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Sabervel (irbesartan) – Conditions or restrictions regarding supply and use - C09CA04

Updated on site: 10-Oct-2017

Medication nameSabervel
ATC CodeC09CA04
Substanceirbesartan
ManufacturerPharmathen S.A.
Rodopi 69300, Greece
Name and address of the manufacturers responsible for batch release
J. Uriach y Compañía, S.A. Av. Camí Reial, 51-57
ES-08184Palau-solità i Plegamans Barcelona
Spain
Pharmathen S.A. 6 Dervenakion str. 15351 Pallini Attiki Greece
Pharmathen International S.A. Industrial Park Sapes,
Rodopi Prefecture, Block No 5,

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

 

longer

The printed package leaflet of the medicinal product must state the name

manufacturer responsible for the release of the concerned batch.

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY

no

 

Medicinal product subject to medical prescription.

 

authorised and address of the

AND USE

C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Pharmacovigilance systemproduct

The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the MedicinalMarketing Authoris tion is in place and functioning before and whilst the medicinal product is on the market.

Risk Management Plan (RMP)

Not applicable

PSURs

The PSUR submission schedule should follow the PSUR submission schedule for the reference medicinal product.

• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Not applicable.

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