Details

Product Name in the RMS: Pragiola 100 mg capsules, hard

MR Number: SI/H/0154/004
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 100 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	23.12.2020
ATC-Code	N03AX16 Pregabalin

CMS Country	Domestic Product Name
Bulgaria	Pragiola
Croatia	Pragiola 100 mg tvrde kapsule
Czech Republic	Pragiola 100 mg
Estonia	PRAGIOLA
Hungary	Pragiola 100 mg kemény kapszula
Latvia	Pragiola 100 mg cietās kapsulas
Lithuania	Pragiola 100 mg kietosios kapsulės
Malta
Poland	Pragiola
Romania	Pragiola 100 mg capsule
Slovak Republic

Documents
Finalised Product Information:	SI_H_0154_004_FinalPI.pdf (10.08.2020)