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Emadine (emedastine) – Conditions or restrictions regarding supply and use - S01GX06

Updated on site: 06-Oct-2017

Medication nameEmadine
ATC CodeS01GX06
Substanceemedastine
ManufacturerNovartis Europharm Limited

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Names and addresses of the manufacturers responsible for batch release

EMADINE 0.5 mg/ml Eye Drops, solution

S.A. Alcon-Couvreur N.V.,

Rijksweg 14,

B-2870 Puurs,

Belgium.

Alcon Cusí, S.A.,

Camil Fabra 58,

08320 El Masnou,

Barcelona,

Spain.

EMADINE 0.5 mg/ml Eye Drops, solution, single-dose container.

S.A. Alcon-Couvreur N.V.,

Rijksweg 14,

B-2870 Puurs,

Belgium.

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 OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription

C.OTHER CONDITIONS OR RESTRICTIONS WITH THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

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

Not applicable.

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