Kirsty [Kixelle]

Medicinal product

(Invented) name

Kirsty [Kixelle]

Active substance (s)

Insulinas aspartas

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)

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 pre-filled pen	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
106032	92133	1092133	užpildytas švirkštiklis	3 ml N1		Receptinis	EU/1/20/1506/004	Netiekiama	-	-	No	-	-
106033	92134	1092134	užpildytas švirkštiklis	3 ml N5		Receptinis	EU/1/20/1506/005	Netiekiama	-	-	No	-	-
106034	92135	1092135	užpildytas švirkštiklis	3 ml N10		Receptinis	EU/1/20/1506/006	Netiekiama	-	-	No	-	-
106035	92136	1092136	užpildytas švirkštiklis	3 ml N10 (2x5)		Receptinis	EU/1/20/1506/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-05	Registruotas