ETORIAX Film-coated tablet

Product name and form

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.

Qualitative and quantitative composition

Each film-coated tablet contains 90 or 120 mg etoricoxib.

For the full list of excipients, see section 6.1.

List of Excipients

Tablet core:

Cellulose, microcrystalline
Calcium hydrogen phosphate
Croscarmellose sodium
Sodium stearyl fumarate
Silica, colloidal anhydrous

Film coating:

Poly(vinyl alcohol)
Titanium dioxide (E171)
Macrogol 3000
Talc

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).

Pack sizes and marketing

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.

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-Stra├če 5, 27472 Cuxhaven, Germany

Marketing authorization dates and numbers

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

Drugs

Drug
Countries
Germany