Omnitrope

Medicinal product

(Invented) name

Omnitrope

Active substance (s)

Somatropinas

Strength

15 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

2011-06-16

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	15 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
47532	61349	1061349	užtaisas	N1 (SurePal 15)		Receptinis	EU/1/06/332/010	Netiekiama	-	-	No	-	-
47533	61350	1061350	užtaisas	N5 (SurePal 15)		Receptinis	EU/1/06/332/011	Netiekiama	-	-	No	-	-
47534	61351	1061351	užtaisas	N10 (SurePal 15)		Receptinis	EU/1/06/332/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-06-16	Registruotas