CONCERTA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Methylphenidate
UNII 4B3SC438HI - METHYLPHENIDATE HYDROCHLORIDE

Methylphenidate HCl is a mild central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of noradrenaline and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space.

Read about Methylphenidate

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
CONCERTA Extended-release tablet Medicines and Medical Devices Safety Authority (NZ) MPI, EU: SmPC

Medicine classification

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

ATC code Group title Classification
N06BA04 Methylphenidate N Nervous system → N06 Psychoanaleptics → N06B Psychostimulants, agents used for ADHD and nootropics → N06BA Centrally acting sympathomimetics
Discover more medicines within N06BA04

Authorization and marketing

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

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 2172H, 2387P, 2388Q, 2432B
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 514500301117310, 514500302113319, 514500303111417
Country: CA Health Products and Food Branch Identifier(s): 02247732, 02247733, 02247734, 02250241
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 02842045, 02842051, 02842068, 06876153, 12459057
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 1675-MEE-0116, 1709-MEE-0116, 1730-MEE-0116, 1731-MEE-0116
Country: EE Ravimiamet Identifier(s): 1313558, 1313569, 1313570, 1313581, 1313659, 1313660
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 65148, 65170, 65171, 69988
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 011489, 011555, 012326, 132663
Country: FR Base de données publique des médicaments Identifier(s): 60047182, 60756917, 63930084
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 114650, 26470, 26471, 289431, 373870, 373874, 373878, 374088, 376261, 376263, 376265, 376267, 381263, 381265, 381267, 381269
Country: HK Department of Health Drug Office Identifier(s): 60002, 60003, 60004, 60005
Country: IE Health Products Regulatory Authority Identifier(s): 16901, 16988, 18113
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4626, 4627, 4832, 4982
Country: JP 医薬品医療機器総合機構 Identifier(s): 1179009G1022, 1179009G2029, 1179009G3025
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1026826, 1026827, 1026828, 1027108, 1027109, 1027110
Country: MT Medicines Authority Identifier(s): AA018/02604, MA018/02601, MA018/02602, MA018/02603
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 136M2002
Country: NG Registered Drug Product Database Identifier(s): B4-8146, B4-8147
Country: NL Z-Index G-Standaard, PRK Identifier(s): 68004, 68012, 69272, 87076
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 10792, 10793, 10794, 12323
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100196827, 100196833
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W43107001, W43107002, W43108001, W43108002, W43109001, W43109002
Country: SG Health Sciences Authority Identifier(s): 12098P, 12099P, 12100P, 12431P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699593035517, 8699593035524, 8699593035531, 8699593035753
Country: US FDA, National Drug Code Identifier(s): 50458-585, 50458-586, 50458-587, 50458-588
Country: ZA Health Products Regulatory Authority Identifier(s): 37/1.2/0322, 37/1.2/0323, 37/1.2/0324, 42/1.2/0282

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