- 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The marketing authorisation for TruScient has been withdrawn at the request of the marketing authorisation holder.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
English (EN) (197.48 KB - PDF)
български (BG) (218.13 KB - PDF)
español (ES) (219.39 KB - PDF)
čeština (CS) (221.21 KB - PDF)
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français (FR) (220.78 KB - PDF)
italiano (IT) (218.46 KB - PDF)
latviešu valoda (LV) (216.78 KB - PDF)
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magyar (HU) (239.21 KB - PDF)
Malti (MT) (219.92 KB - PDF)
Nederlands (NL) (195.35 KB - PDF)
polski (PL) (222.4 KB - PDF)
português (PT) (196.44 KB - PDF)
română (RO) (219.8 KB - PDF)
slovenčina (SK) (242.89 KB - PDF)
slovenščina (SL) (233.64 KB - PDF)
Suomi (FI) (195.98 KB - PDF)
svenska (SV) (193.82 KB - PDF)
Product information
TruScient : EPAR - Product Information
English (EN) (391.93 KB - PDF)
български (BG) (443.35 KB - PDF)
español (ES) (365.02 KB - PDF)
čeština (CS) (425.46 KB - PDF)
dansk (DA) (371.48 KB - PDF)
Deutsch (DE) (397.22 KB - PDF)
eesti keel (ET) (417.19 KB - PDF)
ελληνικά (EL) (464.42 KB - PDF)
français (FR) (425.36 KB - PDF)
íslenska (IS) (381.08 KB - PDF)
italiano (IT) (399.85 KB - PDF)
latviešu valoda (LV) (426.83 KB - PDF)
lietuvių kalba (LT) (428.56 KB - PDF)
magyar (HU) (436.37 KB - PDF)
Malti (MT) (483.67 KB - PDF)
Nederlands (NL) (410.73 KB - PDF)
norsk (NO) (390.32 KB - PDF)
polski (PL) (443.92 KB - PDF)
português (PT) (374.05 KB - PDF)
română (RO) (427.72 KB - PDF)
slovenčina (SK) (431.78 KB - PDF)
slovenščina (SL) (430.91 KB - PDF)
Suomi (FI) (391.15 KB - PDF)
svenska (SV) (396.36 KB - PDF)
TruScient : EPAR - All Authorised presentations
English (EN) (387.57 KB - PDF)
български (BG) (410.19 KB - PDF)
español (ES) (394.1 KB - PDF)
čeština (CS) (404.3 KB - PDF)
dansk (DA) (393.94 KB - PDF)
Deutsch (DE) (387.42 KB - PDF)
eesti keel (ET) (387.03 KB - PDF)
ελληνικά (EL) (407.02 KB - PDF)
français (FR) (386.86 KB - PDF)
íslenska (IS) (259.1 KB - PDF)
italiano (IT) (259.23 KB - PDF)
latviešu valoda (LV) (276.1 KB - PDF)
lietuvių kalba (LT) (267.12 KB - PDF)
magyar (HU) (272.45 KB - PDF)
Malti (MT) (275.42 KB - PDF)
Nederlands (NL) (259.53 KB - PDF)
norsk (NO) (263.99 KB - PDF)
polski (PL) (275.32 KB - PDF)
português (PT) (259.68 KB - PDF)
română (RO) (271.55 KB - PDF)
slovenčina (SK) (275.09 KB - PDF)
slovenščina (SL) (265.89 KB - PDF)
Suomi (FI) (393.53 KB - PDF)
svenska (SV) (263.95 KB - PDF)
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 proteinsTherapeutic 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)
TruScient : EPAR - Public assessment report
English (EN) (422.03 KB - PDF)
CVMP summary of positive opinion for TruScient
English (EN) (197.81 KB - PDF)