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Zyllt (clopidogrel hydrogen sulphate) – Conditions or restrictions regarding supply and use - B01AC04

Updated on site: 11-Oct-2017

Medication nameZyllt
ATC CodeB01AC04
Substanceclopidogrel hydrogen sulphate
ManufacturerKrka, d.d., Novo mesto

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

KRKA, d.d., Novo mesto Šmarješka cesta 6

8501 Novo mesto Slovenia

KRKA-POLSKA Sp. z o.o. ul. Równoległa 5

02-235 Warszawa Poland

KRKA - FARMA d.o.o. V. Holjevca 20/E 10450 Jastrebarsko Croatia

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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