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DuoResp Spiromax (budesonide / formoterol fumarate dihydrate) – Conditions or restrictions regarding supply and use - R03AK07

Updated on site: 06-Oct-2017

Medication nameDuoResp Spiromax
ATC CodeR03AK07
Substancebudesonide / formoterol fumarate dihydrate
ManufacturerTeva Pharma B.V.

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

Unit 27/35 IDA Industrial Park

Cork Road

Waterford

Republic of Ireland

Teva Pharmaceuticals Europe B.V.

Swensweg 5

NL-2031 GA Haarlem

The Netherlands

(For Poland only)

Teva Operations Poland Sp. z o.o. Mogilska 80 Str. 31-546 Kraków Poland

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 products subject to medical prescription.

C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic safety update reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates 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)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

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