PROZAC

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

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 more about Fluoxetine

Medication package inserts

Below package inserts are available for further reading:

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