Dormicum

Medicinal product

(Invented) name

Dormicum

Active substance (s)

Midazolamas

Strength

7,5 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

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_1 Dormicum tab PCS PL keit.docx

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Midazolamas	7,5 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
17352	21245	1021245	lizdinė plokštelė	N10		Receptinis	LT/1/94/0506/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2017-11-10	Išregistruotas
2010-06-15	Perregistruotas
1994-06-22	Registruotas