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Entacapone Teva (entacapone) – Conditions or restrictions regarding supply and use - N04BX02

Updated on site: 06-Oct-2017

Medication nameEntacapone Teva
ATC CodeN04BX02
Substanceentacapone
ManufacturerTeva Pharma B.V.

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 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

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

Teva Operations Poland Sp.z.o.o. ul. Mogilska 80, 31-546, Krakow Poland

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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