This brand name is authorized in Nigeria. It is also authorized in Austria, Croatia, Cyprus, Estonia, Finland, France, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Spain, Turkey, UK.
The drug TREVICTA contains one active pharmaceutical ingredient (API):
1
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UNII
R8P8USM8FR - PALIPERIDONE PALMITATE
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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. |
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
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A4-100553 | Suspension for injection | TREVICTA 263 mg prolonged release suspension for injection INJ_SUSP 263mg 1 X 1 | 48 NF-PP-268959 TREVICTA 263 mg prolonged release suspension for injection Paliperidone palmitate Each TREVICTA 263 mg pre filled syringe contains 410 mg paliperidone palmitate The other ingredients are: Polysorbate 20 Polyethylene glycol 4000 Citric acid monohydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections A4-100553 Drugs Imported Products 11 Prescription Only Medicine (POM) 7/17/2023 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 uugwulek@its.jnj.com JANSSEN PHARMACEUTICA N.V, TURNHOUTSEWEG 30, B-2340 BEERSE, BELGIUM, Belgium | 31/10/2023 |
A4-100554 | Suspension for injection | TREVICTA 175mg prolonged release suspension for injection INJ_SUSP 175mg 1 X 1 | 49 NF-PP-268978 TREVICTA 175mg prolonged release suspension for injection Paliperidone palmitate Each prefilled syringe contains 273 mg paliperidone palmitate equivalent to 175 mg paliperidone. Excipients include Polysorbate 20 Polyethylene glycol 4000 Citric acid monohydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections A4-100554 Drugs Imported Products 11 Prescription Only Medicine (POM) 7/17/2023 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 uugwulek@its.jnj.com JANSSEN PHARMACEUTICA N.V, TURNHOUTSEWEG 30, B-2340 BEERSE, BELGIUM, Belgium | 31/10/2023 |
A4-100578 | Suspension for injection | TREVICTA 525 MG PROLONGED RELEASE SUSPENSION FOR INJECTION INJ_SUSP 525mg 1 X 1 | 72 NF-PP-341933 TREVICTA 525 MG PROLONGED RELEASE SUSPENSION FOR INJECTION Paliperidone Palmitate Each pre filled syringe contains 819 mg paliperidone palmitate equivalent to 525 mg paliperidone. Excipients include: Polysorbate 20 Polyethylene glycol 4000 Citric acid monohydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections A4-100578 Drugs Imported Products 11 Prescription Only Medicine (POM) 7/17/2023 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 uugwulek@its.jnj.com JANSSEN PHARMACEUTICA N.V, TURNHOUTSEWEG 30, B-2340 BEERSE, BELGIUM, Belgium | 31/10/2023 |
A4-100677 | Injection | TREVICTA 350 MG PROLONGED RELEASE SUSPENSION FOR INJECTION INJ 350mg 1 X 1 | 27 NF-PP-341930 TREVICTA 350 MG PROLONGED RELEASE SUSPENSION FOR INJECTION Paliperidone Palmitate Each prefilled syringe contains 546 mg paliperidone palmitate equivalent to 350 mg paliperidone. Excipients include Polysorbate 20 Polyethylene glycol 4000 Citric acid monohydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections A4-100677 Drugs Imported Products 11 Prescription Only Medicine (POM) 7/17/2023 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 uugwulek@its.jnj.com JANSSEN PHARMACEUTICA N.V, TURNHOUTSEWEG 30, B-2340 BEERSE, BELGIUM, Belgium | 21/12/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
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N05AX13 | Paliperidone | N Nervous system → N05 Psycholeptics → N05A Antipsychotics → N05AX Other antipsychotics |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
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EE | Ravimiamet | 1721360, 1721371, 1721382, 1721393 |
ES | Centro de información online de medicamentos de la AEMPS | 114971007, 114971008, 114971009, 114971010 |
FI | Lääkealan turvallisuus- ja kehittämiskeskus | 415635, 440410, 493496, 527714 |
FR | Base de données publique des médicaments | 60249796, 61444322, 68924929, 69642982 |
GB | Medicines & Healthcare Products Regulatory Agency | 328670, 328679, 328682, 328685 |
IE | Health Products Regulatory Authority | 34240, 34241, 34242, 34243, 62898 |
IL | מִשְׂרַד הַבְּרִיאוּת | 7921, 7922, 7923, 7924 |
IT | Agenzia del Farmaco | 043799079, 043799081, 043799093, 043799105 |
LT | Valstybinė vaistų kontrolės tarnyba | 1080478, 1080479, 1080480, 1080481 |
NG | Registered Drug Product Database | A4-100553, A4-100554, A4-100578, A4-100677 |
NL | Z-Index G-Standaard, PRK | 132535, 132551, 132578, 136204 |
PL | Rejestru Produktów Leczniczych | 100372448, 100372454, 100372460, 100372477 |
RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W62903001, W62904001, W62905001, W62906001 |
TR | İlaç ve Tıbbi Cihaz Kurumu | 8699593950087, 8699593950094, 8699593950100, 8699593950117 |
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