Hycamtin

Medicinal product

(Invented) name

Hycamtin

Active substance (s)

Topotekanas

Strength

0,25 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01CE01, topotecan

Marketing authorisation holder

Sandoz Pharmaceuticals d.d., Slovėnija

Date of authorisation

2008-03-18

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

Capsule, hard	1 vnt.
Topotekanas	0,25 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
29305	4910	1004910	lizdinė plokštelė	N10		Receptinis	EU/1/96/027/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-03-18	Registruotas