Axotret

Medicinal product

(Invented) name

Axotret

Active substance (s)

Izotretinoinas

Strength

20 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D10BA01, Isotretinoin

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2024-11-29

Date of renewal

Documents

2259_2260_Axotret 10mg_20mg_mink_kaps_PL_2024-11-29.docx

2260_Axotret 20mg_mink_kaps_PZ_2024-11-29.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.
Izotretinoinas	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
115889	101994	1101994	lizdinė plokštelė	N30		Receptinis	LT/L/24/2260/001	Tiekiama	2025-04-29	-	No	-	-
115890	101995	1101995	lizdinė plokštelė	N60		Receptinis	LT/L/24/2260/002	Tiekiama	2025-04-24	-	No	-	-	Download

Stadijos

Data	Stadija
2024-11-29	Registruotas