Roaccutane

Medicinal product

(Invented) name

Roaccutane

Active substance (s)

Izotretinoinas

Strength

10 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 Lex ano, Lietuva

Date of authorisation

2018-06-18

Date of renewal

Documents

0668_Roaccutane 10 mg_PZPL_2019-01-24.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	10 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
99682	85789	1085789	lizdinė plokštelė	N30		Receptinis	LT/L/18/0668/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-06-18	Registruotas