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
Chinoin Private Co. Ltd.
- Coaprovel - irbesartan / hydrochlorothiazide
- Karvezide - irbesartan / hydrochlorothiazide
- Irbesartan hydrochlorothiazide bms - irbesartan / hydrochlorothiazide
- Ifirmacombi - irbesartan / hydrochlorothiazide
Prescription drugs listed. Substance: "Irbesartan / hydrochlorothiazide"
Sanofi Winthrop Industrie
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
The PSUR cycle of Irbesartan Hydrochlorothiazide Zentiva is aligned with the
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan (RMP)