A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland
Unit 27/35 IDA Industrial Park
Republic of Ireland
- Biresp spiromax - budesonide / formoterol fumarate dihydrate
- Vylaer spiromax - budesonide / formoterol fumarate dihydrate
Prescription drugs listed. Substance: "Budesonide / formoterol fumarate dihydrate"
Teva Pharmaceuticals Europe B.V.
(For Poland only)
Teva Operations Poland Sp. z o.o. Mogilska 80 Str.
- Mycophenolate mofetil teva - Teva Pharma B.V.
- Repaglinide teva - Teva Pharma B.V.
- Leflunomide teva - Teva Pharma B.V.
- Pramipexole teva - Teva Pharma B.V.
- Clopidogrel teva (hydrogen sulphate) - Teva Pharma B.V.
- Pioglitazone teva pharma - Teva Pharma B.V.
Prescription drugs listed. Manufacturer: "Teva Pharma B.V."
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
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.