PALMEUX Prolonged-release suspension for injection Ref.[50171] Active ingredients: Paliperidone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

Product name and form

Palmeux 25 mg prolonged-release suspension for injection in pre-filled syringe.

Pharmaceutical Form

Prolonged-release suspension for injection in pre-filled syringe.

The suspension is white to off-white. The suspension is pH neutral (approximately 7.0).

Osmolality 220-320 mOsm/Kg.

Qualitative and quantitative composition

Each pre-filled syringe contains paliperidone palmitate equivalent to 25 mg paliperidone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Paliperidone

Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics. Even though paliperidone is a strong D2-antagonist, which is believed to relieve the positive symptoms of schizophrenia, it causes less catalepsy and decreases motor functions to a lesser extent than traditional neuroleptics.

List of Excipients

Polysorbate 20
Macrogol
Citric acid monohydrate
Disodium phosphate
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

Pre-filled syringe (cyclic-olefin-copolymer) with a plunger stopper, backstop, and tip cap (chlorobutyl rubber) with a 22G 1½-inch safety needle and a 23G 1-inch safety needle.

Pack sizes: Pack contains 1 pre-filled syringe and 2 needles.

Marketing authorization holder

Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

Marketing authorization dates and numbers

PA1142/040/001

Date of first authorisation: 4th March 2022

Drugs

Drug Countries
PALMEUX Ireland

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