ZOLOFT

This brand name is authorized in Nigeria. It is also authorized in Australia, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Tunisia, United States.

Active ingredients

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

1	Sertraline UNII UTI8907Y6X - SERTRALINE HYDROCHLORIDE
	Sertraline is a potent and specific inhibitor of neuronal serotonin (5-HT) uptake in vitro, which results in the potentiation of the effects of 5-HT in animals. It has only very weak effects on norepinephrine and dopamine neuronal reuptake.
	Read more about Sertraline

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-2796	Capsule	Zoloft 50 mg Capsules CAP 50 mg	Hard capsule	30/11/2020

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ZOLOFT Film-coated tablet / Oral solution	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

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

ATC Group		Classification
N06AB06	Sertraline	N Nervous system → N06 Psychoanaleptics → N06A Antidepressants → N06AB Selective serotonin reuptake inhibitors
Discover more medicines within N06AB06

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	2236Q, 2237R, 8836C, 8837D
BR	Câmara de Regulação do Mercado de Medicamentos	552820020063517, 552820020063617, 552820020063717, 552820020063817, 552820020063917, 552820020064017
CA	Health Products and Food Branch	01962779, 01962817, 02132702
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00253818, 00253830, 01041490, 01511062, 01883734, 01883740, 02711426, 02743136, 02743165, 02743975, 03497366, 03499425, 07544068, 07577837, 07577843
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	20.986-1-02-04, 4679-MEE-0419, 6107-MEE-0421
EE	Ravimiamet	1008638, 1669181, 1669192, 1669204, 1669215, 1669226, 1669237, 1669248, 1669259, 1669260, 1669271, 1669282, 1669293, 1669305, 1669316, 1669327, 1831968
FI	Lääkealan turvallisuus- ja kehittämiskeskus	037697, 037879, 037994, 038091
FR	Base de données publique des médicaments	60155788, 60683198
HK	Department of Health Drug Office	36350
HR	Agencija za lijekove i medicinske proizvode	HR-H-153369585
IT	Agenzia del Farmaco	027753033, 027753045, 027753108, 027753110
LT	Valstybinė vaistų kontrolės tarnyba	1002230, 1019935, 1061976, 1061977, 1061978, 1061979, 1061980, 1061981, 1061982, 1061983, 1061984, 1061985, 1061986, 1061987, 1061988, 1061989, 1069176, 1086930, 1088370
NG	Registered Drug Product Database	04-2796
NL	Z-Index G-Standaard	14664992
NL	Z-Index G-Standaard, PRK	39403, 59633
NZ	Medicines and Medical Devices Safety Authority	5856, 5859
PL	Rejestru Produktów Leczniczych	100079719, 100079725
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67278001, W67278002, W67278003, W67278004, W67278005, W67278006, W67278007, W67278008, W67278009, W67278010, W67278011, W67278012, W67278013, W67278014, W67278015, W67278016, W67278017, W67279001, W67279002, W67279003, W67279004, W67279005, W67279006, W67279007, W67279008, W67279009, W67279010, W67279011, W67279012, W67279013, W67279014, W67279015, W67279016, W67279017, W67280001
SG	Health Sciences Authority	07301P, 07302P
TN	Direction de la Pharmacie et du Médicament	9243141, 9243142
US	FDA, National Drug Code	0049-0050, 0049-4900, 0049-4910, 0049-4960, 55289-409, 70518-1913
ZA	Health Products Regulatory Authority	32/1.2/0381