Norditropin NordiFlex

Medicinal product

(Invented) name

Norditropin NordiFlex

Active substance (s)

Somatropinas

Strength

5 mg/1,5 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)

H01AC01, Somatropin

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2020-12-22

Date of renewal

2024-11-21

Documents

4652_pakuotes lapelis_2024-11-21.docx

4652-53_Norditropin_Nordiflex_perr2024-11-21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0001/011/E/007

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Somatropinas	5 mg/1,5 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
105519	91619	1091619	užpildytas švirkštiklis	1,5 ml N1		Receptinis	LT/1/20/4652/001	Netiekiama	-	-	No	-	-
105520	91620	1091620	užpildytas švirkštiklis	1,5 ml N5		Receptinis	LT/1/20/4652/002	Netiekiama	-	-	No	-	-
105521	91621	1091621	užpildytas švirkštiklis	1,5 ml N10		Receptinis	LT/1/20/4652/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-21	Perregistruotas
2020-12-22	Registruotas