ZOMACTON

Medicinal product

(Invented) name

ZOMACTON

Active substance (s)

Somatropinas

Strength

10 mg/ml

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

H01AC01, Somatropin

Marketing authorisation holder

Ferring GmbH, Vokietija

Date of authorisation

2009-10-14

Date of renewal

2014-10-16

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Miltelių flakone yra:	1 ml
Somatropinas	10 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
27383	29938	1029938	flakonas	milteliai, užpildytas švirkštas tirpiklio N1	Receptinis	LT/1/96/1706/003	Netiekiama	-	-	No	-	-
29098	31606	1031606	flakonas	milteliai, užpildytas švirkštas tirpiklio N3	Receptinis	LT/1/96/1706/004	Netiekiama	-	-	No	-	-
37248	50869	1050869	flakonas	milteliai, užpildytas švirkštas tirpiklio N5	Receptinis	LT/1/96/1706/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-10-16	Perregistruotas
2009-10-14	Registruotas