Mizormic

Medicinal product

(Invented) name

Mizormic

Active substance (s)

Midazolamas

Strength

5 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, vartoti į tiesiąją žarną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05CD08, Midazolam

Marketing authorisation holder

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2012-04-23

Date of renewal

2017-06-07

Documents

2898_1-6_Mizormic_inj_inf_tirp_RPP_181109.docx

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Midazolamas	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
45725	59527	1059527	ampulė	1 ml N5		Receptinis	LT/1/12/2898/001	Netiekiama	-	-	No	-	-
45726	59528	1059528	ampulė	1 ml N10		Receptinis	LT/1/12/2898/002	Netiekiama	-	-	No	-	-
45727	59529	1059529	ampulė	3 ml N5		Receptinis	LT/1/12/2898/003	Netiekiama	-	-	No	-	-
52153	66071	1066071	ampulė	3 ml N10		Receptinis	LT/1/12/2898/004	Netiekiama	-	-	No	-	-
52154	66072	1066072	ampulė	10 ml N5		Receptinis	LT/1/12/2898/005	Netiekiama	-	-	No	-	-
52155	66073	1066073	ampulė	10 ml N10		Receptinis	LT/1/12/2898/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-05	Išregistruotas
2017-06-07	Perregistruotas
2012-04-23	Registruotas