Metotreksat Cipla 2,5 mg tablete
| Name | Metotreksat Cipla 2,5 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-906574672 |
| Active Substance | metotreksat |
| Composition | svaka tableta sadrži 2,5 mg metotreksata |
| Pharmaceutical Form | tableta |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru, u kutiji [HR-H-906574672-01] 24 tablete u blisteru, u kutiji [HR-H-906574672-02] 25 tableta u blisteru, u kutiji [HR-H-906574672-03] 28 tableta u blisteru, u kutiji [HR-H-906574672-04] 30 tableta u blisteru, u kutiji [HR-H-906574672-05] 50 tableta u blisteru, u kutiji [HR-H-906574672-06] 100 tableta u blisteru, u kutiji [HR-H-906574672-07] 25 tableta u bočici, u kutiji [HR-H-906574672-08] 100 tableta u bočici, u kutiji [HR-H-906574672-09] |
| Manufacturer | S&D Pharma CZ, spol. s r.o, Pchery (Pharmos a.s. facility), Češka Cipla Europe NV, Antwerpen, Belgija |
| Marketing Authorisation Holder | Cipla Europe NV, De Keyserlei 58-60, Box-19, Antwerpen, Belgija |
| Marketing Authorisation Date | 17.07.2019 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/74 |
| Registration Number | 381-12-01/30-19-03 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L04AX03 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Lista provjere za farmaceute koji izdaju oralne oblike metotreksata, verzija 1 |
| Educational materials for patients / caregivers |
Kartica za bolesnike, verzija 1 |
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o preporukama za sprječavanje potencijalno fatalnih pogrešaka u doziranju metotreksata za liječenje upalnih bolesti | 02.12.2019 | Sandoz d.o.o., Pliva Hrvatska d.o.o., Actavis Group PTC ehf, Cipla Europe NV |
