Humulin R

Medicinal product

(Invented) name

Humulin R

Active substance (s)

Insulinas, žmogaus

Strength

100 TV/ml

Pharmaceutical form

injekcinis tirpalas užtaise

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AB01, 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 Humulin R PCS 2023 11 16.docx

4184_11_12_Pakuotės lapelis_200908.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0645/004

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml injekcinio tirpalo 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
62439	76847	1076847	užtaisas	3 ml N5		Receptinis	LT/1/18/4184/011	Tiekiama	-	-	No	-	-
98786	84890	1084890	užtaisas	3 ml N10		Receptinis	LT/1/18/4184/012	Netiekiama	-	-	No	-	-

Stadijos

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