Myfortic 180 mg želučanootporne tablete
| Name | Myfortic 180 mg želučanootporne tablete |
|---|---|
| Marketing Authorisation Number | HR-H-505070647 |
| Active Substance | mikofenolatnatrij |
| Composition | jedna želučanootporna tableta sadrži 180 mg mikofenolatne kiseline u obliku natrijevog mikofenolata |
| Pharmaceutical Form | želučanootporna tableta |
| Manufacturer | Novartis Pharma GmbH, Nürnberg, Njemačka Lek Pharmaceuticals d.d., Lendava, Slovenija Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenija Novartis Farmacéutica S.A., Barcelona, Španjolska |
| Marketing Authorisation Holder | Novartis Hrvatska d.o.o., Radnička cesta 37b, Zagreb, Hrvatska |
| Marketing Authorisation Date | 19.10.2015 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/381 |
| Registration Number | 381-12-01/70-15-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L04AA06 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Educational materials for healthcare professionals |
Upitnik za zdravstvene radnike, verzija 1 Obrazac za prijavu i praćenje trudnoće za zdravstvene radnike, verzija 1 Vodič za zdravstvene radnike, verzija 2 |
| Educational materials for patients / caregivers |
Upitnik za bolesnike, verzija 1 Vodič za bolesnike, verzija 2 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o izmijenjenim preporukama za kontracepciju povezanim s primjenom mofetilmikofenolata/mikofenolatne kiseline (CellCept, Myfortic, Trixin) | 22.01.2018 | Roche d.o.o., Novartis Hrvatska d.o.o., Pliva Hrvatska d.o.o. |
