Norditropin SimpleXx

Medicinal product

(Invented) name

Norditropin SimpleXx

Active substance (s)

Somatropinas

Strength

10 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

2005-06-29

Date of renewal

2009-04-24

Documents

0249 Norditropin SimpleXx PCS PL 2021 07 28.docx

0249 Pakuotės lapelis 10mg 2021 07 28.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0001/006/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1,5 ml tirpalo yra	1.5 ml
Somatropinas	10 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
13805	4103	1004103	užtaisas	1,5 ml N1		Receptinis	LT/1/05/0249/001	Netiekiama	-	-	No	-	-	Download
13806	18082	1018082	užtaisas	1,5 ml N3		Receptinis	LT/1/05/0249/002	Netiekiama	-	-	No	-	-
13807	18083	1018083	užtaisas	1,5 ml N5		Receptinis	LT/1/05/0249/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-30	Išregistruotas
2009-04-24	Perregistruotas
2005-06-29	Registruotas