Norditropin SimpleXx

Medicinal product

(Invented) name

Norditropin SimpleXx

Active substance (s)

Somatropinas

Strength

5 mg/1,5 ml

Pharmaceutical form

injekcinis tirpalas

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

2005-09-29

Date of renewal

2009-04-24

Documents

0249 Pakuotės lapelis 5mg 2021 07 28.docx

0249 Norditropin SimpleXx PCS PL 2021 07 28.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0001/005/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1,5 ml tirpalo yra	1.5 ml
Somatropinas	5 mg

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
15630	19767	1019767	užtaisas	1,5 ml N1		Receptinis	LT/1/05/0249/004	Netiekiama	-	-	No	-	-
15631	19768	1019768	užtaisas	1,5 ml N3		Receptinis	LT/1/05/0249/005	Netiekiama	-	-	No	-	-
15632	19769	1019769	užtaisas	1,5 ml N5		Receptinis	LT/1/05/0249/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-30	Išregistruotas
2009-04-24	Perregistruotas
2005-09-29	Registruotas