XEPLION Prolonged release suspension for injection Ref.[7473] Active ingredients: Paliperidone

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

Xeplion 25 mg prolonged release suspension for injection.

Xeplion 50 mg prolonged release suspension for injection.

Xeplion 75 mg prolonged release suspension for injection.

Xeplion 100 mg prolonged release suspension for injection.

Xeplion 150 mg prolonged release suspension for injection.

Pharmaceutical Form

Prolonged release suspension for injection.

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

Qualitative and quantitative composition

25 mg prolonged release suspension for injection: Each pre-filled syringe contains 39 mg paliperidone palmitate equivalent to 25 mg paliperidone.

50 mg prolonged release suspension for injection: Each pre-filled syringe contains 78 mg paliperidone palmitate equivalent to 50 mg paliperidone.

75 mg prolonged release suspension for injection: Each pre-filled syringe contains 117 mg paliperidone palmitate equivalent to 75 mg paliperidone.

100 mg prolonged release suspension for injection: Each pre-filled syringe contains 156 mg paliperidone palmitate equivalent to 100 mg paliperidone.

150 mg prolonged release suspension for injection: Each pre-filled syringe contains 234 mg paliperidone palmitate equivalent to 150 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
Polyethylene glycol 4000
Citric acid monohydrate
Disodium hydrogen phosphate anhydrous
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 (bromobutyl rubber) with a 22G 1 1⁄2-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm).

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

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

EU/1/11/672/001 (25 mg)
EU/1/11/672/002 (50 mg)
EU/1/11/672/003 (75 mg)
EU/1/11/672/004 (100 mg)
EU/1/11/672/005 (150 mg)

Date of first authorisation: 04 March 2011
Date of latest renewal: 16 December 2015

Drugs

Drug Countries
XEPLION Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom

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