Iblias

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Withdrawn

This medicine's authorisation has been withdrawn

octocog alfa
MedicineHumanWithdrawn

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 3 September 2019, the European Commission withdrew the marketing authorisation for Iblias (octocog alfa) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bayer AG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Iblias was granted marketing authorisation in the EU on 18 February 2016 for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2018. 

The European Public Assessment Report (EPAR) for Iblias is updated to indicate that the marketing authorisation is no longer valid.

Iblias : EPAR - Summary for the public

Reference Number: EMEA/H/C/004147

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Malti (MT) (709.33 KB - PDF)

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Nederlands (NL) (634.13 KB - PDF)

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polski (PL) (707.63 KB - PDF)

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suomi (FI) (633.26 KB - PDF)

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svenska (SV) (663.78 KB - PDF)

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Iblias : EPAR - Risk-management-plan summary

Reference Number: EMA/1562/2016

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Product information

Iblias : EPAR - Product Information

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български (BG) (2.24 MB - PDF)

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español (ES) (809.65 KB - PDF)

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čeština (CS) (1.5 MB - PDF)

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dansk (DA) (1.16 MB - PDF)

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eesti (ET) (802.89 KB - PDF)

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ελληνικά (EL) (1.97 MB - PDF)

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français (FR) (1.23 MB - PDF)

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hrvatski (HR) (1.21 MB - PDF)

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latviešu (LV) (1.57 MB - PDF)

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lietuvių (LT) (910.21 KB - PDF)

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magyar (HU) (1.49 MB - PDF)

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Malti (MT) (1.89 MB - PDF)

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Nederlands (NL) (835.73 KB - PDF)

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polski (PL) (1.55 MB - PDF)

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português (PT) (825.77 KB - PDF)

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română (RO) (1.25 MB - PDF)

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slovenčina (SK) (1.61 MB - PDF)

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slovenščina (SL) (1.51 MB - PDF)

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suomi (FI) (815.83 KB - PDF)

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Latest procedure affecting product information:A31/0002
10/11/2017
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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).

Iblias : EPAR - All Authorised presentations

English (EN) (575.64 KB - PDF)

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български (BG) (596.48 KB - PDF)

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español (ES) (575.54 KB - PDF)

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čeština (CS) (601.52 KB - PDF)

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dansk (DA) (574.47 KB - PDF)

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Deutsch (DE) (574.02 KB - PDF)

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eesti (ET) (574.22 KB - PDF)

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ελληνικά (EL) (617.28 KB - PDF)

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français (FR) (574.01 KB - PDF)

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hrvatski (HR) (585.23 KB - PDF)

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italiano (IT) (573.99 KB - PDF)

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latviešu (LV) (604.11 KB - PDF)

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lietuvių (LT) (585.62 KB - PDF)

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magyar (HU) (600.67 KB - PDF)

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Malti (MT) (602.23 KB - PDF)

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Nederlands (NL) (575.64 KB - PDF)

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polski (PL) (602.55 KB - PDF)

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português (PT) (575.48 KB - PDF)

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română (RO) (587.68 KB - PDF)

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slovenčina (SK) (600.53 KB - PDF)

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slovenščina (SL) (589.67 KB - PDF)

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suomi (FI) (574.13 KB - PDF)

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svenska (SV) (574.27 KB - PDF)

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Íslenska (IS) (574.53 KB - PDF)

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norsk (NO) (575.56 KB - PDF)

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Product details

Name of medicine
Iblias
Active substance
octocog alfa
International non-proprietary name (INN) or common name
octocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BD02

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Iblias can be used for all age groups.

Authorisation details

EMA product number
EMEA/H/C/004147
Marketing authorisation holder
Bayer AG

51368 Leverkusen 
Germany

Marketing authorisation issued
18/02/2016
Revision
4

Assessment history

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

English (EN) (643.27 KB - PDF)

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Iblias-H-C-4147-A31-0002 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/763977/2017

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Iblias : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/71742/2016

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CHMP summary of opinion for Iblias

Adopted Reference Number: EMA/CHMP/774757/2015

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