A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers responsible for batch release
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
TEVA UK Ltd
Brampton Road, Hampden Park
Eastbourne, East Sussex,
2031 GA Haarlem
Teva Czech Industries s.r.o. Ostravska 29/305
Teva Operations Poland Sp.z.o.o ul. Mogilska 80
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
Ibandronic Acid Teva 50 mg: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Ibandronic Acid Teva 150 mg: Medicinal product 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)