463.91 KB - PDF)

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čeština (CS) (569.39 KB - PDF)

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dansk (DA) (463.7 KB - PDF)

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Deutsch (DE) (479.94 KB - PDF)

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eesti keel (ET) (703.49 KB - PDF)

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ελληνικά (EL) (667.18 KB - PDF)

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français (FR) (478.65 KB - PDF)

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italiano (IT) (471.14 KB - PDF)

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latviešu valoda (LV) (580.43 KB - PDF)

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lietuvių kalba (LT) (529.31 KB - PDF)

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magyar (HU) (532.16 KB - PDF)

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Malti (MT) (556.66 KB - PDF)

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Nederlands (NL) (476.71 KB - PDF)

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polski (PL) (564.21 KB - PDF)

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português (PT) (470.94 KB - PDF)

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română (RO) (529.91 KB - PDF)

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slovenčina (SK) (535.54 KB - PDF)

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slovenščina (SL) (517.13 KB - PDF)

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Suomi (FI) (460.02 KB - PDF)

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svenska (SV) (462.42 KB - PDF)

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Latest procedure affecting product information: IA/0026

23/01/2007

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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).

Zenapax : EPAR - All Authorised presentations

English (EN) (273.05 KB - PDF)

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español (ES) (273.14 KB - PDF)

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dansk (DA) (276.56 KB - PDF)

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Deutsch (DE) (279.34 KB - PDF)

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ελληνικά (EL) (320.27 KB - PDF)

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français (FR) (273.35 KB - PDF)

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italiano (IT) (271.35 KB - PDF)

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Nederlands (NL) (273.34 KB - PDF)

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português (PT) (274.07 KB - PDF)

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Suomi (FI) (271.5 KB - PDF)

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svenska (SV) (274.88 KB - PDF)

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Product details

Name of medicine
Zenapax
Active substance
daclizumab
International non-proprietary name (INN) or common name
daclizumab
Therapeutic area (MeSH)
  • Graft Rejection
  • Kidney Transplantation
Anatomical therapeutic chemical (ATC) code
L04AA08

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.

Authorisation details

EMA product number
EMEA/H/C/000198
Marketing authorisation holder
Roche Registration Ltd.

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Marketing authorisation issued
26/02/1999
Revision
8

Assessment history

Zenapax : EPAR - Procedural steps taken and scientific information after authorisation

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Zenapax : EPAR - Steps taken after authorisation when a cutoff date has been used

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Zenapax : EPAR - Procedural steps taken before authorisation

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Zenapax : EPAR - Scientific Discussion

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More information on Zenapax

Public statement on Zenapax: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMEA/683765/2008

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