Norditropin FlexPro

Medicinal product

(Invented) name

Norditropin FlexPro

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

2010-11-24

Date of renewal

2015-08-06

Documents

2240_1_4 Norditropin FlexPro inj svirkstiklyje RPP 200221.docx

2240_3_4 Pakuotės lapelis 200221.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0001/015/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra 6,7 mg somatropino	1 vnt.
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
34848	37189	1037189	užpildytas švirkštiklis	1,5 ml N1		Receptinis	LT/1/10/2240/003	Netiekiama	-	-	No	-	-
43948	57734	1057734	užpildytas švirkštiklis	1,5 ml N5		Receptinis	LT/1/10/2240/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-29	Išregistruotas
2015-08-06	Perregistruotas
2010-11-24	Registruotas