Roaccutane

Medicinal product

(Invented) name

Roaccutane

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 Roche Lietuva, Lietuva

Date of authorisation

2006-04-14

Date of renewal

2010-03-31

Documents

0406 Pakuotės lapelis 2024 10 14.docx

Roaccutane gydytojo kontrolinis klausimynas.pdf

Roaccutane paciento priminimo kortele.pdf

0406 Roaccutane II PL 2024 10 14.docx

Roaccutane vaistininko kontrolinis klausimynas.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

EE/H/0271/002

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

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
16533	20563	1020563	lizdinė plokštelė	N30		Receptinis	LT/1/05/0406/006	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2010-03-31	Perregistruotas
2006-04-14	Registruotas