Aklief

Medicinal product

(Invented) name

Aklief

Active substance (s)

Trifarotenas

Strength

50 µg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D10AD06, Trifarotene

Marketing authorisation holder

Laboratoires Galderma, Prancūzija

Date of authorisation

2021-11-24

Date of renewal

2024-10-09

Documents

4855_Aklief_perr2024-10-09+II_008.docx

4855_pakuotes lapelis_2024-10-09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1863/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 g kremo yra:	1 g
Trifarotenas	50 µg

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
107600	93705	1093705	tūbelė	5 g N1		Receptinis	LT/1/21/4855/001	Netiekiama	-	-	No	-	-
107601	93706	1093706	daugiadozė talpyklė su sandariąja pompa	15 g N1		Receptinis	LT/1/21/4855/002	Netiekiama	-	-	No	-	-
107602	93707	1093707	daugiadozė talpyklė su sandariąja pompa	30 g N1		Receptinis	LT/1/21/4855/003	Netiekiama	-	-	No	-	-
107603	93708	1093708	daugiadozė talpyklė su sandariąja pompa	75 g N1		Receptinis	LT/1/21/4855/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-09	Perregistruotas
2021-11-24	Registruotas