- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Onsior : EPAR - Medicine overview
English (EN) (81.94 KB - PDF)
български (BG) (93.36 KB - PDF)
español (ES) (81.97 KB - PDF)
čeština (CS) (93.99 KB - PDF)
dansk (DA) (83.34 KB - PDF)
Deutsch (DE) (82.76 KB - PDF)
eesti keel (ET) (82.18 KB - PDF)
ελληνικά (EL) (93.76 KB - PDF)
français (FR) (82.44 KB - PDF)
hrvatski (HR) (92.27 KB - PDF)
íslenska (IS) (83.29 KB - PDF)
Gaeilge (GA) (83.57 KB - PDF)
italiano (IT) (82.29 KB - PDF)
latviešu valoda (LV) (94.29 KB - PDF)
lietuvių kalba (LT) (94.03 KB - PDF)
magyar (HU) (94.15 KB - PDF)
Malti (MT) (95.95 KB - PDF)
Nederlands (NL) (82.05 KB - PDF)
norsk (NO) (82 KB - PDF)
polski (PL) (95.62 KB - PDF)
português (PT) (83.01 KB - PDF)
română (RO) (94.17 KB - PDF)
slovenčina (SK) (94.08 KB - PDF)
slovenščina (SL) (82.27 KB - PDF)
Suomi (FI) (81.54 KB - PDF)
svenska (SV) (82.05 KB - PDF)
Product information
Onsior : EPAR - Product Information
English (EN) (81.49 KB - PDF)
български (BG) (91.78 KB - PDF)
español (ES) (81.51 KB - PDF)
čeština (CS) (92.48 KB - PDF)
dansk (DA) (82.05 KB - PDF)
Deutsch (DE) (81.72 KB - PDF)
eesti keel (ET) (81.22 KB - PDF)
ελληνικά (EL) (91.79 KB - PDF)
français (FR) (81.63 KB - PDF)
hrvatski (HR) (91.56 KB - PDF)
íslenska (IS) (81.52 KB - PDF)
Gaeilge (GA) (81.36 KB - PDF)
italiano (IT) (81.76 KB - PDF)
latviešu valoda (LV) (92.14 KB - PDF)
lietuvių kalba (LT) (92.19 KB - PDF)
magyar (HU) (92.76 KB - PDF)
Malti (MT) (93.86 KB - PDF)
Nederlands (NL) (81.15 KB - PDF)
norsk (NO) (81.52 KB - PDF)
polski (PL) (93.22 KB - PDF)
português (PT) (82.53 KB - PDF)
română (RO) (91.73 KB - PDF)
slovenčina (SK) (81.75 KB - PDF)
slovenščina (SL) (81.76 KB - PDF)
Suomi (FI) (81.11 KB - PDF)
svenska (SV) (81.47 KB - PDF)
Onsior : EPAR - All Authorised presentations
English (EN) (81.94 KB - PDF)
български (BG) (93.36 KB - PDF)
español (ES) (81.97 KB - PDF)
čeština (CS) (93.99 KB - PDF)
dansk (DA) (83.34 KB - PDF)
Deutsch (DE) (82.76 KB - PDF)
eesti keel (ET) (82.18 KB - PDF)
ελληνικά (EL) (93.76 KB - PDF)
français (FR) (82.44 KB - PDF)
hrvatski (HR) (92.27 KB - PDF)
íslenska (IS) (83.29 KB - PDF)
Gaeilge (GA) (83.57 KB - PDF)
italiano (IT) (82.29 KB - PDF)
latviešu valoda (LV) (94.29 KB - PDF)
lietuvių kalba (LT) (94.03 KB - PDF)
magyar (HU) (94.15 KB - PDF)
Malti (MT) (95.95 KB - PDF)
Nederlands (NL) (82.05 KB - PDF)
norsk (NO) (82 KB - PDF)
polski (PL) (95.62 KB - PDF)
português (PT) (83.01 KB - PDF)
română (RO) (94.17 KB - PDF)
slovenčina (SK) (94.08 KB - PDF)
slovenščina (SL) (82.27 KB - PDF)
Suomi (FI) (81.54 KB - PDF)
svenska (SV) (82.05 KB - PDF)
Product details
- Name of medicine
- Onsior
- Active substance
- robenacoxib
- International non-proprietary name (INN) or common name
- robenacoxib
Pharmacotherapeutic group
- Anti-inflammatory and anti-rheumatic products, non-steroids
- Coxibs
Authorisation details
- EMA product number
- EMEA/V/C/000127
Assessment history
Onsior : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (81.94 KB - PDF)
Onsior-V-C-127-II-0024-G : EPAR - Assessment Report - Variation
English (EN) (81.49 KB - PDF)
CVMP post-authorisation summary of positive opinion for Onsior (II-0024-G)
English (EN) (123.83 KB - PDF)
Onsior-V-C-127-II-0018-G : EPAR - Assessment Report - Variation
English (EN) (81.49 KB - PDF)
CVMP post-authorisation summary of positive opinion for Onsior
English (EN) (73.63 KB - PDF)
CVMP post-authorisation summary of positive opinion for Onsior
English (EN) (54.28 KB - PDF)
CVMP post-authorisation summary of positive opinion for Onsior
English (EN) (44.16 KB - PDF)
Onsior : EPAR - Scientific Discussion
English (EN) (81.49 KB - PDF)
Onsior : EPAR - Procedural steps taken before authorisation
English (EN) (20.57 KB - PDF)
Committee for medicinal products for veterinary use summary of opinion: Onisor: International Non-proprietary Name (INN): Robenacoxib
English (EN) (25.23 KB - PDF)