AMGLIDIA

Medicinal product

(Invented) name

AMGLIDIA

Active substance (s)

Glibenklamidas

Strength

6 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10BB01, Glibenclamide

Marketing authorisation holder

AMMTeK, Prancūzija

Date of authorisation

2018-05-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral suspension	1 ml
Glibenklamidas	6 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
99656	85763	1085763	buteliukas	30 ml, švirkšto adapteris ir geriamasis švirkštas (1 ml) N1		Receptinis	EU/1/18/1279/003	Netiekiama	-	-	No	-	-
99657	85764	1085764	buteliukas	30 ml, švirkšto adapteris ir geriamasis švirkštas (5 ml) N1		Receptinis	EU/1/18/1279/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-24	Registruotas