Isotretinoin Sandoz

Medicinal product

(Invented) name

Isotretinoin Sandoz

Active substance (s)

Izotretinoinas

Strength

5 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

Sandoz d.d., Slovėnija

Date of authorisation

2020-05-13

Date of renewal

2024-08-14

Documents

Isotretinoin Sandoz vaistininko klausimynas.pdf

4570-4572_pakuotes lapelis_2024-08-14.docx

Isotretinoin Sandoz gydytojo klausimynas.pdf

4570_4572 Isotretinoin Sandoz PCS 2024 12 05.docx

Isotretinoin Sandoz paciento priminimo kortelė.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/4820/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Izotretinoinas	5 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
104072	90176	1090176	lizdinė plokštelė	N30		Receptinis	LT/1/20/4570/001	Netiekiama	-	-	No	-	-
104073	90177	1090177	lizdinė plokštelė	N100		Receptinis	LT/1/20/4570/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-14	Perregistruotas
2020-05-13	Registruotas