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

2024-05-27

Date of renewal

Documents

2161_PROZAC 20mg_kiet_kaps_PZPL_2024-05-27.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
113779	99896	1099896	lizdinė plokštelė	N28		Receptinis	LT/L/24/2161/001	Netiekiama	-	-	No	-	-	Download
113780	99897	1099897	lizdinė plokštelė	N56		Receptinis	LT/L/24/2161/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-27	Registruotas