OZALIN Oral solution Ref.[7755] Active ingredients: Midazolam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: PRIMEX PHARMACEUTICALS OY, Mariankatu 21 C, 00170 Helsinki, Finland

Product name and form

OZALIN 2 mg/ml oral solution in single-dose container.

Pharmaceutical Form

Oral solution in single-dose container.

Clear to slightly opalescent solution, pale yellow to slightly brown, with a pH between 3.6 and 4.2.

Qualitative and quantitative composition

Each ml of OZALIN contains 2 mg of midazolam.

Each 5 ml ampoule of OZALIN contains 10 mg of midazolam.

Excipients with known effects: ethanol (less than 100 mg per ampoule), sodium (less than 1 mmol (23 mg) per ampoule), cyclodextrin (400 mg per ampoule and less than the permitted daily exposure of 20 mg/kg/day at the recommended dose).

For the full list of excipients, see Section 6.1.

Active Ingredient Description

Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of midazolam to form water-soluble salts with acids.

List of Excipients

Citric acid monohydrate
Orange flavour (contains notably 70-80% ethanol)
Sodium hydroxide (for pH-adjustment)
Water for injection

Pack sizes and marketing

5 ml amber glass ampoule (type I glass), one filter straw and one oral applicator packaged together into an individual blister.

Box of 1 ampoule, 1 filter straw and 1 oral applicator.

Box of 5 ampoules, 5 filter straws and 5 oral applicators.

Box of 10 ampoules, 10 filter straws and 10 oral applicators.

Oral applicator and filter straw are for single-use. Oral applicator is presented with graduations in kg of bodyweight: from 3 kg to 40 kg, with increments in one kg.

Not all pack sizes may be marketed.

Marketing authorization holder

PRIMEX PHARMACEUTICALS OY, Mariankatu 21 C, 00170 Helsinki, Finland

Marketing authorization dates and numbers


Date of first authorisation: 24th April 2020


Drug Countries
OZALIN Finland, France, Ireland, United Kingdom

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