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