CONCERTA

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

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 more about Methylphenidate

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	2172H, 2387P, 2388Q, 2432B
BR	Câmara de Regulação do Mercado de Medicamentos	514500301117310, 514500302113319, 514500303111417
CA	Health Products and Food Branch	02247732, 02247733, 02247734, 02250241
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	02842045, 02842051, 02842068, 06876153, 12459057
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1675-MEE-0116, 1709-MEE-0116, 1730-MEE-0116, 1731-MEE-0116
EE	Ravimiamet	1313558, 1313569, 1313570, 1313581, 1313659, 1313660
ES	Centro de información online de medicamentos de la AEMPS	65148, 65170, 65171, 69988
FI	Lääkealan turvallisuus- ja kehittämiskeskus	011489, 011555, 012326, 132663
FR	Base de données publique des médicaments	60047182, 60756917, 63930084
GB	Medicines & Healthcare Products Regulatory Agency	114650, 26470, 26471, 289431, 373870, 373874, 373878, 374088, 376261, 376263, 376265, 376267, 381263, 381265, 381267, 381269
HK	Department of Health Drug Office	60002, 60003, 60004, 60005
HR	Agencija za lijekove i medicinske proizvode	HR-H-078951991, HR-H-413338677
IE	Health Products Regulatory Authority	16901, 16988, 18113
IL	מִשְׂרַד הַבְּרִיאוּת	4626, 4627, 4832, 4982
JP	医薬品医療機器総合機構	1179009G1022, 1179009G2029, 1179009G3025
LT	Valstybinė vaistų kontrolės tarnyba	1026826, 1026827, 1026828, 1027108, 1027109, 1027110
MT	Medicines Authority	AA018/02604, MA018/02601, MA018/02602, MA018/02603
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	136M2002
NG	Registered Drug Product Database	B4-8146, B4-8147
NL	Z-Index G-Standaard, PRK	68004, 68012, 69272, 87076
NZ	Medicines and Medical Devices Safety Authority	10792, 10793, 10794, 12323
PL	Rejestru Produktów Leczniczych	100196827, 100196833
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W43107001, W43107002, W43108001, W43108002, W43109001, W43109002
SG	Health Sciences Authority	12098P, 12099P, 12100P, 12431P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593035517, 8699593035524, 8699593035531, 8699593035753
US	FDA, National Drug Code	50458-585, 50458-586, 50458-587, 50458-588
ZA	Health Products Regulatory Authority	37/1.2/0322, 37/1.2/0323, 37/1.2/0324, 42/1.2/0282