Medicinal Products

Metotreksat Cipla 10 mg tablete

Name Metotreksat Cipla 10 mg tablete
Marketing Authorisation Number HR-H-735674783
Active Substance methotrexatum
Pharmaceutical Form tableta
Strength 10 mg
Packaging [MA Number for Packaging] 10 tableta u blisteru, u kutiji  [HR-H-735674783-01]
25 tableta u blisteru, u kutiji  [HR-H-735674783-02]
30 tableta u blisteru, u kutiji  [HR-H-735674783-03]
50 tableta u blisteru, u kutiji  [HR-H-735674783-04]
100 tableta u blisteru, u kutiji  [HR-H-735674783-05]
25 tableta u bočici, u kutiji  [HR-H-735674783-06]
100 tableta u bočici, u kutiji  [HR-H-735674783-07]
Manufacturer S&D Pharma CZ, spol. s r.o, Pchery (Pharmos a.s. facility), Češka
Cipla (EU) Limited, Addlestone, Surrey, Ujedinjeno Kraljevstvo
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-530-09/19-02/75
Registration Number 381-12-01/30-19-02
Composition svaka tableta sadrži 10 mg metotreksata
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 Ne
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
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