EpiPen 0,3 mg otopina za injekciju u napunjenoj brizgalici
| Name | EpiPen 0,3 mg otopina za injekciju u napunjenoj brizgalici |
|---|---|
| Marketing Authorisation Number | HR-H-299251328 |
| Active Substance | adrenalin (epinefrin) |
| Composition | 1 ml sadrži 1 mg adrenalina (epinefrina). Pojedinačna doza (0,3 ml) sadrži 0,3 mg (300 mikrograma) adrenalina |
| Pharmaceutical Form | otopina za injekciju u napunjenoj brizgalici |
| Manufacturer | Meda Pharma GmbH & Co. KG, Bad Homburg, Njemačka |
| Marketing Authorisation Holder | Viatris Hrvatska d.o.o., Koranska 2, Zagreb, Hrvatska |
| Marketing Authorisation Date | 16.03.2021 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/276 |
| Registration Number | 381-12-01/30-21-04 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C01CA24 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Educational materials for healthcare professionals |
Lista provjere za propisivace, verzija 3 |
| Educational materials for patients / caregivers |
Brosura za bolesnike, verzija 3 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o povlačenju potencijalno zahvaćenih serija lijekova EpiPen 0,3 mg otopina za injekciju i EpiPen Junior 0,15 mg otopina za injekciju (epinefrin) zbog moguće neispravnosti autoinjektora | 14.04.2017 | Medical Intertrade d.o.o. |
