OXYNORM Concentrate oral solution Ref.[90500] Active ingredients: Oxycodone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: Mundipharma Pharmaceuticals Ltd, 13, Othellos Street, Dhali Industrial Zone, 2540 Nicosia, Cyprus Tel.: +357 22815656 Fax: +357 22487833 Email: info@mundipharma.com.cy

Product name and form

OxyNorm concentrate 10 mg/ml.

Pharmaceutical Form

OxyNorm concentrate 10mg/ml oral solution is a clear, orange solution.

Qualitative and quantitative composition

Each ml OxyNorm concentrate contains oxycodone base 9 mg as oxycodone hydrochloride 10 mg.

10mg/ml oral solution contains 10mg of oxycodone hydrochloride per 1 ml.

For excipients, see Section 6.1

1 ml oral solution contains 1 mg sodium benzoate (E211) and 0.1 mg sunset yellow FCF (E110).

Active Ingredient Description
Oxycodone

Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opioid receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative.

List of Excipients

Saccharin sodium
Sodium benzoate
Citric acid monohydrate
Sodium citrate
Hydrochloric acid
Sodium hydroxide
Purified water
Sunset yellow (E110)

Pack sizes and marketing

OxyNorm concentrate is supplied in 120 ml amber glass bottles with polyethylene/polypropylene caps. The bottles are packed into cardboard cartons. An oral syringe is also supplied.

Marketing authorization holder

Mundipharma Pharmaceuticals Ltd, 13, Othellos Street, Dhali Industrial Zone, 2540 Nicosia, Cyprus
Tel.: +357 22815656
Fax: +357 22487833
Email: info@mundipharma.com.cy

Marketing authorization dates and numbers

20973

Date of first authorization: 13/6/11
Date of latest renewal: 22/02/2022

Drugs

Drug Countries
OXYNORM Austria, Australia, Brazil, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, South Africa

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