Overview

The marketing authorisation for Ristempa has been withdrawn at the request of the marketing authorisation holder.

Ristempa : EPAR - Summary for the public

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Ristempa : EPAR - Risk-management-plan summary

Product information

Ristempa : EPAR - Product Information

български (BG) (2.31 MB - PDF)
español (ES) (1.41 MB - PDF)
čeština (CS) (2.14 MB - PDF)
dansk (DA) (1.45 MB - PDF)
Deutsch (DE) (1.39 MB - PDF)
eesti keel (ET) (1.29 MB - PDF)
ελληνικά (EL) (2.54 MB - PDF)
français (FR) (1.46 MB - PDF)
hrvatski (HR) (1.43 MB - PDF)
íslenska (IS) (915.98 KB - PDF)
italiano (IT) (1.49 MB - PDF)
latviešu valoda (LV) (2.02 MB - PDF)
lietuvių kalba (LT) (1.57 MB - PDF)
magyar (HU) (2.14 MB - PDF)
Malti (MT) (2.13 MB - PDF)
Nederlands (NL) (1.48 MB - PDF)
norsk (NO) (1.08 MB - PDF)
polski (PL) (2.19 MB - PDF)
português (PT) (1.46 MB - PDF)
română (RO) (1.5 MB - PDF)
slovenčina (SK) (2.77 MB - PDF)
slovenščina (SL) (2.09 MB - PDF)
Suomi (FI) (1.42 MB - PDF)
svenska (SV) (1.48 MB - PDF)

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.
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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
Therapeutic area (MeSH)
Neutropenia
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

Ristempa : EPAR - Public assessment report

CHMP summary of positive opinion for Ristempa

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