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

Updated on site: 10-Oct-2017

Medication nameTelmisartan Actavis
ATC CodeC09CA07
Substancetelmisartan
ManufacturerActavis Group PTC ehf

A.MANUFACTUER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Actavis hf

Reykjavíkurvegur 76-78, IS-220 Hafnarfjördur

Iceland

Actavis Ltd

BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000

Malta

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 AUTHORIZATION

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.

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

Not applicable.

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