Sialanar

Medicinal product

(Invented) name

Sialanar

Active substance (s)

Glikopironis

Strength

320 µg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A03AB02, Glycopyrronium

Marketing authorisation holder

Proveca Pharma Limited, Airija

Date of authorisation

2016-09-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral solution	1 ml
Glikopironis	320 µg

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
66548	81083	1081083	buteliukas	250 ml, geriamasis švirkštas ir švirkšto adapteris N1		Receptinis	EU/1/16/1135/001	Netiekiama	-	-	No	-	-
101445	87548	1087548	buteliukas	60 ml, geriamasis švirkštas ir švirkšto adapteris N1		Receptinis	EU/1/16/1135/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-09-15	Registruotas