Medicinal Products

Metotreksat Cipla 2,5 mg tablete

Name Metotreksat Cipla 2,5 mg tablete
Marketing Authorisation Number HR-H-906574672
Active Substance methotrexatum
Pharmaceutical Form tableta
Strength 2,5 mg
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 (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-530-09/19-02/74
Registration Number 381-12-01/30-19-03
Composition svaka tableta sadrži 2,5 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 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
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