Raplixa

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Withdrawn

This medicine's authorisation has been withdrawn

human fibrinogen / human thrombin
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 19 March 2018, the European Commission withdrew the marketing authorisation of Raplixa (human fibrinogen / human thrombin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mallinckrodt Pharmaceuticals Ireland Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Raplixa was granted marketing authorisation in the EU on 19 March 2015 as supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Raplixa is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Raplixa : EPAR - Summary for the public

Reference Number: EMA/55672/2015

English (EN) (546.23 KB - PDF)

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Raplixa : EPAR - Risk-management-plan summary

English (EN) (571.38 KB - PDF)

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Product information

Raplixa : EPAR - Product Information

English (EN) (846.12 KB - PDF)

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български (BG) (1.37 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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español (ES) (802.94 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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čeština (CS) (1.11 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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dansk (DA) (667.49 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Deutsch (DE) (874.95 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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eesti keel (ET) (792.45 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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ελληνικά (EL) (1.57 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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français (FR) (907.5 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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hrvatski (HR) (816.84 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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íslenska (IS) (769.69 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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italiano (IT) (811.21 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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latviešu valoda (LV) (1.12 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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lietuvių kalba (LT) (903.17 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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magyar (HU) (1.1 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Malti (MT) (1.21 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Nederlands (NL) (752.15 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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norsk (NO) (739.34 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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polski (PL) (1.17 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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português (PT) (675.6 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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română (RO) (854.03 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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slovenčina (SK) (1.16 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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slovenščina (SL) (1.09 MB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Suomi (FI) (743.95 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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svenska (SV) (786.13 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Latest procedure affecting product information: IB/0021/G
19/03/2018
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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).

Raplixa : EPAR - All Authorised presentations

English (EN) (467.44 KB - PDF)

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български (BG) (495.82 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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español (ES) (458.22 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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čeština (CS) (486.16 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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dansk (DA) (473.24 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Deutsch (DE) (486.73 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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eesti keel (ET) (457.96 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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ελληνικά (EL) (522.16 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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français (FR) (458.01 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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hrvatski (HR) (480.96 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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íslenska (IS) (484.51 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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italiano (IT) (485.25 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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latviešu valoda (LV) (489.37 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
View

lietuvių kalba (LT) (473.19 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
View

magyar (HU) (476.56 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Malti (MT) (509.39 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Nederlands (NL) (458.08 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
View

norsk (NO) (457.37 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
View

polski (PL) (485.34 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
View

português (PT) (901.52 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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română (RO) (48.88 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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slovenčina (SK) (478.28 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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slovenščina (SL) (476.99 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Suomi (FI) (457.79 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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svenska (SV) (21.78 KB - PDF)

First published: 04/05/2015Last updated: 10/10/2018
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Product details

Name of medicine
Raplixa
Active substance
  • human fibrinogen
  • human thrombin
International non-proprietary name (INN) or common name
  • human fibrinogen
  • human thrombin
Therapeutic area (MeSH)
Hemostasis, Surgical
Anatomical therapeutic chemical (ATC) code
B02BC30

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.

Raplixa must be used in combination with an approved gelatin sponge.

Raplixa is indicated in adults over 18 years of age.

Authorisation details

EMA product number
EMEA/H/C/002807
Marketing authorisation holder
Mallinckrodt Pharmaceuticals Ireland Limited

College Business Technology Park
Cruiserath
Blanchardstown
Dublin 15
Ireland

Marketing authorisation issued
19/03/2015
Withdrawal of marketing authorisation
19/03/2018
Revision
6

Assessment history

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

English (EN) (586.53 KB - PDF)

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Raplixa : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/747327/2014

English (EN) (3.13 MB - PDF)

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CHMP summary of positive opinion for Raplixa

AdoptedReference Number: EMA/CHMP/197/2015

English (EN) (527.74 KB - PDF)

First published: Last updated:
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