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Actelsar HCT (telmisartan / hydrochlorothiazide) – Conditions or restrictions regarding supply and use - C09DA07

Updated on site: 11-Jul-2017

Medication nameActelsar HCT
ATC CodeC09DA07
Substancetelmisartan / hydrochlorothiazide
ManufacturerActavis Group hf

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

Actavis hf. Reykjavikurvegur 78 220 Hafnarfjörður 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 prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic safety update reports

At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product. However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included 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

Risk Management Plan (RMP)

Not applicable.

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