Myleran

Medicinal product

(Invented) name

Myleran

Active substance (s)

Busulfanas

Strength

2 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AB01, Busulfan

Marketing authorisation holder

Aspen Pharma Trading Limited, Airija

Date of authorisation

1994-11-11

Date of renewal

2011-04-29

Documents

2445 Myleran RPP 2023 05 15.docx

2445 Pakuotės lapelis 2023 05 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Busulfanas	2 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
1125	1323	1001323	buteliukas	N100		Receptinis	LT/1/94/2445/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2011-04-29	Perregistruotas
1994-11-11	Registruotas