Medicinal Products

Mispregnol 400 mikrograma tablete

Name Mispregnol 400 mikrograma tablete
Marketing Authorisation Number HR-H-148237306
Active Substance misoprostolum
Pharmaceutical Form tableta
Strength 400 mikrograma
Packaging [MA Number for Packaging] 1 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-148237306-01]
4 tablete u blisteru s jediničnom dozom, u kutiji  [HR-H-148237306-02]
16 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-148237306-03]
40 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-148237306-04]
Manufacturer Laboratoires MACORS, Auxerre, Francuska;
Delpharm Lille S.A.S., Lys Lez Lannoy, Francuska;
Nordic Pharma B.V., LM Baarn, Nizozemska
Marketing Authorisation Holder Nordic Group B.V., Siriusdreef 22, Hoofddorp, Nizozemska
Marketing Authorisation Date 17.08.2018
MA Period of Validity unlimited
Classification Number UP/I-530-09/16-02/307
Registration Number 381-12-01/70-18-07
Composition jedna tableta sadrži 400 mikrograma mizoprostola
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code G02AD06
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Vodič za zdravstvene radnike, verzija 1
Educational materials
for patients / caregivers
Brošura za korisnice lijeka, verzija 1
Kartica s upozorenjima, verzija 1
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