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Telmisartan Teva (telmisartan) – Conditions or restrictions regarding supply and use - C09CA07

Updated on site: 10-Oct-2017

Medication nameTelmisartan Teva
ATC CodeC09CA07
Substancetelmisartan
ManufacturerTeva B.V.

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

TEVA Pharmaceutical Works Private Limited Company

HU-4042 Debrecen

Pallagi út 13

Hungary

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllő

Táncsics Mihály út 82

Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne

East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem,

The Netherlands

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.

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.

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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