Buccolam

Medicinal product

(Invented) name

Buccolam

Active substance (s)

Midazolamas

Strength

10 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	2 ml
Midazolamas	10 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
49765	63636	1063636	užpildytas švirkštas	2 ml N4		Receptinis	EU/1/11/709/004	Netiekiama	-	-	No	-	-
107733	93838	1093838	užpildytas švirkštas	2 ml N2		Receptinis	EU/1/11/709/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-09-05	Registruotas