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Desloratadine Teva (desloratadine) – Conditions or restrictions regarding supply and use - R06AX27

Updated on site: 06-Oct-2017

Medication nameDesloratadine Teva
ATC CodeR06AX27
Substancedesloratadine
ManufacturerTeva B.V

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

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

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13

HU-4042 Debrecen

Hungary

TEVA UK Ltd.

Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

Merckle GmbH

Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren

Germany

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 AND REQUIREMENTS OF THE MARKETING AUTHORISATION

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.

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