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Evista (raloxifene hydrochloride) – Conditions or restrictions regarding supply and use - G03XC01

Updated on site: 06-Oct-2017

Medication nameEvista
ATC CodeG03XC01
Substanceraloxifene hydrochloride
ManufacturerDaiichi Sankyo Europe GmbH

A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Lilly SA

Avda de la Industria 30 28108 Alcobendas Madrid

Spain

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

B.CONDITIONS OF THE MARKETING AUTHORISATION

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER

Medicinal product subject to medical prescription

CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Not applicable.

OTHER CONDITIONS

-The Marketing Authorisation Holder will provide the PSUR at 3-yearly intervals.

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