Cerezyme

Medicinal product

(Invented) name

Cerezyme

Active substance (s)

Imigliucerazė

Strength

400 V

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB02, Imiglucerase

Marketing authorisation holder

Sanofi B.V., Nyderlandai

Date of authorisation

1997-11-17

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 for concentrate for solution for infusion	1 vnt.
Imigliucerazė	400 V

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
1220	7026	1007026	flakonas	N1		Receptinis	EU/1/97/053/003	Tiekiama	-	-	No	-	-
25465	28072	1028072	flakonas	N5		Receptinis	EU/1/97/053/004	Netiekiama	-	-	No	-	-
25466	28073	1028073	flakonas	N25		Receptinis	EU/1/97/053/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1997-11-17	Registruotas