Dormicum

Medicinal product

(Invented) name

Dormicum

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

UAB Roche Lietuva, Lietuva

Date of authorisation

1994-06-22

Date of renewal

2010-06-15

Documents

0506_2 Pakuotės lapelis 180327.docx

0506_2 Dormicum_inj_inf PZ PL 180327, rastas 3R_14985.docx

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

8(3)

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
17353	21246	1021246	ampulė	1 ml N10		Receptinis	LT/1/94/0506/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-10-02	Išregistruotas
2010-06-15	Perregistruotas
1994-06-22	Registruotas