Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Organon Pharma (UK) Limited, The Hewett Building, 14 Hewett Street, London EC2A 3NP, United Kingdom
ARCOXIA 30 mg film-coated tablets.
ARCOXIA 60 mg film-coated tablets.
ARCOXIA 90 mg film-coated tablets.
ARCOXIA 120 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablets (tablets). 30 mg tablets: Blue-green, apple-shaped biconvex tablets debossed ‘101’ on one side and ‘ACX 30’ on the other side. 60 mg tablets: Dark green, apple-shaped, biconvex tablets debossed ‘200’ on one side and ‘ARCOXIA 60’ on the other side. 90 mg tablets: White, apple-shaped, biconvex tablets debossed ‘202’ on one side and ‘ARCOXIA 90’ on the other side. 120 mg tablets: Pale-green, apple-shaped, biconvex tablets debossed ‘204’ on one side and ‘ARCOXIA 120’ on the other side. |
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Excipient(s) with known effect:
30 mg tablet: 1.3 mg lactose (as monohydrate).
60 mg tablet: 2.7 mg lactose (as monohydrate).
90 mg tablet: 4.0 mg lactose (as monohydrate).
120 mg tablet: 5.3 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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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 |
|---|
|
Core: Calcium hydrogen phosphate (anhydrous) Tablet coating: Carnauba wax The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172). |
30 mg: Aluminium/aluminium blisters in packs containing 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets.
60 mg: Aluminium/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets.
90 and 120 mg: Aluminium/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets.
60, 90 and 120 mg: Aluminium/aluminium blisters (unit doses) in packs of 5, 50 or 100 tablets.
White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two 1-gram desiccant containers or 90 tablets and one 1-gram desiccant container.
Not all pack sizes may be marketed.
Organon Pharma (UK) Limited, The Hewett Building, 14 Hewett Street, London EC2A 3NP, United Kingdom
30 mg Tablets PL 00025/0641
60 mg Tablets PL 00025/0642
90 mg Tablets PL 00025/0643
120 mg Tablets PL 00025/0644
Date of latest renewal: 30 mg Tablets 22/10/2007
Date of latest renewal: 60 mg Tablets 13/02/2002
Date of latest renewal: 90 mg Tablets 13/02/2002
Date of latest renewal: 120 mg Tablets 13/02/2002
| Drug | Countries | |
|---|---|---|
| ARCOXIA | Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, South Africa |
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