STAQUIS Ointment Ref.[28063] Active ingredients: Crisaborole

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

Staquis 20 mg/g ointment.

Pharmaceutical Form

Ointment.

White to off-white ointment.

Qualitative and quantitative composition

One g of ointment contains 20 mg of crisaborole.

Excipients with known effect:

Propylene glycol, 90 mg/g of ointment.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Crisaborole

Crisaborole is an anti-inflammatory benzoxaborole phosphodiesterase-4 (PDE4) inhibitor that suppresses secretion of certain cytokines, such as tumour necrosis factor-α (TNF-α), interleukins (IL-2, IL-4, IL-5), and interferon gamma (IFNγ), and improves skin barrier function as measured by transepidermal water loss (TEWL). It is used for treatment of mild to moderate atopic dermatitis in adults and paediatric patients.

List of Excipients

Paraffin, white soft
Propylene glycol (E1520)
Glycerol monostearate 40-55 (Type I)
Paraffin, hard
Sodium calcium edetate

Pack sizes and marketing

Multi-layered laminate tube with a high density polyethylene tube head with a peel seal, and a white polypropylene cap closure. The exterior layer of the tube consists of seven layers (low-density polyethylene, white high-density polyethylene, high-density polyethylene, low-density polyethylene, ethylene-acrylic acid, foil, and ethylene-acrylic acid). The inner lining consists of linear low-density polyethylene.

Tubes of 2.5 g, 30 g, 60 g, and 100 g. Six tubes per carton for the 2.5 g tubes. One tube per carton for the 30 g, 60 g, and 100 g tubes.

Not all tube sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/19/1421/001
EU/1/19/1421/002
EU/1/19/1421/003
EU/1/19/1421/004

Date of first authorisation: 27 March 2020

Drugs

Drug Countries
STAQUIS Austria, Estonia, Hong Kong, Israel, Lithuania, Poland, South Africa

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