Rapamune

Medicinal product

(Invented) name

Rapamune

Active substance (s)

Sirolimuzas

Strength

0,5 mg

Pharmaceutical form

dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

L04AH01, Sirolimus

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2001-03-14

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

Coated tablet	1 vnt.
Sirolimuzas	0,5 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
42309	56075	1056075	lizdinė plokštelė	N30		Receptinis	EU/1/01/171/013	Netiekiama	-	-	No	-	-
42310	56076	1056076	lizdinė plokštelė	N100		Receptinis	EU/1/01/171/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-03-14	Registruotas