Revision Year: 2021 Publisher: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Etoriax 90 mg film-coated tablets.
Etoriax 120 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Etoriax 90 mg film-coated tablets: Pink, round (diameter: 9 mm), biconvex, film coated tablets with beveled edges, engraved with mark “90” on one side of the tablet. Etoriax 120 mg film-coated tablets: Brownish red, round (diameter: 10 mm), slightly biconvex, film coated tablets with beveled edges, scored on one side of the tablet. The score line is not intended for breaking the tablet. |
Each film-coated tablet contains 90 or 120 mg etoricoxib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Etoricoxib |
Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range. Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established. |
| List of Excipients |
|---|
|
Tablet core: Cellulose, microcrystalline Film coating: Poly(vinyl alcohol) Etoriax 60 mg film-coated tablets also contain yellow iron oxide (E172). Etoriax 90 mg film-coated tablets and 120 mg tablets also contain red iron oxide red (E172). |
Etoriax 30 mg film-coated tablets: Blister (OPA/Al/PVC, Alu foil): 28 film-coated tablets, in a box.
Etoriax 60 mg and 90 mg film-coated tablets: Blister (OPA/Al/PVC, Alu foil): 20 and 28 film-coated tablets, in a box.
Etoriax 120 mg film-coated tablets: Blister (OPA/Al/PVC, Alu foil): 5 and 7 film-coated tablets, in a box.
Not all pack sizes may be marketed.
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
MA982/01401 – Etoriax 90 mg film-coated tablets
MA982/01402 – Etoriax 120 mg film-coated tablets
Date of first authorisation: 3rd August 2018
Date of renewal: 1st November 2021
| Drug | Countries | |
|---|---|---|
| ETORIAX | Germany, Malta |
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