FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Enzepi 10,000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Enzepi 10 000
English: Enzepi 40,000 units gastro-resistant hard capsules
Croatian: Enzepi 40 000 jedinica želučanootporne tvrde kapsule
English: There was no wash-out period.
Croatian: Nije bilo perioda ispiranja prethodnog lijeka iz organizma.
English: Enzepi 40,000 units gastro-resitant hard capsules One capsule contains 334.9 mg of pancreas powder including the following enzymatic activites: - lipolytic activity:
Croatian: Enzepi 40 000 jedinica želučanootporne tvrde kapsule Jedna kapsula lijeka Enzepi sadrži 334,9 mg praška gušterače uključujući sljedeće enzimske aktivnosti: - lipolitička aktivnost:
English: Enzepi 5,000 units gastro-resistant hard capsules One capsule contains 39.8 mg of pancreas powder including the following enzymatic activities: - lipolytic activity:
Croatian: Enzepi 5000 jedinica želučanootporne tvrde kapsule Jedna kapsula sadrži 39,8 mg praška gušterače uključujući sljedeće enzimske aktivnosti: - lipolitička aktivnost:
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT Risk Management Plan (RMP)
Croatian: Plan upravljanja rizikom (RMP)
English: The Enzepi 25,000 units gastro-resistant hard capsule has a green opaque cap and a white opaque body with ‘Enzepi 25' printed on it and contains light-brown gastro-resistant granules.
Croatian: Enzepi želučanootporna tvrda kapsula od 25 000 jedinica ima zelenu neprozirnu kapicu i bijelo neprozirno tijelo, s otisnutim "Enzepi 25" na njoj i sadrži svijetlosmeđe želučanootporne granule.
English: Your doctor will adjust your dose which will depend on: the severity of your illness, how much fat is in your stools, your diet, your weight.
Croatian: Vaš liječnik će prilagoditi dozu koja će ovisiti o:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 25,000 unit strength
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Jačina 25 000 jedinica
English: INFORMATION IN BRAILLE Enzepi 5,000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Enzepi 5000
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 25,000 unit strength
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE - Jačina 25 000 jedinica
English: The Enzepi 40,000 units gastro-resistant hard capsule has a blue opaque cap and a white opaque body with ‘Enzepi 40' printed on it and contains light-brown gastro-resistant granules.
Croatian: Enzepi želučanootporna tvrda kapsula od 40 000 jedinica ima plavu neprozirnu kapicu i bijelo neprozirno tijelo, s otisnutim "Enzepi 40" na njoj i sadrži svijetlosmeđe želučanootporne granule.
English: Enzepi 10,000 units gastro-resistant hard capsules
Croatian: Enzepi 10 000 jedinica želučanootporne tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Enzepi 25,000 units gastro-resistant hard capsules Pancreas powder
Croatian: NAZIV LIJEKA Enzepi 25 000 jedinica želučanootporne tvrde kapsule gušterača, prašak
English: Enzepi 5,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water.
Croatian: Enzepi 5000 jedinica: hipromeloza, karagenan (E407), kalijev klorid, titanijev dioksid (E171), karnauba vosak, voda.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 5,000 unit strength
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Jačina 5000 jedinica
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 209.3 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Croatian: TVARI Jedna kapsula sadrži 209,3 mg praška gušterače svinjskog podrijetla uključujući sljedeće enzimske aktivnosti: lipolitička aktivnost:
English: Enzepi 25,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172), indigotine E132.
Croatian: Enzepi 25 000 jedinica: hipromeloza, karagenan (E407), kalijev klorid, titanijev dioksid (E171), karnauba vosak, voda, žuti željezov oksid (E172), indigotin (E132).
English: The Enzepi 5,000 units gastro-resistant hard capsule has a white opaque cap and a white opaque body with ‘Enzepi 5' printed on it and contains light-brown gastro-resistant granules.
Croatian: Enzepi želučanootporna tvrda kapsula od 5000 jedinica ima bijelu neprozirnu kapicu i bijelo neprozirno tijelo, s otisnutim "Enzepi 5" na njoj i sadrži svijetlosmeđe želučanootporne granule.
English: The Enzepi 10,000 units gastro-resistant hard capsule has a yellow opaque cap and a white opaque body with ‘Enzepi 10' printed on it and contains light-brown gastro-resistant granules.
Croatian: Enzepi želučanootporna tvrda kapsula od 10 000 jedinica ima žutu neprozirnu kapicu i bijelo neprozirno tijelo, s otisnutim "Enzepi 10" na njoj i sadrži svijetlosmeđe želučanootporne granule.
English: Enzepi 10,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172).
Croatian: Enzepi 10 000 jedinica: hipromeloza, karagenan (E407), kalijev klorid, titanijev dioksid (E171), karnauba vosak, voda, žuti željezov oksid (E172).
English: units amylase:
Croatian: Eur. jedinica amilazu:
English: NAME OF THE MEDICINAL PRODUCT Enzepi 40,000 units gastro-resistant hard capsules Pancreas powder
Croatian: NAZIV LIJEKA Enzepi 40 000 jedinica želučanootporne tvrde kapsule gušterača, prašak
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 40,000 unit strength
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Jačina 40 000 jedinica
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Croatian: TVARI Jedna kapsula sadrži 334,9 mg praška gušterače svinjskog podrijetla uključujući sljedeće enzimske aktivnosti: lipolitička aktivnost:
English: Enzepi 40,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, indigotine (E132).
Croatian: Enzepi 40 000 jedinica: hipromeloza, karagenan (E407), kalijev klorid, titanijev dioksid (E171), karnauba vosak, voda, indigotin (E132).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 40,000 unit strength
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE - Jačina 40 000 jedinica
English: Enzepi 5,000 units gastro-resistant hard capsules
Croatian: Enzepi 5000 jedinica želučanootporne tvrde kapsule
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10,000 unit strength
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Jačina 10 000 jedinica
English: One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities:
Croatian: Jedna kapsula sadrži 83,7 mg praška gušterače svinjskog podrijetla uključujući sljedeće enzimske aktivnosti: lipolitička aktivnost;
English: EU/1/16/1113/013 20 gastro-resistant hard capsules EU/1/16/1113/014 50 gastro-resistant hard capsules EU/1/16/1113/015 100 gastro-resistant hard capsules EU/1/16/1113/016 200 gastro-resistant hard capsules
Croatian: EU/1/16/1113/013 20 želučanootpornih tvrdih kapsula EU/1/16/1113/014 50 želučanootpornih tvrdih kapsula EU/1/16/1113/015 100 želučanootpornih tvrdih kapsula EU/1/16/1113/016 200 želučanootpornih tvrdih kapsula
English: EU/1/16/1113/005 20 gastro-resistant hard capsules EU/1/16/1113/006 50 gastro-resistant hard capsules EU/1/16/1113/007 100 gastro-resistant hard capsules EU/1/16/1113/008 200 gastro-resistant hard capsules
Croatian: EU/1/16/1113/005 20 želučanootpornih tvrdih kapsula EU/1/16/1113/006 50 želučanootpornih tvrdih kapsula EU/1/16/1113/007 100 želučanootpornih tvrdih kapsula EU/1/16/1113/008 200 želučanootpornih tvrdih kapsula
English: NAME OF THE MEDICINAL PRODUCT Enzepi 10,000 units gastro-resistant hard capsules Pancreas powder
Croatian: NAZIV LIJEKA Enzepi 10 000 jedinica želučanootporne tvrde kapsule gušterača, prašak
English: NAME OF THE MEDICINAL PRODUCT Enzepi 5,000 units gastro-resistant hard capsules Pancreas powder
Croatian: NAZIV LIJEKA Enzepi 5000 jedinica želučanootporne tvrde kapsule gušterača, prašak
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva oticanje lica urtikarija generalizirani osip osip eritematozni osip svrbež
English: EU/1/16/1113/009 20 gastro-resistant hard capsules EU/1/16/1113/010 50 gastro-resistant hard capsules EU/1/16/1113/011 100 gastro-resistant hard capsules EU/1/16/1113/012 200 gastro-resistant hard capsules
Croatian: EU/1/16/1113/009 20 želučanootpornih tvrdih kapsula EU/1/16/1113/010 50 želučanootpornih tvrdih kapsula EU/1/16/1113/011 100 želučanootpornih tvrdih kapsula EU/1/16/1113/012 200 želučanootpornih tvrdih kapsula
English: Triethyl citrate
Croatian: KG Pinnauallee 4
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 10,000 unit strength
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE - Jačina 10 000 jedinica
English: EU/1/16/1113/001 20 gastro-resistant hard capsules EU/1/16/1113/002 50 gastro-resistant hard capsules EU/1/16/1113/003 100 gastro-resistant hard capsules EU/1/16/1113/004 200 gastro-resistant hard capsules
Croatian: EU/1/16/1113/001 20 želučanootpornih tvrdih kapsula EU/1/16/1113/002 50 želučanootpornih tvrdih kapsula EU/1/16/1113/003 100 želučanootpornih tvrdih kapsula EU/1/16/1113/004 200 želučanootpornih tvrdih kapsula
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija**
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Croatian: Jedna kapsula sadrži 39,8 mg praška gušterače svinjskog podrijetla uključujući sljedeće enzimske aktivnosti: lipolitička aktivnost:
English: 2 Co-ordination group for mutual recognition and decentralised procedures - human
Croatian: 2 Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove
English: • The Committee considered the notification of the referral triggered by Hungary under Article 29(4) of Directive 2001/83/EC where Germany raised objections that were considered to be a potential serious risk to public health;
Croatian: • Povjerenstvo je razmotrilo obavijest o postupku upućivanja koji je pokrenula Mađarska u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ jer je Njemačka uputila prigovor smatrajući da bi mogao postojati ozbiljan rizik za zdravlje ljudi;
English: 1 Following the outcome of an Article 31 referral procedure on tolperisone-containing medicinal products, for which a Commission decision was adopted in January 2013.
Croatian: 1 Prema rezultatima postupka upućivanja, u skladu s člankom 31. za lijekove koji sadrže tolperizon vezano za koje je u siječnju 2013. donesena odluka Komisije.
English: The marketing authorisation application (MAA) for Merisone was submitted under Article 10(1) of Directive 2001/83/EC (i.e. a generic application), vis-à-vis the reference medicinal product Mydeton (Gedeon Richter Plc).
Croatian: Zahtjev za stavljanje u promet lijeka Merisone podnesen je u skladu s člankom 10. stavkom 1. Direktive 2001/83/EZ (zahtjev za generički lijek) u odnosu na referentni lijek Mydeton (Gedeon Richter Plc).
English: During the CMDh2 referral procedure that followed the mutual recognition procedure (MRP), no consensus could be reached as the objecting member state maintained its objection, which was thought to represent a potential serious risk to public health.
Croatian: Tijekom postupka upućivanja CMDh-u2 koji je uslijedio nakon postupka međusobnog priznavanja nije postignut konsenzus, jer je država članica koja je uložila prigovor ostala pri svom prigovoru, smatrajući da lijek predstavlja potencijalno ozbiljan rizik za javno zdravlje.
English: The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Croatian: Zbog toga je CMDh predmet uputio CHMP-u u okviru postupka upućivanja u skladu s člankom 29. stavkom 4.
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the bioequivalence of Merisone with respect to the reference medicinal product;
Croatian: • Povjerenstvo je pregledalo sve odgovore koje je dostavio podnositelj zahtjeva vezano za problem bioekvivalencije lijeka Merisone u odnosu na referentni lijek;
English: Since the effect of these excipients would be diluted in the presence of food, it was considered unlikely that excipients such as mannitol would be larger in fed conditions compared to fasting conditions, given that the effect of mannitol is based on its osmotic effect.
Croatian: Budući da bi učinak tih pomoćnih tvari bio razblažen u prisustvu hrane, smatra se da nije vjerojatno da bi učinak pomoćnih tvari kao što je manitol bio viši u uvjetima uz hranu nego natašte, s obzirom da se učinak manitola temelji na njegovom osmotskom učinku.
English: The active substance of Merisone is tolperisone hydrochloride, which is a centrally acting muscle relaxant indicated for the symptomatic treatment of post-stroke spasticity in adults.
Croatian: Djelatna tvar lijeka Merisone je tolperizon hidroklorid, mišićni relaksans koji djeluje na središnji živčani sustav, a indiciran je za simptomatsko liječenje spastičnosti u odraslih nakon moždanog udara.
English: Furthermore it was argued that serious concerns remained as to whether the test product in this case (that is advised to be taken concomitantly with food), would be bioequivalent under fed conditions, given that the results of the bioequivalence studies under fasted conditions were borderline.
Croatian: Nadalje, izraženo je mišljenje da ostaje ozbiljna sumnja bi li testirani proizvod u ovom slučaju (za koji se preporučuje da se uzima s hranom) bio bioekvivalent u uvjetima uz hranu, budući da su rezultati ispitivanja bioekvivalencije u uvjetima natašte bili granični.
English: Therefore it was considered that fasting bioequivalence studies are expected to be more sensitive to detect formulation differences.
Croatian: Stoga se smatralo da se ispitivanjima bioekvivalencije u uvjetima natašte lakše mogu otkriti razlike među formulacijama.
English: Because the within-subject coefficient of variation is higher than 30%, the applicant was of the view that according to the current bioequivalence guideline extended limits could have been used to show bioequivalence, which would have been in this case 71.25%
Croatian: Budući da je intraindividualni koeficijent varijacije viši od 30 %, podnositelj zahtjeva smatrao je da su se u skladu s trenutačnim smjernicama za bioekvivalenciju mogla primijeniti proširena ograničenja za dokazivanje bioekvivalencije koja bi u tom slučaju iznosila 71,25 % - 140,35 %.
English: The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group, for Merisone and associated names (see Annex I).
Croatian: CHMP je preporučio izdavanje odobrenja za stavljanje u promet za koje sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ostaju u skladu sa završnim inačicama donesenim tijekom postupka koordinacijske grupe za lijek Merisone i povezana imena (vidjeti Prilog I.).
English: The objecting concerned member state (CMS) was of the view that a similar extent of the food effect that was shown for the two different products referred to above, does not have to hold true for this generic formulation since it has not been proven that the food effect is a characteristic of the active substance and not a formulation related factor.
Croatian: Država članica u postupku (CMS) koja je uložila prigovor smatrala je da sličan razmjer učinka hrane koji je dokazan za gore spomenute proizvode ne mora biti takav i u slučaju generičke formulacije, budući da nije dokazano da je učinak hrane karakteristika djelatne tvari, a ne čimbenik vezan uz formulaciju.
English: • Therefore, the Committee concluded by majority that the bioequivalence studies conducted in the fasting state give sufficient evidence to conclude on the bioequivalence also in the fed state since Merisone contains a highly soluble and highly permeable active substance, and pharmacokinetic principles and convincing experimental evidence suggest that the food effect of this active substance is formulation independent.
Croatian: • Stoga je Povjerenstvo većinom glasova zaključilo da rezultati ispitivanja bioekvivalencije u uvjetima natašte pružaju dovoljno dokaza iz kojih se može zaključiti da je lijek bioekvivalentan i u stanju sitosti, budući da Merisone sadrži vrlo topivu i vrlo propusnu djelatnu tvar, a farmakokinetska načela i uvjerljivi eksperimentalni dokazi ukazuju na to da učinak hrane na djelatnu tvar ne ovisi o formulaciji.
English: As there is no evidence that the food-effect is formulation dependent and the formulation is a conventional one, some of the PKWP members considered that a bioequivalence study in the fasting state was acceptable in this case.
Croatian: Budući da nema dokaza da učinak hrane ovisi o formulaciji, a formulacija je konvencionalna, neki članovi PKWP-a smatrali su da je ispitivanje bioekvivalencije u uvjetima natašte u ovom slučaju prihvatljivo.
English: The majority of the CHMP members agreed that in vivo dissolution differences between formulations are likely to be less apparent and more difficult to observe in fed conditions since gastric emptying time is longer in the fed state than in the fasting state.
Croatian: Većina članova CHMP-a bila je suglasna da su razlike u in vivo rastvorivosti među formulacijama vjerojatno manje vidljive i teže uočljive u uvjetima uz hranu budući da pražnjenje želuca traje dulje u uvjetima sitosti nego u uvjetima natašte.
English: The Pharmacokinetics Working Party (PKWP) was also consulted to seek their view on whether there is any scientific reasoning that tolperisone (classified as a highly variable drug as the within-subject variability of the Cmax of the reference medicinal product was 46.99%) may have the option of showing bioequivalence in either the fasted or fed state.
Croatian: Zatraženo je i mišljenje Radne skupine za farmakokinetiku (PKWP) o tome postoje li znanstveni razlozi zbog kojih bi tolperizon (klasificiran kao vrlo varijabilan lijek budući da je Cmax intraindividualne varijabilnosti referentnog lijeka iznosio 46,99 %) mogao pokazivati bioekvivalenciju samo u uvjetima natašte ili uz hranu.
English: Since the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention a food effect, the MAA that was submitted for Merisone included two bioequivalence studies with 50 and 150 mg tolperisone film-coated tablets conducted under fasting conditions with 52 volunteers each.
Croatian: Budući da SmPC referentnog lijeka nije sadržavao preporuke vezane za hranu i nije spominjao učinak hrane, zahtjev za stavljanje lijeka u promet koji je podnesen za Merisone uključivao je dva ispitivanja bioekvivalencije s filmom obloženim tabletama od 50 i 150 mg tolperizona provedena u uvjetima natašte s po 52 dobrovoljca.
English: The applicant highlighted that, at the time the bioequivalence studies were performed, the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention that the food effect was significant.
Croatian: Podnositelj zahtjeva naglasio je da u trenutku provođenja ispitivanja bioekvivalencije sažetak opisa svojstava lijeka (SmPC) referentnog lijeka nije sadržavao preporuke vezane za hranu i da nije bilo navedeno kako je učinak hrane značajan.
English: The information that was introduced in the SmPC of tolperisone was based on two well-designed studies conducted with different formulations of tablets, which showed that compared to the fasting state, fat-rich food increases the bioavailability of tolperisone by about
Croatian: Informacije koje su uvrštene u SmPC za tolperizon temeljile su se na dva dobro razrađena ispitivanja provedena s različitim formulacijama tableta, koja su pokazala da hrana bogata mastima u odnosu na uvjete natašte povećava bioraspoloživost tolperizona za oko 100 %.
English: Although the results of the bioequivalence studies were considered to be borderline by the objecting CMS, the applicant argued that the second bioequivalence study was a replicate design study where it was shown that tolperisone is a highly variable drug - the within-subject variability of the reference medicinal product Cmax was 46.99%.
Croatian: Iako je CMS koji je uložio prigovor smatrao da su rezultati ispitivanja bioekvivalencije granični, podnositelj zahtjeva tvrdio je da je drugo ispitivanje bioekvivalencije predstavljalo ponovljeno ispitivanje u kojem je dokazano da je tolperizon vrlo varijabilan lijek - Cmax intraindividualne varijabilnosti referentnog lijeka iznosio je 46,99 %.
English: As there is no evidence that the food-effect is formulation dependent, the majority of the CHMP concluded that the bioequivalence studies conducted in the fasting state, which is considered to be the most sensitive condition, would give sufficient evidence to conclude on the bioequivalence in both the fasting and fed states in this particular case.
Croatian: Budući da nema dokaza da učinak hrane ovisi o formulaciji, većina članova CHMP-a zaključila je da ispitivanja bioekvivalencije provedena u uvjetima natašte, koji se smatraju najosjetljivijim uvjetima, pružaju dovoljno dokaza za donošenje zaključka o bioekvivalenciji u stanju sitosti i natašte u ovom konkretnom slučaju.
English: Taking into account that the MAH had submitted data which showed that tolperisone is a highly soluble and highly permeable active substance, neither solubility nor dissolution was considered to be a limiting factor in terms of in vivo absorption.
Croatian: Uzimajući u obzir da je nositelj odobrenja za stavljanje lijeka u promet dostavio podatke koji pokazuju da je tolperizon vrlo topiva i vrlo propusna djelatna tvar, smatra se da ni topivost ni rastvorivost nisu ograničavajući čimbenici u pogledu in vivo apsorpcije.
English: Taking into account all the evidence and arguments presented, the majority of the CHMP noted that that bioequivalence had been demonstrated in the fasting state for tolperisone, which is highly soluble and highly permeable active substance, demonstrating high within-subject variability.
Croatian: Uzimajući u obzir sve iznesene dokaze i argumente, većina članova CHMP-a smatrala je da je u uvjetima natašte dokazana bioekvivalencija za tolperizon, koji je vrlo topiva i vrlo propusna djelatna tvar s vrlo visokom intraindividualnom varijabilnošću.
English: In the study with the 50 mg tablet, bioequivalence was not demonstrated as the upper limit of the Cmax was outside the upper band, i.e.
Croatian: U ispitivanju tableta od 50 mg bioekvivalencija nije dokazana budući da je najviša vrijednost Cmax bila izvan gornjeg ograničenja, odnosno 125,49 %.
English: Therefore the objecting member state was of the view that the two bioequivalence submitted with the 50 and 150mg tolperisone tablets under fasting conditions were not sufficient, and that bioequivalence should be demonstrated under fed conditions.
Croatian: Stoga je država članica koja je uložila prigovor smatrala da dva ispitivanja bioekvivalencije podnesena za tablete s 50 i 150 mg tolperizona u uvjetima natašte nisu dostatna te da bioekvivalenciju treba dokazati u uvjetima uz hranu.
English: • The Committee was of the view that results of the submitted bioequivalence studies showed that Merisone 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
Croatian: • Povjerenstvo smatra da su rezultati dostavljenih ispitivanja bioekvivalencije pokazali da su tablete Merisone od 50 i 150 mg bioekvivalenti referentnog lijeka Mydeton u obliku tableta od 50 i 150 mg u uvjetima natašte;