Genotropin

Medicinal product

(Invented) name

Genotropin

Active substance (s)

Somatropinas

Strength

5,3 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

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

Pfizer Europe MA EEIG, Belgija

Date of authorisation

1999-06-04

Date of renewal

2008-07-03

Documents

1195 Genotropin II PL 2025 04 15.docx

1195 Pakuotės lapelis 2025 04 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml paruošto tirpalo yra	1 ml
Somatropinas	5,3 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
10747	2893	1002893	užtaisas	N1		Receptinis	LT/1/99/1195/001	Netiekiama	-	-	No	-	-
10748	15292	1015292	užtaisas	N5		Receptinis	LT/1/99/1195/002	Netiekiama	-	-	No	-	-
46508	60316	1060316	užpildytas švirkštiklis	N1 (GoQuick)		Receptinis	LT/1/99/1195/005	Tiekiama	-	-	No	-	-
46509	60317	1060317	užpildytas švirkštiklis	N5 (GoQuick)		Receptinis	LT/1/99/1195/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-07-03	Perregistruotas
1999-06-04	Registruotas