PANTOPRAZOLE Powder for solution for injection Ref.[7033] Active ingredients: Pantoprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2025  Publisher: Amarox Limited, Congress House, 14 Lyon Road, Harrow, HA1 2EN, United Kingdom

Product name and form

Pantoprazole 40 mg powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection.

White to off-white powder.

Qualitative and quantitative composition

Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).

For the full list of excipients, see section 6.1.

Active Ingredient

Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.

List of Excipients

Disodium edetate
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

10 ml clear glass (type I) vial with grey rubber stopper and flip off aluminum seal.

Pack sizes of 1, 5, 10, 20 and 50 glass vials with powder for solution for injection in carton box.

Not all pack sizes may be marketed.

Marketing authorization holder

Amarox Limited, Congress House, 14 Lyon Road, Harrow, HA1 2EN, United Kingdom

Marketing authorization dates and numbers

PL 49445/0070

06/07/2021

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