RISPERDAL

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Canada, Cyprus, Ecuador, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Singapore, South Africa, Spain, Turkey, UK, United States.

Active ingredients

The drug RISPERDAL contains one active pharmaceutical ingredient (API):

1	Risperidone UNII L6UH7ZF8HC - RISPERIDONE
	Risperidone is a selective monoaminergic antagonist with unique properties. Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics.
	Read more about Risperidone

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-2990	Tablet	RISPERDAL 2 MG TABLET TAB 2 mg 2X10	42 RNW-PP-276908 RISPERDAL 2 MG TABLET RISPERIDONE API- Risperidone 2mg, Excipients include: Tablet core Lactose monohydrate Maize starch Cellulose microcrystalline (E460) Hypromellose (E464) Magnesium stearate (Ph. Eur.) Silica colloidal anhydrous Sodium laurilsulfate Film coating Hypromellose (E464) Propylene glycol (E490) Titanium dioxide (E171) Talc (E553B) Orange yellow S aluminium lake (E110) Apr-90 Drugs Imported Products 210 Prescription Only Medicine (POM) 8/15/2022 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 DL-CONZACTCTRegulatoryAffairs@JNJZA.JNJ.com JANSSEN CILAG S.P.A, Via C Janssen Borgo S. Michelle 04010 Latina Italy, Italy	06/07/2023
04-2998	Tablet	RISPERDAL 3MG TABLET TAB 3 mg 2X10	41 RNW-PP-276933 RISPERDAL 3MG TABLET RISPERIDONE Risperidone, Excipients include: Tablet core Lactose monohydrate Maize starch Cellulose microcrystalline (E460) Hypromellose (E464) Magnesium stearate (Ph. Eur.) Silica colloidal anhydrous Sodium laurilsulfate Film coating Hypromellose (E464) Propylene glycol (E490) Titanium dioxide (E171) Talc (E553B) Quinoline yellow (E104 Apr-98 Drugs Imported Products 210 Prescription Only Medicine (POM) 8/16/2022 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 DL-CONZACTCTRegulatoryAffairs@JNJZA.JNJ.com JANSSEN CILAG S.P.A V.C. JANSSEN [FOR JANSSEN PHARMA NV], JANSSEN CILAG S.P.A V.C JANSSEN BORGOS, MICHELE,04010 LATINA, ITALY, Italy	06/07/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
RISPERDAL Tablet / Tablet orally disintegrating / Solution	MPI, US: SPL/PLR	FDA, National Drug Code (US)
RISPERDAL CONSTA Powder and solvent for suspension for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
N05AX08	Risperidone	N Nervous system → N05 Psycholeptics → N05A Antipsychotics → N05AX Other antipsychotics
Discover more medicines within N05AX08

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	11872W, 11873X, 11874Y, 11877D, 11879F, 11882J, 1842Y, 1846E, 3169T, 3170W, 3171X, 3172Y, 8100H, 8780D, 8781E, 8782F, 8789N, 9079W, 9293D
BR	Câmara de Regulação do Mercado de Medicamentos	514504201117311, 514504203136313, 514504204116316, 514504205112314, 514505701113313, 514505801118317, 514507104155314, 514507105151312, 514507106158310, 514518050034503, 514518050034603, 514518050034703
CA	Health Products and Food Branch	02236950, 02255707, 02255723, 02255758, 02298465
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00596085, 01816086, 01816146, 01816152, 01816181, 07700640
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	22.431-1-03-05, 24.467-1-03-12, 24.468-05-02, 24.469-1-03-12, 26.160-02-05, 26.161-02-05, 26.162-02-05, 26.887-02-06
ES	Centro de información online de medicamentos de la AEMPS	60335, 60336, 62096, 62803, 65213, 65214, 65215
FI	Lääkealan turvallisuus- ja kehittämiskeskus	000005, 070020, 070031, 070042, 070797, 567263, 567503, 567511, 567529, 567537
FR	Base de données publique des médicaments	60260497, 63605525, 65893318, 68878549, 68901873, 69505147, 69556750
GB	Medicines & Healthcare Products Regulatory Agency	146611, 162347, 162349, 162351, 162353, 162355, 198598, 368736, 368738, 368740, 398347, 41668, 41671, 45208
HK	Department of Health Drug Office	42267, 50820, 50821, 50822, 50823, 51039, 51040, 51064
IE	Health Products Regulatory Authority	29204, 44013, 44020, 44062, 44089, 44090, 44094, 44132, 44226, 45224, 45232, 45492, 45493, 45494
IL	מִשְׂרַד הַבְּרִיאוּת	3050, 3051, 3052, 3113, 4122, 4612, 4613, 4614
IT	Agenzia del Farmaco	028752057, 028752069, 028752071, 028752083, 028752095
JP	医薬品医療機器総合機構	1179038C1027, 1179038F1023, 1179038F2020, 1179038F3026, 1179038F5029, 1179038F6025, 1179038F7021, 1179407G1026, 1179407G2022, 1179407G3029
MT	Medicines Authority	MA018/00201, MA018/00202, MA018/00203, MA018/00204, MA018/00205, MA018/00206, MA018/00207
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	039M95, 098M93, 270M2002, 589M2002
NG	Registered Drug Product Database	04-2990, 04-2998
NL	Z-Index G-Standaard	14001098
NL	Z-Index G-Standaard, PRK	116939, 116947, 116955, 37710, 37729, 37737, 37745, 44016, 56197
NZ	Medicines and Medical Devices Safety Authority	10531, 10532, 10533, 6753, 6754, 6756, 6757, 6758, 8535
SG	Health Sciences Authority	08058P, 08061P, 09905P, 12354P, 12355P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593091148, 8699593091155, 8699593091162, 8699593091179, 8699593595059, 8699593781018, 8699593781025, 8699593781032
US	FDA, National Drug Code	50458-300, 50458-301, 50458-302, 50458-305, 50458-315, 50458-320, 50458-325, 50458-330, 50458-335, 50458-350, 50458-355, 50458-395, 55289-463, 55289-465, 55289-491, 55289-519, 70518-1763, 70518-2160, 70518-2161
ZA	Health Products Regulatory Authority	30/2.6.5/0215, 37/2.6.5/0142, 37/2.6.5/0144, 37/2.6.5/0320, 37/2.6.5/0321, A40/2.6.5/0204, A40/2.6.5/0205