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BUSULFAN Film-coated tablet (2017)

Product Name and Form

Busulfan 2 mg tablets.

Pharmaceutical form

Film coated tablet.

Busulfan 2 mg tablets are white, film-coated, round biconvex tablets engraved “GX EF3” on one side and “M” on the other.

Qualitative and Quantitative Composition

Each 2 mg tablet contains 2 mg of the active substance busulfan.

Excipient with known effect: lactose.

For the full list of excipients, see section 6.1.

List of excipients

Tablet core:

Lactose, anhydrous
Pregelatinised starch
Magnesium stearate

Tablet coating:

Hypromellose
Titanium dioxide
Triacetin

Pack sizes and Marketing

Busulfan tablets are supplied in amber glass bottles with a child resistant closure containing 25 or 100 tablets.

Marketing authorization holder
Authorization dates

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Date of first authorisation: 13 January 1986
Date of latest renewal: 30 June 2003

Marketing authorization number:

PL 39699/0042