TruScient

RSS
Withdrawn

This medicine's authorisation has been withdrawn

dibotermin alfa
MedicineVeterinaryWithdrawn
  • Application under evaluation
  • CVMP opinion
  • European Commission decision

Overview

The marketing authorisation for TruScient has been withdrawn at the request of the marketing authorisation holder.

TruScient : EPAR - Summary for the public

Reference Number: EMA/848040/2011

English (EN) (197.48 KB - PDF)

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български (BG) (218.13 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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español (ES) (219.39 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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čeština (CS) (221.21 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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dansk (DA) (196.28 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Deutsch (DE) (219.87 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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eesti keel (ET) (220.58 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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ελληνικά (EL) (223.98 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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français (FR) (220.78 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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italiano (IT) (218.46 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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latviešu valoda (LV) (216.78 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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lietuvių kalba (LT) (218.76 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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magyar (HU) (239.21 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Malti (MT) (219.92 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Nederlands (NL) (195.35 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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polski (PL) (222.4 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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português (PT) (196.44 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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română (RO) (219.8 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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slovenčina (SK) (242.89 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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slovenščina (SL) (233.64 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Suomi (FI) (195.98 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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svenska (SV) (193.82 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Product information

TruScient : EPAR - Product Information

English (EN) (391.93 KB - PDF)

First published: Last updated:
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български (BG) (443.35 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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español (ES) (365.02 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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čeština (CS) (425.46 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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dansk (DA) (371.48 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Deutsch (DE) (397.22 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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eesti keel (ET) (417.19 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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ελληνικά (EL) (464.42 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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français (FR) (425.36 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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íslenska (IS) (381.08 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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italiano (IT) (399.85 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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latviešu valoda (LV) (426.83 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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lietuvių kalba (LT) (428.56 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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magyar (HU) (436.37 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Malti (MT) (483.67 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Nederlands (NL) (410.73 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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norsk (NO) (390.32 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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polski (PL) (443.92 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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português (PT) (374.05 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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română (RO) (427.72 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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slovenčina (SK) (431.78 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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slovenščina (SL) (430.91 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Suomi (FI) (391.15 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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svenska (SV) (396.36 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Latest procedure affecting product information:IAIN/0005/G
15/01/2015

TruScient : EPAR - All Authorised presentations

English (EN) (387.57 KB - PDF)

First published: Last updated:
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български (BG) (410.19 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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español (ES) (394.1 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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čeština (CS) (404.3 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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dansk (DA) (393.94 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Deutsch (DE) (387.42 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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eesti keel (ET) (387.03 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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ελληνικά (EL) (407.02 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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français (FR) (386.86 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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íslenska (IS) (259.1 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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italiano (IT) (259.23 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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latviešu valoda (LV) (276.1 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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lietuvių kalba (LT) (267.12 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
View

magyar (HU) (272.45 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Malti (MT) (275.42 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Nederlands (NL) (259.53 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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norsk (NO) (263.99 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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polski (PL) (275.32 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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português (PT) (259.68 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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română (RO) (271.55 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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slovenčina (SK) (275.09 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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slovenščina (SL) (265.89 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Suomi (FI) (393.53 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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svenska (SV) (263.95 KB - PDF)

First published: 20/12/2011 Last updated: 03/02/2015
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Product details

Name of medicine
TruScient
Active substance
dibotermin alfa
International non-proprietary name (INN) or common name
dibotermin alfa
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) code
QM05BC01

Pharmacotherapeutic group

Bone morphogenetic proteins

Therapeutic indication

Osteoinductive agent for use in the treatment of long-bone fractures as an adjunct to standard surgical care using open fracture reduction in dogs.

Authorisation details

EMA product number
EMEA/V/C/002000
Marketing authorisation holder
Zoetis Belgium SA

Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Marketing authorisation issued
14/12/2011
Revision
4

Assessment history

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

English (EN) (334.08 KB - PDF)

First published: Last updated:
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TruScient : EPAR - Public assessment report

Adopted Reference Number: EMA/847913/2011

English (EN) (422.03 KB - PDF)

First published: Last updated:
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CVMP summary of positive opinion for TruScient

Adopted Reference Number: EMA/CVMP/648569/2011

English (EN) (197.81 KB - PDF)

First published: Last updated:
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