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Xagrid (anagrelide) – Conditions or restrictions regarding supply and use - L01XX35

Updated on site: 10-Oct-2017

Medication nameXagrid
ATC CodeL01XX35
Substanceanagrelide
ManufacturerShire Pharmaceutical Contracts Limited

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Wasdell Packaging Limited, Units 1, 2, 3, 5, 6, 7 & 8 Euro Way Industrial Estate, Blagrove, Swindon, SN5 8YW, United Kingdom.

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

Not applicable.

E. SPECIFIC OBLIGATION TO COMPLETE

POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES

This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures.

Clinical aspects:

Description

1.Shire will provide an annual update of all published data concerning the efficacy and safety of anagrelide in ET patients as part of the Annual Reassessment.

Due date

Annually, as part of the annual reassessment

Comments

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