Nonafact

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Withdrawn

This medicine's authorisation has been withdrawn

human coagulation factor IX
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Nonafact has been withdrawn at the request of the marketing-authorisation holder.

Nonafact : EPAR - Summary for the public

English (EN) (1.17 MB - PDF)

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български (BG) (724.48 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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español (ES) (631.1 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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čeština (CS) (1.28 MB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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dansk (DA) (1.17 MB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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Deutsch (DE) (1.17 MB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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eesti keel (ET) (630.08 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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ελληνικά (EL) (1.32 MB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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français (FR) (632 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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hrvatski (HR) (651.68 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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italiano (IT) (630.99 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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latviešu valoda (LV) (1.26 MB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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lietuvių kalba (LT) (654.33 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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magyar (HU) (697.06 KB - PDF)

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Malti (MT) (705.64 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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Nederlands (NL) (632.18 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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polski (PL) (677.25 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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português (PT) (630.8 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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română (RO) (652.2 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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slovenčina (SK) (702.68 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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slovenščina (SL) (696.3 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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Suomi (FI) (630.29 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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svenska (SV) (631.66 KB - PDF)

First published: 11/09/2006Last updated: 18/02/2020
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Product information

Nonafact : EPAR - Product Information

English (EN) (723.28 KB - PDF)

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български (BG) (1.46 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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español (ES) (701.19 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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čeština (CS) (2.16 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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dansk (DA) (1.28 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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Deutsch (DE) (1.29 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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eesti keel (ET) (756.74 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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ελληνικά (EL) (2.52 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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français (FR) (722.23 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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hrvatski (HR) (917.01 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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italiano (IT) (701 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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latviešu valoda (LV) (1.93 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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lietuvių kalba (LT) (881.32 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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magyar (HU) (1.2 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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Malti (MT) (1.22 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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Nederlands (NL) (740.48 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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polski (PL) (1.26 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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português (PT) (723.26 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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română (RO) (883.77 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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slovenčina (SK) (1.23 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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slovenščina (SL) (1.19 MB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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Suomi (FI) (705.99 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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svenska (SV) (718.96 KB - PDF)

First published: 18/12/2007Last updated: 18/02/2020
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Latest procedure affecting product information: IB/0062
24/11/2016
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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).

Nonafact : EPAR - All Authorised presentations

English (EN) (661.7 KB - PDF)

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български (BG) (678.58 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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español (ES) (658.5 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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čeština (CS) (665.25 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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dansk (DA) (663.15 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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Deutsch (DE) (665.66 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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eesti keel (ET) (625.82 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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ελληνικά (EL) (692.11 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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français (FR) (657.87 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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italiano (IT) (657.42 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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latviešu valoda (LV) (1.2 MB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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lietuvių kalba (LT) (644.52 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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magyar (HU) (643.21 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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Malti (MT) (662.72 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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Nederlands (NL) (660.32 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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polski (PL) (665.83 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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português (PT) (658.44 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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română (RO) (647.42 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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slovenčina (SK) (663.13 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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slovenščina (SL) (649.75 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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Suomi (FI) (658.13 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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svenska (SV) (661 KB - PDF)

First published: 15/11/2005Last updated: 18/02/2020
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Product details

Name of medicine
Nonafact
Active substance
human coagulation factor IX
International non-proprietary name (INN) or common name
human coagulation factor IX
Therapeutic area (MeSH)
Hemophilia B
Anatomical therapeutic chemical (ATC) code
B02BD04

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Authorisation details

EMA product number
EMEA/H/C/000348
Marketing authorisation holder
Sanquin Plasma Products B.V.

Plesmanlaan 125
NL-1066 CX Amsterdam
The Netherlands

Marketing authorisation issued
03/07/2001
Revision
9

Assessment history

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

English (EN) (1.24 MB - PDF)

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

English (EN) (888.66 KB - PDF)

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Nonafact : EPAR - Procedural steps taken before authorisation

English (EN) (961.53 KB - PDF)

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Nonafact : EPAR - Scientific Discussion

English (EN) (831.94 KB - PDF)

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More information on Nonafact

Public statement on Nonafact

Reference Number: EMA/326040/2019

English (EN) (681.78 KB - PDF)

First published:
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