Omnitrope

Medicinal product

(Invented) name

Omnitrope

Active substance (s)

Somatropinas

Strength

5 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

2006-04-12

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	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
27747	30289	1030289	užtaisas	N1		Receptinis	EU/1/06/332/004	Netiekiama	-	-	No	-	-
27748	30290	1030290	užtaisas	N5		Receptinis	EU/1/06/332/005	Netiekiama	-	-	No	-	-
27749	30291	1030291	užtaisas	N10		Receptinis	EU/1/06/332/006	Netiekiama	-	-	No	-	-
59612	73843	1073843	užtaisas	N1 (SurePal 5)		Receptinis	EU/1/06/332/013	Netiekiama	-	-	No	-	-
59613	73844	1073844	užtaisas	N5 (SurePal 5)		Receptinis	EU/1/06/332/014	Tiekiama	-	-	No	-	-
59614	73845	1073845	užtaisas	N10 (SurePal 5)		Receptinis	EU/1/06/332/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-04-12	Registruotas