PROZAC

Medicinal product

(Invented) name

PROZAC

Active substance (s)

Fluoksetinas

Strength

20 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N06AB03, Fluoxetine

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2025-01-17

Date of renewal

Documents

2333_PROZAC_20mg_kiet_kaps_PZ.docx

2333_PROZAC_20mg_kiet_kaps_PIL.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Fluoksetinas	20 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
116314	102416	1102416	lizdinė plokštelė	N28		Receptinis	LT/L/25/2333/001	Tiekiama	2025-05-17	-	No	-	-	Download

Stadijos

Data	Stadija
2025-01-17	Registruotas