BYANNLI Prolonged-release suspension for injection Ref.[50946] Active ingredients: Paliperidone

Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

BYANNLI 700 mg prolonged-release suspension for injection in pre-filled syringe.

BYANNLI 1 000 mg prolonged-release suspension for injection in pre-filled syringe.

Pharmaceutical Form
Prolonged-release suspension for injection (injection). The suspension is white to off-white. The suspension is pH neutral (approximately 7.0).

Qualitative and quantitative composition

700 mg prolonged-release suspension for injection: Each pre-filled syringe contains 1 092 mg paliperidone palmitate equivalent to 700 mg paliperidone.

1 000 mg prolonged-release suspension for injection: Each pre-filled syringe contains 1 560 mg paliperidone palmitate equivalent to 1 000 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 4 000 Citric acid monohydrate 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, plunger rod, backstop, and tip cap (bromobutyl rubber) with a thin wall 20G 1½ inch (0.9 mm × 38 mm) safety needle.

Pack sizes: Pack contains 1 pre-filled syringe and 1 needle.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/20/1453/007
EU/1/20/1453/008

Date of first authorisation: 18 June 2020

Drugs

Drug	Countries
BYANNLI	Croatia, Ireland, Poland, Romania

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