Somatropin Biopartners

Medicinal product

(Invented) name

Active substance (s)

Somatropinas

Strength

10 mg

Pharmaceutical form

milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

H01AC01, Somatropin

Marketing authorisation holder

BioPartners GmbH, Vokietija

Date of authorisation

2013-08-05

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for prolonged-release suspension for injection	1 vnt.
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
57041	71153	1071153	flakonas	N1+N1		Receptinis	EU/1/13/849/004	Netiekiama	-	-	No	-	-
57042	71154	1071154	flakonas	N4+N4		Receptinis	EU/1/13/849/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-09	Išregistruotas
2013-08-05	Registruotas