Norditropin FlexPro

Medicinal product

(Invented) name

Norditropin FlexPro

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

2010-11-24

Date of renewal

2015-08-06

Documents

2240_1_4 Norditropin FlexPro inj svirkstiklyje RPP 200221.docx

2240_1_2 Pakuotės lapelis 200221.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0001/014/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra 3,3 mg somatropino	1 vnt.
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
34847	37188	1037188	užpildytas švirkštiklis	N1		Receptinis	LT/1/10/2240/001	Netiekiama	-	-	No	-	-
43947	57733	1057733	užpildytas švirkštiklis	N5		Receptinis	LT/1/10/2240/002	Netiekiama	-	-	No	-	-

Stadijos

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