A.MANUFACTUER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) responsible for batch release
BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000
- Rapilysin - Actavis Group PTC ehf
- Sildenafil actavis - Actavis Group PTC ehf
- Levetiracetam actavis group - Actavis Group PTC ehf
- Potactasol - Actavis Group PTC ehf
- Zoledronic acid actavis - Actavis Group PTC ehf
- Ebilfumin - Actavis Group PTC ehf
Prescription drugs listed. Manufacturer: "Actavis Group PTC ehf"
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 medical prescription.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION
- Telmisartan teva pharma - C09CA07
- Tolura - C09CA07
- Telmisartan teva - C09CA07
- Kinzalmono (telmisartan boehringer ingelheim pharma kg) - C09CA07
- Micardis - C09CA07
Prescription drugs listed. ATC Code: "C09CA07"
Periodic Safety Update Reports
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