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Wilzin (zinc) – Conditions or restrictions regarding supply and use - A16AX05

Updated on site: 10-Oct-2017

Medication nameWilzin
ATC CodeA16AX05
Substancezinc
ManufacturerOrphan Europe S.A.R.L.

Article Contents

AMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Orphan Europe SARL

Immeuble "Le Wilson"

70, avenue du Général de Gaulle F-92800 Puteaux

France

or

Orphan Europe SARL Eco River Parc

30, rue des Peupliers F-92000 Nanterre France

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 restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)

OTHER CONDITIONS

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

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