Kirsty [Kixelle]

Medicinal product

(Invented) name

Kirsty [Kixelle]

Active substance (s)

Insulinas aspartas

Strength

100 V/ml

Pharmaceutical form

injekcinis tirpalas flakone

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AB05, Insulin aspart

Marketing authorisation holder

Biosimilar Collaborations Ireland Limited, Airija

Date of authorisation

2021-02-05

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 vial	1 ml
Insulinas aspartas	100 V

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
106036	92137	1092137	flakonas	10 ml N1		Receptinis	EU/1/20/1506/001	Netiekiama	-	-	No	-	-
106037	92138	1092138	flakonas	10 ml N5		Receptinis	EU/1/20/1506/002	Netiekiama	-	-	No	-	-
106038	92139	1092139	flakonas	10 ml N5 (1x10 ml)		Receptinis	EU/1/20/1506/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-05	Registruotas