Buccolam

Medicinal product

(Invented) name

Buccolam

Active substance (s)

Midazolamas

Strength

5 mg

Pharmaceutical form

burnos gleivinės tirpalas

Route (s) of administration

vartoti ant burnos gleivinės

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05CD08, Midazolam

Marketing authorisation holder

Neuraxpharm Pharmaceuticals, S.L., Ispanija

Date of authorisation

2011-09-05

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oromucosal solution	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
49763	63634	1063634	užpildytas švirkštas	1 ml N4		Receptinis	EU/1/11/709/002	Netiekiama	-	-	No	-	-
107731	93836	1093836	užpildytas švirkštas	1 ml N2		Receptinis	EU/1/11/709/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-09-05	Registruotas