Fluoxetine

Sold as Lilly-fluoxetine, Lorien, Fluoxetine biotech, Seronil, Modipran, Fluoxetine oethmaan, Nuzak, Trio-fluoxetine, Deprozan, Fluoxetine actor, Ranflocs, Rezak, Cipla-fluoxetine, Zydus-fluoxetine, Trizac, Flocsive, Defiton, Prolax, Prozac

C₁₇H₁₈F₃NO309.33 g/mol

N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine

Drag to rotate. Structure from PubChem CID 3386.

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Registration

Applicants: 14
Registrations: 23
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Eli Lilly (S.A.) (Pty) LtdCancelled	Lilly-fluoxetine, Prozac	20	290491, S0068	S5	None
Pharmacare limited û woodmeadCertificate held by Pharmacare limited	Lorien, Trio-fluoxetine	20 mg, tablets	300024, 330043, 340381	S5	PI PIL
Biotech Laboratories (Pty) Ltd	Fluoxetine biotech, Defiton	20 mg	300356, 590262	S5	PI PIL
Alliance Pharma (Pty) Ltd	Seronil	20 mg	300397	S5	None
Ipharma (Pty) Ltd	Modipran	20 mg, 40	310638, 320103, 320104	S5	PI PIL
Oethmaan Biosims (Pty) Ltd	Fluoxetine oethmaan	20	320040	S5	None
Cipla Medpro (Pty) Ltd2 of 4 cancelled	Nuzak, Fluoxetine actor, Cipla-fluoxetine	20 mg, oral solution	320384, 340094, 370156, 370157	S5	PI PIL
Elttab Pharmaceuticals CC	Deprozan	Not stated	330541	S5	None
Ranbaxy (SA) (Pty) LtdCancelled	Ranflocs	20	340129	S5	None
Dr Reddyæs Laboratories (Pty) LtdCancelled	Rezak	Not stated	340279	S5	None
Zydus Healthcare (Pty) Ltd	Zydus-fluoxetine	20 mg	370265	S5	None
Unichem SA (Pty) LtdCancelled	Trizac	20 mg	370612	S5	None
Pharma-q (Pty) Ltd	Flocsive	20 mg	580187	S5	PI PIL
Dezzo Trading 392 (Pty) Ltd	Prolax	capsules	A380413	S5	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Lilly-fluoxetine 20 CAPSULE FLUOXETINE HYDROCHLORIDE 22,36 MG	20	29049129/1.2/0491	Cancelled	S5	None
Lorien EACH CAPSULE CONTAINS :FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20 mg	20 mgCapsules	30002430/1.2/0024Approved 27 June 2021	Registered	S5	PI PIL
Fluoxetine 20 biotech EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE A EQUIVALENT TO 20,0 mg FLUOXETINE	20 mgCapsules. Hard.	30035630/1.2/0356Approved 30 April 2026	Registered	S5	PI PIL
Seronil 20 MG EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20 mg	20 mg	30039730/1.2/0397	Registered	S5	None
Modipran 20 capsules EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	20 mgCapsules, hard.	31063831/1.2/0638Approved 4 July 2023	Registered	S5	PI PIL
Fluoxetine 20 oethmaan EACH CAPSULE CONTAINS FLUOXETINE 20,0 mg	20	32004032/1.2/0040	Registered	S5	None
Modipran 20 tablets EACH TABLET CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	20Tablets	32010332/1.2/0103	Registered	S5	None
Modipran 40 tablets EACH TABLET CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 40,0 mg	40Tablets	32010432/1.2/0104	Registered	S5	None
Nuzak EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	20 mgCapsules	32038432/1.2/0384Approved 5 May 2026	Registered	S5	PI PIL
Trio-fluoxetine EACH CAPSULE CONTAINS :FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20, 0 mg	Not listed	33004333/1.2/0043	Registered	S5	None
Deprozan EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	Not listed	33054133/1.2/0541	Registered	S5	None
Fluoxetine actor 20 EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	20	34009434/1.2/0094	Cancelled	S5	None
Ranflocs 20 capsules EACH CAPSULE CONTAINS :FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	20Capsules	34012934/1.2/0129	Cancelled	S5	None
Rezak EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	Not listed	34027934/1.2/0279	Cancelled	S5	None
Lorien tablets EACH TABLET CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	Tablets	34038134/1.2/0381	Registered	S5	None
Nuzak oral solution EACH 5,0 ml SOLUTION CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	Oral solution	37015637/1.2/0156	Cancelled	S5	None
Cipla-fluoxetine oral solution EACH 5,0 ml SOLUTION CONTAINS FLUOXETINE HYDROCHLORIDE 20,0 mg	Oral solution	37015737/1.2/0157	Registered	S5	None
Zydus-fluoxetine 20 MG EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	20 mg	37026537/1.2/0265	Registered	S5	None
Trizac 20 MG EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE A EQUIVALENT TO FLUOXETINE 20,0 mg	20 mg	37061237/1.2/0612	Cancelled	S5	None
Flocsive 20 EACH CAPSULE CONTAINS: FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	20 mgCapsules	58018758/1.2/0187Approved 14 July 2026	Registered	S5	PI PIL
Defiton 20 EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	20 mgCapsules, hard	59026259/1.2/0262Approved 30 April 2026	Registered	S5	PI PIL
Prolax capsules EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20,0 mg	Capsules	A380413A38/1.2/0413	Registered	S5	None
Prozac 20 EACH CAPSULE CONTAINS FLUOXETINE HYDROCHLORIDE EQUIVALENT TO FLUOXETINE 20 mg	20	S0068S/1.2/68	Cancelled	S5	None

Regulatory status

Where S5 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only, with tighter controls on repeats.

Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S5, matched to the Consolidated Schedules by ingredient, confidence high.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.

Consolidated Schedules listings for Fluoxetine hydrochloride

S5: Fluoxetine
Consolidated Schedules 06 July 2026, line 9445

Pharmacological class: Psychoanaleptics (antidepressants). (class 1.2)

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Lorien, Pharmacare limited û woodmead is scheduled S5 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsLorien, Pharmacare limited û woodmead Patient information leaflet (PIL)For patients and carersLorien, Pharmacare limited û woodmead

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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