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Tekturna (aliskiren) – Conditions or restrictions regarding supply and use - C09XA02

Updated on site: 10-Oct-2017

Medication nameTekturna
ATC CodeC09XA02
Substancealiskiren
ManufacturerNovartis Europharm Ltd.
Not applicable.

A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Novartis Farma S.p.A.

Via Provinciale Schito 131

I-80058 Torre Annunziata/NA

Italy

B.

CONDITIONS OF THE MARKETING AUTHORISATION

 

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON

 

THE MARKETING AUTHORISATION HOLDER

authorised

Medicinal product subject to medical prescription.

 

 

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

OTHER CONDITIONS

Pharmacovigilance systemlonger

The MAH must ensure that the system of pharmacovigi ance, as described in version 2 (dated

5 July 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.

Risk Management Plan

product

no

 

The MAH commits to performing the st dies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 30 May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.

As per the CHMP Guide ine on Risk Management Systems for medicinal products for human use, the updated RMP shou d be submitted at the same time as the next Periodic Safety Update Report (PSUR).

In addition, an updated RMP should be submitted

When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities.

Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being r ached.

At the request of the EMEA.Medicinal

Comments

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