natgillin/translations-raw huggingface dataset:
None of the 6 above-mentioned studies provide data to support the proposed indication and treatment duration that could not be derived from the other 11 studies provided in the application. 
Nobena od 6 zgoraj omenjenih študij ne daje podatkov v podporo predlagani indikaciji in trajanju zdravljenja, ki jih ne bi mogli izpeljati iz ostalih 11 študij, priloženih v vlogi.
Overall this study provides no relevant data analogous to the initial non-prescription medication period of up to 14 days. 
Na splošno ta študija ne daje nikakršnih pomembnih podatkov, ki bi bili analogni prvotnemu obdobju izdajanja zdravila brez recepta do 14 dni.
• the applicant's justification to extrapolate the results of these studies to the proposed non prescription setting is acceptable 
• predlagateljeva utemeljitev o prenosu rezultatov teh študij na predlagano izdajanje zdravila brez recepta je sprejemljiva;
The results showed that all of the above doses are effective and comparable in the treatment of GORD. 
Rezultati so pokazali, da so vsi zgoraj omenjeni odmerki učinkoviti in primerljivi pri zdravljenju gastroezofagelane refluksne bolezni.
Based on the above results the CHMP considered the following: 
CHMP je na podlagi zgornjih rezultatov ugotovil:
322 There was no statistically significant difference between the treatment groups 
322 Med obema skupinama zdravljenja ni bilo pomembne statistične razlike
Quality of life, Time to heartburn relief 
Kakovost življenja, čas do olajšanja zgage
Similar results were shown in the published study M3 
Podobni so bili rezultati v objavljeni študiji M3-316.
The study contained a treatment phase C; days 29-56, but again, this is not relevant to a non-prescription indication of no more than 28 days. 
Študija je vsebovala fazo C zdravljenja med 29. in 56. dnevom, vendar pa to ni pomembno za indikacijo izdajanja zdravila brez recepta za manj kot 28 dni.
No day 14 data was available in the study report. 
V študijskem poročilu ni bilo podatkov za 14. dan.
Results are similar to published studies (FK3059, VMG306, FK3034 and BGSA006) 
Rezultati so podobni objavljenim študijam (FK3059, VMG306, FK3034 in BGSA006)
14 day data was not provided by this study. 
V tej študiji niso bili predloženi podatki za 14 dni.
The applicant also referred to studies BF010 (CSR 298E/99) and VMG309 (CSR 323/2004) which were considered to provide data for early onset of relief of reflux symptoms. 
Predlagatelj se je prav tako skliceval na študiji BF010 (CSR 298E/99) in VMG309 (CSR 323/2004), ki naj bi zagotavljali podatke o zgodnjem nastopu lajšanja simptomov refluksa.
Pantoprazole was noninferior to lansoprazole after 4 weeks of treatment 
Pantoprazol ni dosegal slabših rezultatov od lansoprazola po 4 tednih zdravljenja
The applicant, in addition to study BGI022 (CSR 257/2004), referred to study MEX020 (CSR 200/2004). 
Predlagatelj se je poleg študije BGI022 (CSR 257/2004) skliceval tudi na študijo MEX020 (CSR 200/2004).
The applicant emphasised that these studies demonstrated efficacy in the non-prescription setting regarding the proposed indication and related posology which differs from that of the prescription product. 
Predlagatelj je poudaril, da te študije dokazujejo učinkovitost izdajanja zdravila brez recepta za predlagano indikacijo in s tem povezano odmerjanje, ki se razlikuje od tistega pri zdravilu na recept.
Out of the 17 studies provided by the applicant, the following 6 studies formed the basis of the applicant's request for data exclusivity: 
Izmed 17 študij, ki jih je predložil predlagatelj, je naslednjih 6 študij vsebovalo podlago za predlagateljevo zahtevo za izključno pravico do uporabe podatkov:
the CHMP concluded that the studies BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309 submitted by the applicant for which the claim of one year data exclusivity is sought, were not relevant and necessary to the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ‘medicinal product not subject to medical prescription'. 
CHMP je zaključil, da študije BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 in BY1023/VMG309, ki jih je predložil predlagatelj in za katere je zahteval enoletno izključno pravico do uporabe podatkov, niso pomembne in potrebne za razvrstitev zdravila CONTROLOC Control 20 mg gastrorezistente tablete v skupino „zdravil, ki se izdajajo brez recepta“.
• pantoprazole 20mg is effective in the short-term treatment of GORD symptoms 
• pantoprazol 20 mg je učinkovit za kratkotrajno zdravljenje simptomov GERB;
4 weeks 
4 tedne
Nycomed GmbH, D-78467 Konstanz 
Nycomed GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Nemčija
Endoscopic healing erosive esophagitis 
Endoskopsko zdravljenje erozivnega ezofagitisa
The shortcomings of this study are the same as described above for study BF010: lack of day 14 makes this study of limited value in the non-prescription context where the patient would be self-referring to their physician if no symptomatic relief was obtained by day 14. 
Slabosti te študije so enake tistim, opisanim zgoraj za študijo BF010: zaradi pomanjkanja podatkov ob 14. dnevu ima ta študija omejeno vrednost za zdravila, ki se izdajajo brez recepta, ob jemanju katerih bi se bolnik, če se simptomi do 14. dne ne bi izboljšali, sam napotil k zdravniku.
weeks 
tednov
The recommended dose is 20 mg pantoprazole (one tablet) per day. 
Priporočeni odmerek je 20 mg pantoprazola (1 tableta) na dan.
Primary Objective Secondary Objective Treatment Duration 
Primarni cilj Sekundarni cilj Zdravljenj e
In this pivotal study the differences between pantoprazole 20 mg and ranitidine 150 mg results were significant; however the unpublished study conclusion for BGI022 were very similar to those of the published ranitidine 150 mg comparative study VMG306 and overall does not add significant value to the application. 
V tej ključni študiji so bile pomembne razlike med rezultati za pantoprazol 20 mg in rezultati za ranitidin 150 mg; vendar so bili zaključki neobjavljene študije BGI022 zelo podobni zaključkom objavljene primerjalne študije VMG306 za ranitidin 150 mg, študija pa na splošno vlogi ne doda pomembne vrednosti.
The study concluded that pantoprazole 20 mg has a trend to have a faster relief of symptoms during the first 7 days of treatment compared with omeprazole 10 mg, but no statistically significant differences were found after 7 days, 4 weeks or 8 weeks treatment between the groups. 
V študiji so zaključili, da ima pantoprazol 20 mg, v primerjavi z omeprazolom 10 mg, tendenco hitrejšega lajšanja simptomov v prvih 7 dneh zdravljenja, vendar pa statistično pomembne razlike med skupinama po 7 dneh, 4 tednih ali 8 tednih zdravljenja niso opazili.
Study BY1023/BGI022 was particularly emphasised. 
Zlasti je bila poudarjena študija BY1023/BGI022.
Out of the 17 studies submitted in support of the application, the following 11 studies did not form the basis of the applicant's request for data exclusivity: 
Izmed 17 študij, predloženih v podporo vlogi, naslednjih 11 študij ni vsebovalo podlage za predlagateljevo zahtevo za izključno pravico do uporabe podatkov:
Pan 10, 20, 40, Pla weeks 
Pan 10, 20, 40, Pla tednov
RESULTS 
Rezultati
Similar results were shown by study FK3059, VMG306, FK3034, BGSA006, which also showed superiority of 20 mg pantoprazole compared to 300 mg ranitidine in the treatment of reflux symptoms. 
Podobni so bili rezultati študij FK3059, VMG306, FK3034, BGSA006, v katerih so prav tako pokazali večjo učinkovitost 20 mg pantoprazola v primerjavi s 300 mg ranitidina pri zdravljenju simptomov refluksa.
Tablets are yellow, oval, biconvex, film-coated and imprinted with “P20” in brown ink on one side. 
Rumene, ovalne, bikonveksne filmsko obložene tablete z odtisom »P 20« v rjavi barvi na eni strani.
Pan 20, 40 4 weeks 
Pan 20, 40 4 tedne
Relief of symptoms in GORD Stage A-D 
Olajšanje simptomov pri GERB stopnjah A-D
Relief of GORD symptoms, Time to heartburn relief 
Olajšanje simptomov GERB, čas do olajšanja zgage
270 Pantoprazole was superior to ranitidine 
270 Pantoprazol je dosegal boljše rezultate od ranitidina
Study No. (CSR No.) 
Št. študije (št. CSR)
The results show that symptom relief rates are largely independent of the initial GORD stage of the patients. 
Zmanjšanje simptomov refluksa kisline je bilo večinoma neodvisno od začetne stopnje GERB.
The findings of this study are in line with other published studies (Study VMG305 and M3-320), which showed that the efficacy of pantoprazole is noninferior to other PPIs (such as lansoprazole and esomeprazole). 
Ugotovitve te študije so v skladu z ostalimi objavljenimi študijami (študiji VMG305 in M3-320), ki so pokazale, da pantoprazol ni manj učinkovit od drugih zaviralcev protonskih črpalk (kot sta lansoprazol in esomeprazol).
Similar results were shown in the published study M3-316 which compared the efficacy of 20 and 40 mg pantoprazole in the treatment of GORD symptoms. 
Podobni so bili rezultati objavljene študije M3-316, v kateri so primerjali učinkovitost 20 in 40 mg pantoprazola pri zdravljenju simptomov gastroezofagealne refluksne bolezni.
No week 2 relief rate analysis was provided. 
Analize olajšanja simtomov v 2. tednu niso bile na voljo.
Treatment Duration N (ITT) 
Trajanje Št. (ITT)
Overall the applicant considered that the new data from the aforementioned studies added significant support to the classification as non-prescription product as they provided both effect and relevance to the assessment. 
Na splošno je predlagatelj menil, da ti novi podatki iz prej omenjenih študij zaradi svojega pomena in učinka na oceno pomembno podpirajo razvrstitev v skupino zdravil, ki se izdajajo brez recepta.
Relief of leading GORD symptoms and other GI symptoms 
Olajšanje glavnih simptomov GERB in drugih gastrointestinalnih simptomov
The justification of the applicant was based on 6 ‘non-published' studies, 5 full and one published by abstract only, which have been provided in support of the application (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309). 
Študije so bile predložene kot podpora vlogi (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 in BY1023/VMG309).
In the non-prescription product setting, the patient would be self-referring to their physician if no symptomatic relief was obtained by day 14, making this study of limited value in the non-prescription context. 
V primeru izdajanja zdravila brez recepta bi se bolnik, če se do 14. dneva simptomi ne bi izboljšali, sam napotil k zdravniku, zaradi česar ima ta študija omejeno vrednost za zdravila, ki se izdajajo brez recepta.
• Risk and consequences of incorrect use 
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
With reference to Article 74a of Directive 2001/83/EC, as amended, the applicant requested one year data exclusivity for the data submitted for the change of the classification of the medicinal product 
V skladu s členom 74(a) Direktive 2001/83/ES, kakor je bila spremenjena, je predlagatelj zahteval enoletno izključno pravico do uporabe podatkov, ki so bili predloženi za spremembo razvrstitve zdravila iz skupine zdravil, ki se izdajajo le na recept, v skupino zdravil, ki se izdajajo brez recepta.
Time to first symptom relief of GORDrelated symptoms in GORD Stage 0 
Čas do prvega olajšanja z GERB povezanih simptomov pri GERB stopnje 0
Additionally, the usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole. 
Poleg tega je običajni začetni odmerek omeprazola za refluksno bolezen 20 mg; 10 mg omeprazola ni terapevtsko enakovrednih 20 mg pantoprazola.
Both PPIs were comparably effective; pantoprazole was noninferior to esomeprazole 
Oba zaviralca protonske črpalke sta primerljivo učinkovita; pantoprazol ni dosegal slabših rezultatov od esomeprazola
Assessment of GI symptoms at day 14 and 
Ocena gastrointestinalnih simptomov na 14. in 28. dan
The usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole. 
Običajni začetni odmerek omeprazola pri refluksni bolezni je 20 mg; 10 mg omeprazola ni terapevtsko enakovrednih 20 mg pantoprazola.
Endoscopic healing of GORD Stage I after 8 weeks, Improvement of GORD symptoms after 2 and 4 weeks 
Endoskopsko zdravljenje GERB stopnje I po 8 tednih, izboljšanje simptomov GERB po 2 in 4 tednih
The CHMP reviewed the clinical data submitted, taking into account the provisions of Article 74a of Directive 2001/83/EC, as amended, in support of the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ‘medicinal product not subject to medical prescription'. 
CHMP je ob upoštevanju določb člena 74(a) Direktive 2001/83/ES, kakor je bila spremenjena, pregledal predložene klinične podatke, ki podpirajo razvrstitev zdravila CONTROLOC Control 20 mg gastrorezistentne tablete v skupino „zdravil, ki se izdajajo brez recepta“.
Symptom relief at 2 and 4 weeks of treatment 
Olajšanje simptomov v 2. in 4. tednu zdravljenja
Pantoprazole was effective and well tolerated 
Pantoprazol je bil učinkovit in bolniki so ga dobro prenašali
This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg after one and two weeks or treatment. 
V študiji so primerjali učinkovitost omeprazola 10 mg in pantoprazola 20 mg po enem in po dveh tednih zdravljenja.
Additionally, in other studies efficacy of pantoprazole was compared to other PPIs (lansoprazole, esomeprazole) and it was found to be non-inferior to these PPIs in relieving symptoms of heartburn and acid regurgitation (Study VMG305 and M3-320). 
Poleg tega so v drugih študijah primerjali učinkovitost pantoprazola z drugimi zaviralci protonske črpalke (z lansoprazolom, esomeprazolom) in ugotovili, da ni dosegal slabših rezultatov od teh zdravil pri lajšanju simptomov zgage in regurgitacije kisline (študiji VMG305 in M3-320).
Overall treatment duration without consultation of a doctor is limited to 4 weeks; if no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. 
Če ne pride do olajšanja simptomov v 2 tednih neprekinjenega zdravljenja, je treba bolnika napotiti na posvet k zdravniku.
Leading symptom relief after 2 weeks of treatment 
Olajšanje glavnega simptoma po 2 tednih zdravljenja
Relief of GORD-related symptoms after 14 and 28 days 
Olajšanje z GERB povezanih simptomov po 14 in 28 dneh
The approved indication is: 
Navodilo vsebuje:
Pantoprazole was superior to ranitidine in the treatment of key GORD symptoms. 
Pantoprazol je bil pri zdravljenju glavnih simptomov gastroezofagealne refluksne bolezni učinkovitejši od ranitidina.
Medicinal Product 
FARMACEVTSKI PODATKI
were given. 
Navodilo je bilo odobreno
2 weeks 521 Both PPIs were comparably effective; pantoprazole was noninferior to omeprazole, nonsignificant primary endpoint 
2 tedna 521 Oba zaviralca protonske črpalke sta primerljivo učinkovita; pantoprazol ni dosegal slabših rezultatov od
CSR = Clinical Study Report, N = Number of Patients, Eso = Esomeprazole, Lan = Lansoprazole, Niz = Nizatidine, Ome = Omeprazole, Pan = Pantoprazole, Pla = Placebo, Ran = Ranitidine, bid =twice daily 
Pantoprazol in omeprazol sta bila primerljivo učinkovita CSR = poročilo klinične študije (Clinical Study Report), Št. (ITT) = število bolnikov, ki so jih nameravali zdraviti (Intent To Treat), Eso = esomeprazol, Lan = lansoprazol, Niz = nizatidin, Ome = omeprazol, Pan = pantoprazol, Pla = placebo, Ran = ranitidin
Pantoprazole was significantly more effective than placebo 
Pantoprazol je bil bistveno učinkovitejši od placeba
Treatments 
ZDRAVILA
Endoscopic healing of GORD Stage II/III after 4 and 8 weeks of treatment 
Endoskopsko zdravljenje GERB stopnje II/III po 4 in 8 tednih zdravljenja
- Marketing authorisation number: 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Comments 
Pripombe
The CHMP noted that in the majority of the studies patients were included based on endoscopic examination rather than symptoms alone. 
Diagnoza GERB v teh študijah je temeljila na endoskopski oceni, z izjemo ene študije, v katero so bili vključeni bolniki zgolj na osnovi simptomov.
GERD stage I 
GERB stopnje
Relief of heartburn in GORD Stage I after 1 and 2 weeks of treatment 
Olajšanje zgage pri GERB stopnji I po 1 in 2 tednih zdravljenja
In this study the efficacy of 20 mg pantoprazole was compared to 10 mg omeprazole at day 28 in patients with reflux oesophagitis. 
V tej študiji so primerjali učinkovitost 20 mg pantoprazola z 10 mg omeprazola na 28. dan pri bolnikih z refluksnim ezofagitisom.
Pantoprazole and omeprazole were similarly effective 
346 Pantoprazol in omeprazol sta bila podobno učinkovita
There are potential interactions with anticoagulants and with drugs, which bioavailability is pH dependent such as atanazavir. 
Zdravilo CONTROLOC Control lahko zmanjša absorpcijo zdravilnih učinkovin, katerih biološka razpoložljivost je odvisna od želodčnega pH (npr. ketokonazol).
Relief of typical GORD symptoms 
Olajšanje značilnih simptomov GERB
“Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.” 
Kratkotrajno zdravljenje simptomov refluksa (npr. zgaga, regurgitacija kisline) pri odraslih.
This study compared the efficacy and tolerability of pantoprazole 20 mg, 40 mg, or 80 mg in healing of oesophagitis and freedom from GORD symptoms. 
V tej študiji so primerjali učinkovitost in prenašanje pantoprazola 20 mg, 40 mg ali 80 mg pri zdravljenju ezofagitisa in odsotnosti simptomov gastroezofagealnega refluksa.
There are no direct safety issues that preclude pantoprazole being available as a non-prescription medicine. 
Bolniki ne smejo jemati pantoprazola kot preventivno zdravilo.
It is extensively metabolised in the liver. 
Pantoprazol se skoraj izključno presnavlja v jetrih.
Pan 20, Ran 300 once daily 
Pan 20, Ran 300 enkrat dnevno
Pan 20, 40, Niz 150 bid weeks 
Pan 20, 40, Niz 150 dvakrat dnevno tednov
2.5 Pharmacovigilance 
5.2 Farmakokinetične lastnosti
Pan 20, Ran 300 once daily weeks 
Pan 20, Ran 300 enkrat dnevno tednov
This study compared the efficacy of 20 mg pantoprazole once daily with 150 mg twice daily ranitidine in healing of oesophagitis and freedom from GORD symptoms after treatment. 
V tej študiji so primerjali učinkovitost 20 mg pantoprazola enkrat dnevno s 150 mg ranitidina dvakrat dnevno pri zdravljenju ezofagitisa in odsotnosti simptomov gastroezofagealne refluksne bolezni po zdravljenju.
Pantozol 20 mg gastro-resistant tablets 
CONTROLOC Control 20 mg gastrorezistentne tablete pantoprazol
2.4 Clinical aspects 
4.1 Terapevtske indikacije
Results for the relief of acid regurgitation showed similar results. 
Pri popolnem izboljšanju simptomov regurgitacije kisline so zabeležili podobne rezultate kot pri zgagi.
Relief of GORD symptoms after 2 weeks of treatment 
Olajšanje simptomov GERB po 2 tednih zdravljenja
Clinical studies in elderly patients and in patients with liver or kidney disease did not identify any concerns. 
Pri starejših bolnikih in pri tistih z okvarjeno ledvično ali jetrno funkcijo ni treba prilagajati odmerka.
The main serum metabolite is formed by demethylation at the 4-position of the pyridine ring, followed by conjugation with sulphate. 
Glavni presnovek v serumu in v urinu je desmetilpantoprazol, ki je konjugiran s sulfatom.
Pantoprazole was superior to placebo 
Pantoprazol je dosegal boljše rezultate od placeba
Time to freedom from key GORD symptoms 
Čas do odsotnosti glavnih simptomov GERB
344 Pantoprazole was superior to ranitidine in the relief of GORD symptoms 
4 tedne 344 Pantoprazol je pri lajšanju simptomov GERB dosegal boljše rezultate od ranitidina
The absolute bioavailability of pantoprazole in healthy subjects is 77% and does not change at multiple dosing. 
Absolutna biološka razpoložljivost tablete znaša približno 77%.
Each gastro-resistant tablet contains 20 mg pantoprazole (equivalent of 22.6 mg of pantoprazole sodium sesquihydrate). 
Vsaka tableta vsebuje 20 mg pantoprazola (v obliki natrijevega seskvihidrata).
This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg at day 28 in patients without oesophagitis established by endoscopy. 
V tej študiji so primerjali učinkovitost omeprazola 10 mg in prantoprazola 20 mg na 28. dan pri bolnikih brez ezofagitisa, ugotovljenega z endoskopijo.
Diarrhoea Headache Nausea / Vomiting Abdominal distension and bloating Abdominal pain and discomfort Constipation Dizziness Liver enzymes increased (transaminases, γ-GT) Rash / Exanthema / Eruption Pruritus Sleep disorders Dry mouth Asthenia, fatigue and malaise Hyperlipidaemias and lipid increases Disturbances in vision / Blurred vision Hypersensitivity (incl. 
- Občasni neželeni učinki: glavobol, vrtoglavica, driska, občutek slabosti, bruhanje, napihnjenost in vetrovi, zaprtje, suha usta, bolečina in neugodje v območju trebuha, izpuščaj na koži ali koprivnica, srbenje, občutek slabosti, izčrpanost ali splošno slabo počutje, motnje spanja, povišanje jetrnih encimov v krvni preiskavi.
Relief of heartburn in GORD Stage 0/I at day 14 
Olajšanje zgage pri GERB stopnje 0/I na 14. dan
Enrolment 
Absorpcija
Relief of heartburn in GORD Stage 0/I at day 28 
Olajšanje zgage pri GERB stopnje 0/I na 28. dan
Relief of symptoms in GORD Stage 0/I after 4 weeks of treatment 
Olajšanje simptomov pri GERB stopnje 0/I po 4 tednih zdravljenja
• Clinical studies in special populations 
Posebne skupine bolnikov
The PSUR submission schedule for CONTROLOC Control 20 mg gastro-resistant tablets should follow the PSUR submission schedule of the reference medicinal product. 
Redno dopolnjeno poročilo o varnosti zdravila (PSUR) Urnik oddaje rednih dopolnjenih poročil o varnosti zdravila CONTROLOC Control 20 mg gastrorezistentne tablete sledi urniku oddaje rednih dopolnjenih poročil o varnosti referenčnega zdravila.
Clinical safety 
KLINIČNI PODATKI
• Manufacture 
A. OZNAČEVANJE
The excipients used in the formulation of the finished product are well known excipients used for preparation of tablets such as sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate (present in tablet core), hypromellose, povidone K25, titanium dioxide, yellow iron oxide, methacrylic acid-ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, triethyl citrate (present in film-coating, including enteric coating and undercoating), shellac, red iron oxide, black iron oxide, yellow iron oxide, soya lecithin, titanium dioxide and antifoam DC 1510 (present in printing ink). 
- Obloga: hipromeloza, povidon, titanov dioksid (E 171), rumeni železov oksid (E 172), propilenglikol, kopolimer metakrilne kisline in etilakrilata, natrijev lavrilsulfat, polisorbat 80, trietilcitrat.
European Medicines Agency Evaluation of Medicines for Human Use 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
ASSESSMENT REPORT FOR CONTROLOC Control 
Shranjevanje zdravila CONTROLOC Control Dodatne informacije
This was considered acceptable. 
Navedba smiselno ni potrebna.
Numbers analysed 
ŠTEVILKA SERIJE
Relief of key symptoms in GORD after 28 days 
Olajšanje glavnih simptomov GERB po 28 dneh
Pantoprazole was significantly more effective than ranitidine 
Pantoprazol je bil bistveno učinkovitejši od ranitidina
Relief of key symptoms in GORD after 14 days 
Olajšanje glavnih simptomov GERB po 14 dneh
It acts by inhibiting the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells. 
Pantoprazol je substituiran benzimidazol, ki zavira izločanje klorovodikove kisline v želodcu, s specifičnim delovanjem na protonsko črpalko parietalnih celic .
Relief of GORD 
Olajšanje zgage pri
Relief of heartburn in GORD Stage 0 
Olajšanje zgage pri GERB stopnje 0
Published studies showed noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3 
Objavljene študije kažejo, da pantoprazol ni dosegal slabših rezultatov od drugih zaviralcev protonske črpalke (študiji VGM305 in M3
Randomisation 
Dojenje
from prescription to non-prescription. 
Zdravilo je na voljo brez recepta.
Pharmacokinetics 
Sistrem farmakovigilance