TEGRETOL

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

Active ingredients

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

1	Carbamazepine UNII 33CM23913M - CARBAMAZEPINE
	Carbamazepine is a derivative of dibenzazepine. It belongs to the pharmaceutical class of antiepileptic, neurotropic and psychotropic drugs. Carbamazepine helps control the transmission of messages from the brain to the muscles.
	Read more about Carbamazepine

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-0024	Tablet	Tegretol Tablets 200mg TAB 200 mg 5 X 10	Tegretol Tablets 200mg Carbamazepine 200mg Carbamazepine 200mg Excipients: Silica, colloidal anhydrous, cellulose microcrystalline, magnesium stearate, carmellose sodium, low substituted. 04-0024 Drugs Imported Products 510 Prescription Only Medicine (POM) 5/3/2022 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS 2.34707E+12 nguavese.saror@novartis.com Novartis Farma S.P.A, Novartis Farma S.P.A Torre Annunziata, Italy, Italy	25/05/2023
04-0037	Tablet	Tegretol® CR Tablets TAB 200 mg 5 X 10	22 RNW-PP-46049 Tegretol® CR Tablets 200mg Carbamazepine CR 200mg Carbamazepine 200mg Excipients: Silica, colloidal anhydrous), ethylcellulose aqueous dispersion, cellulose microcrystalline, polyacrylate dispersion, magnesium stearate, croscarmellose sodium, talc. Coating: hypromellose, macrogolglycerol hydroxystearate, iron oxide red, iron oxide yellow, talc, titanium dioxide 04-0037 Drugs NERVOUS SYSTEM Imported Products 510 Prescription Only Medicine (POM) 5/3/2022 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS 2.34707E+12 arit.onwusah@novartis.com Novartis Farma S.P.A, Novartis Farma S.P.A Torre Annunziata, Italy, Italy	28/03/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
Tegretol Tablets 100mg, 200mg, 400mg	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
N03AF01	Carbamazepine	N Nervous system → N03 Antiepileptics → N03A Antiepileptics → N03AF Carboxamide derivatives
Discover more medicines within N03AF01

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	1706T, 1724R, 2422L, 2426Q, 2427R, 2431Y, 5037D, 5038E, 5039F, 5041H
BR	Câmara de Regulação do Mercado de Medicamentos	526515001134310, 526515002114313, 526515003110311, 526515004117311, 526515005113318, 526515006111319, 526515007116314, 526526601111414
CA	Health Products and Food Branch	00010405, 00755583, 00773611, 02194333
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	110-MEE-0214, 25.923-09-04, 28238-08-07, 28386-02-08
EE	Ravimiamet	1008009, 1009358, 1828717
ES	Centro de información online de medicamentos de la AEMPS	39955, 56232
FI	Lääkealan turvallisuus- ja kehittämiskeskus	119198, 157863, 168716, 168740, 168971, 414789
FR	Base de données publique des médicaments	61009918, 63045724, 65608566, 67655493
GB	Medicines & Healthcare Products Regulatory Agency	139859, 139868, 139878, 146243, 146246, 146249, 15618, 15665, 15699, 162640, 162646, 162649, 162678, 166780, 181963, 181965, 20827, 20862, 21439, 379980, 379982
HK	Department of Health Drug Office	35117, 44772, 44773
HR	Agencija za lijekove i medicinske proizvode	HR-H-101206989, HR-H-334072270
IE	Health Products Regulatory Authority	24295, 48172, 48706, 48739, 48999, 67482
IL	מִשְׂרַד הַבְּרִיאוּת	602, 603, 604, 605
IT	Agenzia del Farmaco	020602013, 020602025
JP	医薬品医療機器総合機構	1139002C1082, 1139002F1062, 1139002F2026
LT	Valstybinė vaistų kontrolės tarnyba	1003739, 1003740
MT	Medicines Authority	MA1249/01501, MA1249/01502, MA1249/01503, MA1249/01504
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	054M88, 64445, 76957
NG	Registered Drug Product Database	04-0024, 04-0037, 04-7592
NL	Z-Index G-Standaard	12151955
NL	Z-Index G-Standaard, PRK	20826, 25976, 25984, 515, 7579
NZ	Medicines and Medical Devices Safety Authority	382, 383, 384, 385, 386
PL	Rejestru Produktów Leczniczych	100065947, 100065953, 100195153
SG	Health Sciences Authority	00352P, 00510P, 02387P, 02388P
TN	Direction de la Pharmacie et du Médicament	10283041, 10283042, 10283044
TR	İlaç ve Tıbbi Cihaz Kurumu	8699504010114, 8699504010121, 8699504030051, 8699504030075
US	FDA, National Drug Code	0078-0508, 0078-0509, 0078-0510, 0078-0511, 0078-0512, 70518-0337
ZA	Health Products Regulatory Authority	D/2.5/204, V/2.5/321, V/2.5/322