Seroquel XR 300 mg tablete s produljenim oslobađanjem
| Name | Seroquel XR 300 mg tablete s produljenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-408184728 |
| Active Substance | kvetiapinfumarat |
| Composition | jedna tableta s produljenim oslobađanjem sadrži 300 mg kvetiapina (u obliku kvetiapinfumarata) |
| Pharmaceutical Form | tableta s produljenim oslobađanjem |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru, u kutiji [HR-H-408184728-01] 30 tableta u blisteru, u kutiji [HR-H-408184728-02] 50 tableta u blisteru, u kutiji [HR-H-408184728-03] 60 tableta u blisteru, u kutiji [HR-H-408184728-04] 100 tableta u blisteru, u kutiji [HR-H-408184728-05] |
| Manufacturer | AstraZeneca UK Limited, Macclesfield, Cheshire, Ujedinjeno Kraljevstvo AstraZeneca AB, Sodertalje, Švedska Cheplapharm Arzneimittel GmbH, Greifswald, Njemačka Klocke Pharma-Service GmbH, Appenweier, Njemačka |
| Marketing Authorisation Holder | AstraZeneca d.o.o., Radnička cesta 80, Zagreb, Hrvatska |
| Marketing Authorisation Date | 20.04.2016 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/15-02/71 |
| Registration Number | 381-12-01/70-16-07 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N05AH04 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Podsjetnik o važnosti nadziranja metaboličkih parametara tijekom liječenja kvetiapinom, verzija 2 |
