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Emselex (darifenacin hydrobromide) – Conditions or restrictions regarding supply and use - G04BD10

Updated on site: 06-Oct-2017

Medication nameEmselex
ATC CodeG04BD10
Substancedarifenacin hydrobromide
ManufacturerMerus Labs Luxco S.à R.L.

A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Merus Labs Netherlands B.V.,

Alexander Battalaan 37

6221 CB Maastricht

The Netherlands

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 REGARDING THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Not applicable.

OTHER CONDITIONS

PSURs

The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.

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