Kroatia - kroatisk - HALMED (Agencija za lijekove i medicinske proizvode)

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - imatinibum - filmom obložena tableta - 400 mg - urbroj: svaka filmom obložena tableta sadrži 478 mg imatinibmesilata što odgovara 400 mg imatiniba

Den europeiske union - latvisk - EMA (European Medicines Agency)

actavis group ptc ehf - levetiracetam - epilepsija - antiepileptics, - levetiracetam actavis group ir indicēts kā monoterapija daļējas lēkmes lēkmju ārstēšanā ar sekundāru ģeneralizāciju vai bez tās pacientiem no 16 gadu vecuma ar nesen diagnosticētu epilepsiju. levetiracetam actavis group ir norādīts kā adjunctive terapija:ārstēšanā daļēju sākums lēkmju ar vai bez sekundāras vispārināšanas pieaugušajiem, bērniem un zīdaiņiem no 1 mēneša vecuma ar epilepsiju;ārstēšanā myoclonic lēkmes pieaugušajiem un pusaudžiem no 12 gadu vecuma ar nepilngadīgo myoclonic epilepsija;ārstēšanā galvenais ir vispārēja tonizējoša-clonic lēkmes pieaugušajiem un pusaudžiem no 12 gadu vecuma ar ģeneralizēta idiopātiska epilepsija.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - imatinib mesylate - film-coated tablet - 400 milligram(s) - other antineoplastic agents - antineoplastic agents, protein kinase inhibitor - imatinib actavis group is indicated for the treatment of - paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult patients with ph+ cml in blast crisis. - adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement.

Tyskland - tysk - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

actavis group ptc ehf. (8092378) - omeprazol - magensaftresistente hartkapsel - teil 1 - magensaftresistente hartkapsel; omeprazol (22284) 20 milligramm

Tyskland - tysk - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

actavis group ptc ehf. (8092378) - omeprazol - magensaftresistente hartkapsel - teil 1 - magensaftresistente hartkapsel; omeprazol (22284) 10 milligramm

Moldova - rumensk - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

actavis group ptc ehf. - metforminum - comprimate filmate - 850 mg

Moldova - rumensk - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

actavis group ptc ehf. - metforminum - comprimate filmate - 500 mg

Romania - rumensk - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

actavis group ptc ehf. - islanda - bimatoprostum - pic. oft., sol. - 0,1mg/ml - antiglaucomatoase si miotice analogi de prostaglandine

Romania - rumensk - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

actavis group ptc ehf. - islanda - bimatoprostum - pic. oft., sol. - 0,3mg/ml - antiglaucomatoase si miotice analogi de prostaglandine

Italia - italiensk - AIFA (Agenzia Italiana del Farmaco)

actavis group ptc ehf - atorvastatina - atorvastatina