A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
TEVA UK Ltd
Eastbourne, East Sussex
BN22 9AG UK
2031 GA Haarlem
Teva Operations Poland Sp.z o. o. Mogilska 80 Str.
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 restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Periodic Safety Report
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
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
•Risk Management Plan (RMP)