ABASAGLAR KwikPen

Medicinal product

(Invented) name

ABASAGLAR KwikPen

Active substance (s)

Insulinas glarginas

Strength

100 V/ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AE04, Insulin glargine

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2014-09-09

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled pen	1 ml
Insulinas glarginas	100 V/ml

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
60194	74466	1074466	užpildytas švirkštiklis	3 ml N5		Receptinis	EU/1/14/944/007	Netiekiama	-	-	No	-	-
60195	74467	1074467	užpildytas švirkštiklis	3 ml N10 (2x5)		Receptinis	EU/1/14/944/008	Netiekiama	-	-	No	-	-
65957	80470	1080470	užpildytas švirkštiklis	3 ml N5		Receptinis	EU/1/14/944/012	Tiekiama	-	-	No	-	-
65958	80471	1080471	užpildytas švirkštiklis	3 ml N10 (2x5)		Receptinis	EU/1/14/944/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-09-09	Registruotas