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Irbesartan Hydrochlorothiazide Zentiva (Irbesartan Hydrochlorothiazide Winthrop) (irbesartan / hydrochlorothiazide) – Conditions or restrictions regarding supply and use - C09DA04

Updated on site: 08-Oct-2017

Medication nameIrbesartan Hydrochlorothiazide Zentiva (Irbesartan Hydrochlorothiazide Winthrop)
ATC CodeC09DA04
Substanceirbesartan / hydrochlorothiazide
Manufacturersanofi-aventis groupe  

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave

F-33565 Carbon Blanc Cedex France

Chinoin Private Co. Ltd.

Lévai u.5.

2112 Veresegyhaz

Hungary

Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel 37100 Tours

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 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 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.

PSUR

The PSUR cycle of Irbesartan Hydrochlorothiazide Zentiva is aligned with the cross-referred product, COAPROVEL, until otherwise specified.

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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