DISLEP Solution for injection / infusion Ref.[51152] Active ingredients: Levosulpiride

Source: Medicines Authority (MT) Revision Year: 2022 Publisher: Ferrer Internacional, S.A., Gran Via Carlos III, 94 Barcelona, 08028, Spain

Product name and form

Dislep 25mg solution for injection/infusion.

Pharmaceutical Form
Clear colourless solution, without foreign body. Solution for injection/infusion.

Qualitative and quantitative composition

One 2 ml ampoule contains:

Active substance: levosulpiride 25 mg.

Excipients with known effects: sodium.

For full list of excipients, see section 6.1.

Active Ingredient	Description
Levosulpiride	Levosulpiride is a selective antagonist at dopamine (D) receptors. Levosulpiride exerts a regulation action both on the central and peripheral nervous circuits controlling the dynamics of digestive system.

List of Excipients
2 N sulfuric acid Water for injections Sodium chloride

Pack sizes and marketing

Carton containing 6 glass ampoules of 25 mg/2 ml.

Marketing authorization holder

Ferrer Internacional, S.A., Gran Via Carlos III, 94 Barcelona, 08028, Spain

Marketing authorization dates and numbers

MA130/00501

10^th November 2021

Drugs

Drug	Countries
DISLEP	Ecuador, Malta, Mexico

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