RISPERDAL

This brand name is authorized in United States. 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, Nigeria, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1
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

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
Switch country to Nigeria in order to find specific presentations of RISPERDAL
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

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