Rapamune

Medicinal product

(Invented) name

Rapamune

Active substance (s)

Sirolimuzas

Strength

1 mg/ml

Pharmaceutical form

geriamasis tirpalas

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

2001-03-13

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

Oral solution	1 ml
Sirolimuzas	1 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
1831	7508	1007508	buteliukas	60 ml N1 (+ 30 švirkštų, švirkšto adapteris ir švirkšto dėklas)		Receptinis	EU/1/01/171/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-03-13	Registruotas