Ristempa

RSS
Withdrawn

This medicine's authorisation has been withdrawn

pegfilgrastim
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Ristempa has been withdrawn at the request of the marketing authorisation holder.

Ristempa : EPAR - Summary for the public

English (EN) (1.39 MB - PDF)

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български (BG) (596.74 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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español (ES) (518.95 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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čeština (CS) (573.94 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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dansk (DA) (518.15 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Deutsch (DE) (514.2 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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eesti keel (ET) (517.48 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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ελληνικά (EL) (600.7 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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français (FR) (513.57 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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hrvatski (HR) (534.56 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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italiano (IT) (517.19 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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latviešu valoda (LV) (573.72 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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lietuvių kalba (LT) (535.48 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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magyar (HU) (570.33 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Malti (MT) (575.73 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Nederlands (NL) (518.16 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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polski (PL) (574.3 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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português (PT) (517.7 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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română (RO) (534.55 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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slovenčina (SK) (1.02 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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slovenščina (SL) (568.91 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Suomi (FI) (512.8 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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svenska (SV) (512.44 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Ristempa : EPAR - Risk-management-plan summary

English (EN) (1.4 MB - PDF)

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Product information

Ristempa : EPAR - Product Information

English (EN) (2.56 MB - PDF)

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български (BG) (2.31 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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español (ES) (1.41 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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čeština (CS) (2.14 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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dansk (DA) (1.45 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Deutsch (DE) (1.39 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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eesti keel (ET) (1.29 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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ελληνικά (EL) (2.54 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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français (FR) (1.46 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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hrvatski (HR) (1.43 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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íslenska (IS) (915.98 KB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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italiano (IT) (1.49 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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latviešu valoda (LV) (2.02 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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lietuvių kalba (LT) (1.57 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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magyar (HU) (2.14 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Malti (MT) (2.13 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Nederlands (NL) (1.48 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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norsk (NO) (1.08 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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polski (PL) (2.19 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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português (PT) (1.46 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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română (RO) (1.5 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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slovenčina (SK) (2.77 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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slovenščina (SL) (2.09 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Suomi (FI) (1.42 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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svenska (SV) (1.48 MB - PDF)

First published: 16/04/2015Last updated: 07/03/2018
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Latest procedure affecting product information: IAIN/0010
29/09/2017
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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).

Product details

Name of medicine
Ristempa
Active substance
pegfilgrastim
International non-proprietary name (INN) or common name
pegfilgrastim
Anatomical therapeutic chemical (ATC) code
L03AA13

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

Authorisation details

EMA product number
EMEA/H/C/003910
Marketing authorisation holder
Amgen Europe B.V.

Minervum 7061
4817 ZK Breda
The Netherlands

Opinion adopted
26/02/2015
Marketing authorisation issued
13/04/2015
Revision
3

Assessment history

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

English (EN) (1.4 MB - PDF)

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Ristempa : EPAR - Public assessment report

AdoptedReference Number: EMA/187414/2015

English (EN) (1.7 MB - PDF)

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CHMP summary of positive opinion for Ristempa

AdoptedReference Number: EMA/CHMP/83846/2015

English (EN) (506.13 KB - PDF)

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More information on Ristempa

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

Reference Number: EMA/792923/2017

English (EN) (59.23 KB - PDF)

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