Genotropin

Medicinal product

(Invented) name

Genotropin

Active substance (s)

Somatropinas

Strength

12 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

1999-03-05

Date of renewal

2008-07-03

Documents

1195 Pakuotės lapelis 2025 04 15.docx

1195 Genotropin II PL 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	12 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
10542	2620	1002620	užtaisas	N1		Receptinis	LT/1/99/1195/003	Netiekiama	-	-	No	-	-
10543	15108	1015108	užtaisas	N5		Receptinis	LT/1/99/1195/004	Netiekiama	-	-	No	-	-
46510	60318	1060318	užpildytas švirkštiklis	N1 (GoQuick)		Receptinis	LT/1/99/1195/007	Tiekiama	-	-	No	-	-
46511	60319	1060319	užpildytas švirkštiklis	N5 (GoQuick)		Receptinis	LT/1/99/1195/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-07-03	Perregistruotas
1999-03-05	Registruotas