Humulin N KwikPen

Medicinal product

(Invented) name

Humulin N KwikPen

Active substance (s)

Insulinas, žmogaus

Strength

100 TV/ml

Pharmaceutical form

injekcinė suspensija užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AC01, Insulin (human)

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2018-01-24

Date of renewal

2019-05-27

Documents

4184_6-8_Humulin N KwikPen_inj_susp_RPP_200908.docx

4184_6-8_Pakuotės lapelis_200908.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0645/008

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml suspensijos yra	1 ml
Insulinas, žmogaus	100 TV

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
62442	76850	1076850	užpildytas švirkštiklis	3 ml N5		Receptinis	LT/1/18/4184/006	Tiekiama	-	-	No	-	-
98783	84887	1084887	užpildytas švirkštiklis	3 ml N6		Receptinis	LT/1/18/4184/007	Netiekiama	-	-	No	-	-
98784	84888	1084888	užpildytas švirkštiklis	3 ml N10 (2x5)		Receptinis	LT/1/18/4184/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-27	Perregistruotas
2018-01-24	Registruotas