ZOLOFT

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

Active ingredients

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

1
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

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

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