ZOMACTON

Medicinal product

(Invented) name

ZOMACTON

Active substance (s)

Somatropinas

Strength

4 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

Ferring GmbH, Vokietija

Date of authorisation

1996-12-06

Date of renewal

2009-10-14

Documents

1706_1_ZOMACTON_4mg_inj_tirpalui_RPP_200122.docx

1706_1_2_Pakuotės lapelis_200122.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Viename buteliuke yra	1 vnt.
Somatropinas	4 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
2720	8286	1008286	flakonas	flakonas miltelių ir ampulė tirpiklio N1		Receptinis	LT/1/96/1706/001	Netiekiama	-	-	No	-	-	Download
2721	8287	1008287	flakonas	flakonas miltelių, ampulė tirpiklio, adapteris, švirkštas ir adata N5		Receptinis	LT/1/96/1706/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-01	Išregistruotas
2009-10-14	Perregistruotas
1996-12-06	Registruotas