Details

Product Name in the RMS: Pragiola 25 mg capsules, hard

MR Number: SI/H/0154/001
Date of outcome: 25.03.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Generic Chemical Substance Prescription Only
Active Substances	pregabalin 25 mg
Form	Capsule, hard
MA Holder in the RMS	Krka, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia
RMS	Slovenia
Date of last change	17.11.2018
ATC-Code	N03AX16 Pregabalin

CMS Country	Domestic Product Name
Bulgaria	Pregabia
Croatia	Pragiola 25 mg tvrde kapsule
Cyprus
Czech Republic	Pragiola 25 mg
Estonia	PRAGIOLA
Greece	PRAGIOLA
Hungary	Pragiola 25 mg kemény kapszula
Latvia	Pragiola 25 mg cietās kapsulas
Lithuania	Pragiola 25 mg kietosios kapsulės
Malta
Poland
Romania	Pragiola
Slovak Republic

Documents
Finalised Product Information:	SI_H_0154_001_FinalPI.pdf (12.10.2018)