Midermin

Medicinal product

(Invented) name

Midermin

Active substance (s)

Mometazono furoatas

Strength

1 mg/g

Pharmaceutical form

odos tirpalas

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

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2013-02-19

Date of renewal

Documents

3220_1_4 Midermin odos tirp PL keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PT/H/0726/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g tirpalo 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
47813	61635	1061635	buteliukas	20 ml N1		Receptinis	LT/1/13/3220/001	Netiekiama	-	-	No	-	-
55255	69302	1069302	buteliukas	30 ml N1		Receptinis	LT/1/13/3220/002	Netiekiama	-	-	No	-	-
55256	69303	1069303	buteliukas	50 ml N1		Receptinis	LT/1/13/3220/003	Netiekiama	-	-	No	-	-
55257	69304	1069304	buteliukas	60 ml N1		Receptinis	LT/1/13/3220/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-04	Išregistruotas
2013-02-19	Registruotas