Omnitrope

Medicinal product

(Invented) name

Omnitrope

Active substance (s)

Somatropinas

Strength

5 mg/ml

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

Sandoz GmbH, Austrija

Date of authorisation

2007-04-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	1 ml
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
27750	30292	1030292	flakonas	N1 + užtaisas		Receptinis	EU/1/06/332/002	Netiekiama	-	-	No	-	-
27751	30293	1030293	flakonas	N5 + 5 užtaisai		Receptinis	EU/1/06/332/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-04-20	Registruotas