Signifor

Medicinal product

(Invented) name

Signifor

Active substance (s)

Pazireotidas

Strength

40 mg

Pharmaceutical form

milteliai ir tirpiklis injekcinei suspensijai

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01CB05, Pasireotide

Marketing authorisation holder

Recordati Rare Diseases, Prancūzija

Date of authorisation

2012-04-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for suspension for injection	1 vnt.
Pazireotidas	40 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
61813	76183	1076183	flakonas	milteliai, tirpiklio užpildytas švirkštas (2 ml), saugi adata ir flakono adapteris N1		Receptinis	EU/1/12/753/014	Tiekiama	-	-	No	-	-
61814	76184	1076184	flakonas	milteliai, tirpiklio užpildytas švirkštas (2 ml), saugi adata ir flakono adapteris N1x3 (daugiadozė)		Receptinis	EU/1/12/753/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-04-24	Registruotas