Norditropin NordiFlex

Medicinal product

(Invented) name

Norditropin NordiFlex

Active substance (s)

Somatropinas

Strength

10 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

4653_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/0001/012/E/007

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Somatropinas	10 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
105522	91622	1091622	užpildytas švirkštiklis	1,5 ml N1		Receptinis	LT/1/20/4653/001	Netiekiama	-	-	No	-	-
105523	91623	1091623	užpildytas švirkštiklis	1,5 ml N5		Receptinis	LT/1/20/4653/002	Netiekiama	-	-	No	-	-
105524	91624	1091624	užpildytas švirkštiklis	1,5 ml N10		Receptinis	LT/1/20/4653/003	Netiekiama	-	-	No	-	-

Stadijos

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