PROZAC

This brand name is authorized in Australia, Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Israel, Italy, Malta, Mexico, Netherlands, New Zealand, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Fluoxetine UNII I9W7N6B1KJ - FLUOXETINE HYDROCHLORIDE

Fluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism of action. Fluoxetine has practically no affinity to other receptors such as α1, α2, and β-adrenergic; serotonergic; dopaminergic; histaminergic1; muscarinic; and GABA receptors. Read about Fluoxetine

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PROZAC Capsule	FDA, National Drug Code (US)	MPI, US: SPL/PLR
PROZAC Hard capsules / Oral solution	Medicines & Healthcare Products Regulatory Agency (GB)	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
N06AB03	Fluoxetine	N Nervous system → N06 Psychoanaleptics → N06A Antidepressants → N06AB Selective serotonin reuptake inhibitors
Discover more medicines within N06AB03

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): 1434L
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 507602301113311, 507602302111310, 507602307111319, 507616080019903
Country: CA	Health Products and Food Branch	Identifier(s): 00636622, 02018985
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 29220-04-10
Country: EE	Ravimiamet	Identifier(s): 1070402, 1612886, 1836019
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 57954
Country: FR	Base de données publique des médicaments	Identifier(s): 61885224
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 162297
Country: HK	Department of Health Drug Office	Identifier(s): 30503
Country: IE	Health Products Regulatory Authority	Identifier(s): 38458, 39099, 42522, 43237, 43480
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 746
Country: IT	Agenzia del Farmaco	Identifier(s): 025970029, 025970043, 025970056, 039430018
Country: MT	Medicines Authority	Identifier(s): AA908/14602
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 120M88
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 68039
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 5112
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W10228001, W10228002
Country: SG	Health Sciences Authority	Identifier(s): 03027P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699673150031, 8699673150116, 8699673656021
Country: US	FDA, National Drug Code	Identifier(s): 0777-3104, 0777-3105, 0777-3107
Country: ZA	Health Products Regulatory Authority	Identifier(s): 30/1.2/0503, S/1.2/68