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XAGRID Capsule (2018)

Active ingredients: Anagrelide

Product Name and Form

Xagrid 0.5 mg hard capsules.

Pharmaceutical form

Hard capsule.

An opaque white hard capsule imprinted with S 063.

Qualitative and Quantitative Composition

Each hard capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride).

Excipient(s) with known effect: Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Anagrelide

Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III and suppress expression of transcription factors including GATA-1 and FOG-1 required for megakaryocytopoiesis, ultimately leading to reduced platelet production.

List of excipients

Capsule contents:

Povidone (E1201)
Lactose, anhydrous
Lactose monohydrate
Cellulose, microcrystalline (E460)
Crospovidone
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)

Printing ink:

Shellac
Strong ammonium solution
Potassium hydroxide (E525)
Black iron oxide (E172)

Pack sizes and Marketing

High-density polyethylene (HDPE) bottles with child-resistant closures and desiccant containing 100 capsules.

Marketing authorization holder
Authorization dates

Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland

Date of first authorisation: 16 November 2004
Date of latest renewal: 16 November 2014

Marketing authorization number:

EU/1/04/295/001