Frondava

Medicinal product

(Invented) name

Frondava

Active substance (s)

Mometazono furoatas

Strength

1 mg/g

Pharmaceutical form

tepalas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D07AC13, Mometasone

Marketing authorisation holder

Almirall Hermal GmbH, Vokietija

Date of authorisation

2015-06-16

Date of renewal

Documents

3739_1-11 Frondava_tep-DP.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g tepalo yra	1 g
Mometazono furoatas	1 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
58498	72663	1072663	tūbelė	10 g N1		Receptinis	LT/1/15/3739/001	Netiekiama	-	-	No	-	-
62481	76890	1076890	tūbelė	15 g N1		Receptinis	LT/1/15/3739/002	Netiekiama	-	-	No	-	-
62482	76891	1076891	tūbelė	20 g N1		Receptinis	LT/1/15/3739/003	Netiekiama	-	-	No	-	-
62483	76892	1076892	tūbelė	25 g N1		Receptinis	LT/1/15/3739/004	Netiekiama	-	-	No	-	-
62484	76893	1076893	tūbelė	30 g N1		Receptinis	LT/1/15/3739/005	Netiekiama	-	-	No	-	-
62485	76894	1076894	tūbelė	35 g N1		Receptinis	LT/1/15/3739/006	Netiekiama	-	-	No	-	-
62486	76895	1076895	tūbelė	50 g N1		Receptinis	LT/1/15/3739/007	Netiekiama	-	-	No	-	-
62487	76896	1076896	tūbelė	60 g N1		Receptinis	LT/1/15/3739/008	Netiekiama	-	-	No	-	-
62488	76897	1076897	tūbelė	70 g N1		Receptinis	LT/1/15/3739/009	Netiekiama	-	-	No	-	-
62489	76898	1076898	tūbelė	90 g N1		Receptinis	LT/1/15/3739/010	Netiekiama	-	-	No	-	-
62490	76899	1076899	tūbelė	100 g N1		Receptinis	LT/1/15/3739/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-06-06	Išregistruotas
2015-06-16	Registruotas