CELEBREX Capsule, hard

Active ingredients: Celecoxib

Product name and form

Celebrex 100 mg capsules, hard.

Pharmaceutical Form

Capsule, hard.

Opaque, white with two blue bands marked 7767 and 100.

Qualitative and quantitative composition

Each capsule contains 100 mg celecoxib.

Excipient with known effect: Lactose (each capsule contains 149.7 mg lactose monohydrate; see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient

Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily). No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in this dose range in healthy volunteers.

List of Excipients

Capsules content:

Lactose monohydrate
Sodium laurilsulfate
Croscarmellose sodium
Magnesium stearate

Capsule shells:

Titanium dioxide E171
Sodium laurilsulfate
Sorbitan monolaurate

Printing ink:

Indigotine E132
Propylene glycol

Pack sizes and marketing

Clear or opaque PVC/aluminium blisters. Pack of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose, 5x(10x10).

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/1275



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