A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
11 Ion Mihalache Blvd.
- Rapilysin - Actavis Group PTC ehf
- Zoledronic acid actavis - Actavis Group PTC ehf
- Armisarte (pemetrexed actavis) - Actavis Group PTC ehf
- Nemdatine - Actavis Group PTC ehf.
- Topotecan actavis - Actavis Group PTC ehf
- Ebilfumin - Actavis Group PTC ehf
Prescription drugs listed. Manufacturer: "Actavis Group PTC ehf"
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 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)