Omnitrope

Medicinal product

(Invented) name

Omnitrope

Active substance (s)

Somatropinas

Strength

10 mg/1,5 ml

Pharmaceutical form

injekcinis tirpalas

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

2007-09-19

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

Solution for injection	1.5 ml
Somatropinas	10 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
27755	30297	1030297	užtaisas	N1		Receptinis	EU/1/06/332/007	Netiekiama	-	-	No	-	-
27756	30298	1030298	užtaisas	N5		Receptinis	EU/1/06/332/008	Netiekiama	-	-	No	-	-
27757	30299	1030299	užtaisas	N10		Receptinis	EU/1/06/332/009	Netiekiama	-	-	No	-	-
59609	73840	1073840	užtaisas	N1 (SurePal 10)		Receptinis	EU/1/06/332/016	Tiekiama	-	-	No	-	-
59610	73841	1073841	užtaisas	N5 (SurePal 10)		Receptinis	EU/1/06/332/017	Netiekiama	-	-	No	-	-
59611	73842	1073842	užtaisas	N10 (SurePal 10)		Receptinis	EU/1/06/332/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-09-19	Registruotas