natgillin/translations-raw huggingface dataset:
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO „SAMO ZA ŽIVALI“ IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
BLUEVAC BTV8 stimulates active immunity against bluetongue virus, serotype 8.
BLUEVAC BTV8 spodbuja aktivno imunost proti serotipu 8 virusa bolezni modrikastega jezika.
QUANTITY OF THE ACTIVE SUBSTANCE
KOLIČINA ZDRAVILNE UČINKOVINE
Bluetongue virus inactivated, serotype 8:
inaktiviran virus bolezni modrikastega jezika, serotip 8:
Sheep from 2.5 months of age: Administer two doses of 2 ml subcutaneously with a 3 week interval.
Ovce od starosti 2,5 meseca dalje: dva odmerka po 2 ml subkutano s 3-tedenskim presledkom.
Cattle from 2.5 months of age: Administer two doses of 4 ml subcutaneously with a 3 week interval.
Govedo od starosti 2,5 meseca dalje: dva odmerka po 4 ml subkutano s 3-tedenskim presledkom.
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalc, odgovornega za sproščanje serij
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (52 ml, 100 ml and 252 ml)
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (52 ml, 100ml, 252 ml)
For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Za aktivno imunizacijo ovac od starosti 2,5 meseca dalje za preprečitev viremije* in za zmanjševanje kliničnih znakov, ki jih povzroča serotip 8 virusa bolezni modrikastega jezika.
Pregnancy: Can be used during pregnancy in ewes and cows.
Brejost: Lahko se uporablja v obdobju brejosti ovc in krav.
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN IN POT(I) UPORABE ZDRAVILA
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 52 ml
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Plastenka z 52 ml
Pharmacotherapeutic group: Bluetongue virus vaccines, inactivated.
Farmakoterapevtska skupina: Cepiva proti virusu bolezni modrikastega jezika, inaktivirana.
For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.
Za aktivno imunizacijo goveda od starosti 2,5 meseca dalje za preprečitev viremije* ki jo povzroča serotip 8 virusa bolezni modrikastega jezika.
EXP {month/year} Once opened, use within 10 hours.
Načeto zdravilo uporabite v 10 urah.
Lactation: There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Uporaba cepiva nima nobenih negativnih posledic na mlečnost ovc in krav v obdobju laktacije.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid prečiščen saponin (Quil A)
Box of 1 bottle of 52 ml Box of 1 bottle of 100 ml Box of 1 bottle of 252 ml.
1 plastenka z 52 ml 1 plastenka s 100 ml 1 plastenka z 252 ml
CZ Veterinaria, S.A. 36400 Porriño SPAIN
CZ Veterinaria, S.A. 36400 Porriño ŠPANIJA
Can be used during pregnancy in ewes and cows.
Brejosti in laktacija Lahko se uporablja v obdobju brejosti ovc in krav.
Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after a double dose.
2 cm pri ovcah in do 4,5 cm pri govedu.
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
PRILOGA II A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
Each ml of vaccine contains: Bluetongue virus inactivated, serotype 8
En ml cepiva vsebuje: inaktiviran virus bolezni modrikastega jezika, serotip 8 106,5 CCID50* aluminijev hidroksid
SC
KARENCA
1 bottle + 1 syringe
1 plastenka + 1 brizga
Oral solution bottle (HDPE) 180 ml
Peroralna uporaba plastenka (HDPE) 180 ml
Invented name
Številka EU Izmišljeno ime Jakost
30 mg/ml
30 mg/ml Peroralna raztopina
Package size
Stična ovojnina Vsebina Velikost pakiranja
Source data are, however, no longer available.
Izvorni podatki niso več na voljo.
Jatros Gastroenterol, 1993” (Study S2)”, and
Jatros Gastroenterol, 1993“ (Študija S2), in
Data, however, were not controlled.
Vendar pa rezultati niso bili nadzorovani.
It is not life threatening but can significantly impact the quality of life of patients.
Ni življenjsko nevarno, vendar lahko močno vpliva na kakovost življenja bolnikov.
Symbioflor 2 is currently used for the indications:
Zdravilo Symbioflor 2 se trenutno uporablja za naslednje indikacije:
This relatively benign safety profile was confirmed by post-marketing data.
Ta sorazmerno benigen varnostni profil so potrdili tudi podatki iz obdobja trženja.
The marketing authorisations were granted in Austria in 2000 (renewed on 12 February 2014) and in 2003 in Hungary (HU) respectively.
Dovoljenje za promet z zdravilom je bilo v Avstriji izdano leta 2000 (in podaljšano 12. februarja 2014), na Madžarskem pa leta 2003.
Such a re-analysis in full knowledge of the results carries the risk of introducing bias that can compromise the integrity of a study.
Tovrstna ponovna analiza ob popolnem poznavanju rezultatov prinaša tveganje za vnos pristranskosti, ki lahko ogrozi integriteto študije.
Symbioflor 2 has been marketed in Germany since 1954 and in Austria since 1975.
Zdravilo Symbioflor 2 se v Nemčiji trži od leta 1954, v Avstriji pa od leta 1975.
The findings were consistent across age and gender subgroups.
Izsledki so bili skladni v vseh podskupinah, razdeljenih po starosti in spolu.
The newly defined primary endpoints in this re-evaluation were evaluated with adequate statistical methodology and were strict with regards to treatment success, because only patients completely free of symptoms were counted as “responders”.
Na novo opredeljene primarne opazovane dogodke v tej ponovni oceni so ovrednotili z ustrezno statistično metodologijo, uspeh zdravljenja pa je bil strogo določen, saj so bili kot „odzivni“ upoštevani le bolniki, ki so bili popolnoma brez simptomov.
The CHMP noted that in the clinical development program no data were available for treatment beyond 8 weeks.
Odbor CHMP je opozoril, da v programu kliničnega razvoja ni bilo na voljo podatkov o zdravljenju, ki bi presegalo 8 tednov.
Which species and strains are most beneficial has to be determined individually case by case, and the mechanism of action of probiotics remains speculative.
Katere vrste in sevi so najkoristnejši, je treba ugotoviti posamično, za vsak primer posebej, mehanizem delovanja probiotikov pa ostaja hipotetičen.
Following the rejection of the application, the Marketing Authorisation Holder (MAH) requested to be granted a German National Marketing Authorisation on the basis that an authorisation had already been granted in another country of the European Union (Austria).
Po zavrnitvi vloge je imetnik dovoljenja za promet z zdravilom zaprosil za nemško nacionalno dovoljenje za promet z zdravilom na podlagi dejstva, da je bilo dovoljenje za promet z zdravilom že izdano v drugi državi Evropske unije (Avstriji).
In addition, possible irregularities in the conduct of the study cast doubt over the integrity of the data: for instance, for two centres, the visits for all but one patient occurred in accordance with the study protocol at the exact interval for the whole duration of the study, one of the dates being a public holiday.
Poleg tega morebitne nepravilnosti pri izvedbi študije vzbujajo dvome glede integritete podatkov: na primer pri dveh centrih so potekali obiski vseh bolnikov razen enega v skladu s protokolom študije z natančno enakimi presledki ves čas študije, pri čemer je bil eden izmed datumov praznik.
The analyses showed statistical significant superiority of the active treatment over placebo in almost all endpoints evaluated.
Analize so pokazale statistično značilno superiornost aktivnega zdravljenja v primerjavi s placebom pri skoraj vseh ocenjevanih opazovanih dogodkih.
IBS is a highly prevalent disease and a chronic condition that needs to be managed on a long term basis.
Sindrom razdražljivega črevesa je zelo pogosta bolezen in kronično stanje, ki ga je treba obravnavati dolgoročno.
Symbioflor 2 is available in the European Union (EU) in Austria (AT), Germany (DE) and Hungary (HU) as a medicine not subject to prescription or over-the-counter (OTC).
Zdravilo Symbioflor 2 je v Evropski uniji (EU) na voljo v Avstriji (AT), Nemčiji (DE) in na Madžarskem (HU) kot zdravilo brez recepta.
The MAH did not provide such data and decided to withdraw this indication.
Imetnik dovoljenja za promet z zdravilom teh podatkov ni predložil in se je odločil, da to indikacijo umakne.
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names (Symbioflor 2);
• odbor CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravilo Symbioflor 2 (bakterije Escherichia coli (celice in avtolizat)) in povezana imena (Symbioflor 2);
Symbioflor 2 is composed of 10 different isolates of Escherichia coli which are partly autolysed and partly presented as living bacteria.
Zdravilo Symbioflor 2 sestavlja deset različnih izolatov bakterije Escherichia coli, ki so delno avtolizirani in delno v obliki živih bakterij.
While several centres did not report any responder, the overall results were driven by one centre.
Nekateri centri niso poročali o nobenem odzivnem bolniku, na skupne rezultate pa je v glavnem vplival en sam center.
Finally, the value of an observational study in children and adolescents for substantiating the efficacy of the product in this patient population is limited.
Prav tako je vrednost opazovalne študije pri otrocih in mladostnikih, ki bi podprla učinkovitost zdravila pri tej populaciji bolnikov, omejena.
However, indirect risks associated with the intake of a potentially inefficacious medication for IBS with regards to continued impairment of quality of life and potential consequences regarding work- and health-care-seeking -related behaviour need to be considered.
Vendar pa je treba upoštevati posredna tveganja, povezana z jemanjem potencialno neučinkovitih zdravil za sindrom razdražljivega črevesa, v povezavi s stalno okrnjeno kakovostjo življenja in morebitnimi posledicami pri iskanju dela in zdravstvenih storitev.
When excluding this centre, a statistically significant centre effect was seen and the statistical significance was lost for both co-primary variables, as well as for the physician's global assessment endpoint.
Z izključitvijo tega centra so opazili statistično značilen učinek centra, statistična značilnost pa je bila izgubljena pri obeh sočasnih primarnih spremenljivkah in pri opazovanem dogodku zdravnikove splošne ocene.
Supplementary Integrated Clinical Study Report Final PAZ 9527-5-S2”, of the study conducted in 1988 in Germany entitled “Schaffstein, W. and Burkard, I.: Symbioflor 2 - Eine therapeutische Alternative zur Behandlung des irritablen Kolons.
Končno dodatno celovito poročilo o klinični študiji PAZ 9527-5-S2“, študije, opravljene leta 1988 v Nemčiji z naslovom „Schaffstein, W. in Burkard, I.: Symbioflor 2Eine therapeutische Alternative zur Behandlung des irritablen Kolons.
In Germany, since Symbioflor 2 was placed on the market before the entry into force of the German Drug Law in 1978, Symbioflor 2 had to undergo the renewal procedure according to § 105 German Drug Law in order to achieve the conformity of the authorisation in Germany with the Union legislation.
Ker je bilo zdravilo Symbioflor 2 v Nemčiji dano v promet pred začetkom veljavnosti nemškega zakona o zdravilih leta 1978, je bilo treba dovoljenje za promet z zdravilom v skladu s členom 105 nemškega zakona o zdravilih podaljšati in tako nemško dovoljenje uskladiti z zakonodajo Unije.
The adverse events were generally benign in nature, and mostly restricted to the gastrointestinal tract (such as abdominal pain and nausea) or related to the occurrence of skin efflorescences.
Neželeni učinki so bili na splošno benigni in večinoma omejeni na prebavila (kot sta trebušna bolečina in navzea) ali povezani s pojavom kožnih eflorescenc.
On this basis and considering the absence of new data since the initial marketing authorisation, the CHMP considered changes to the product information to include the information of this review necessary.
Na tej podlagi in z upoštevanjem pomanjkanja novih podatkov od časa prvega dovoljenja za promet z zdravilom je odbor CHMP presodil, da so potrebne spremembe informacij o zdravilu, ki morajo vključevati informacije tega pregleda.
In addition, an ad-hoc expert group was convened on 13 January 2017, where the CHMP requested feedback from experts in the treatment of IBS on specific questions regarding the therapeutic role of Symbioflor 2.
Poleg tega se je 13. januarja 2017 zbrala ad hoc strokovna skupina in odbor CHMP je strokovnjake za zdravljenje sindroma razdražljivega črevesa zaprosil za povratne informacije o določenih vprašanjih glede terapevtske vloge zdravila Symbioflor 2.
• To regulate the immune system (immune-regulation): functional disturbances of the gastrointestinal system (HU).
• uravnavanje imunskega sistema (imunska regulacija): funkcionalne motnje prebavil (HU).
• An observational non-interventional study in 203 children and adolescents conducted between 2007 and 2008 in Germany “Efficacy and tolerability of Symbioflor 2 in children with Irritable Bowel Syndrome”.
• opazovalna, neintervencijska študija pri 203 otrocih in mladostnikih, opravljena med letoma 2007 in 2008 v Nemčiji, „Učinkovitost in prenašanje zdravila Symbioflor 2 pri otrocih s sindromom razdražljivega črevesa“.
On 30 March 2016 Germany triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the benefit-risk balance of Symbioflor 2 in the claimed indications ("functional gastrointestinal disorders'', "irritable bowel syndrome") and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Nemčija je 30. marca 2016 sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor CHMP zaprosila, naj oceni razmerje med tveganji in koristmi zdravila Symbioflor 2 pri predloženih indikacijah („funkcionalne motnje prebavil“, „sindrom razdražljivega črevesa“) ter izda mnenje o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno preklicati ali ukiniti.
Therefore, the CHMP recommends a variation to the terms of the marketing authorisation.
Zato priporoča spremembo pogojev dovoljenja za promet z zdravilom.
In 2005, rather than conducting a new study in line with the “Note for guidance on statistical principles for clinical trials” (CPMP/ICH/363/96) then in force, the MAH decided to perform a post-hoc reevaluation of Study S2, i.e. establishing the definition of the primary hypothesis, the corresponding evaluation plan and the statistical analysis methods in full knowledge of the results.
Leta 2005 se je imetnik dovoljenja za promet zdravilom raje kot za novo študijo v skladu s tedaj veljavnimi „Navodili o statističnih načelih za klinična preskušanja“ (CPMP/ICH/363/96) odločil, da bo izvedel post-hoc ovrednotenje Študije S2, tj. z vzpostavitvijo opredelitve primarne hipoteze, ustreznega načrta vrednotenja in metod za statistično analizo ob popolnem poznavanju rezultatov.
In addition, the CHMP noted that data generated in study S2 have not established the long term efficacy of Symbioflor 2 beyond 8 weeks of treatment.
Poleg tega je odbor CHMP opozoril, da podatki, pridobljeni v Študiji S2, ne dokazujejo dolgoročne učinkovitosti zdravila Symbioflor 2, ki bi trajala več kot 8 tednov zdravljenja.
Proof of the efficacy of Symbioflor 2 in this patient population would have required a prospective, double-blinded, randomized and placebo-controlled trial as per the guideline CPMP/EWP/785/97 in force at the time of the conduct of the study.
Za dokaz učinkovitosti zdravila Symbioflor 2 pri tej populaciji bolnikov bi bilo treba izvesti prospektivno, dvojno slepo, randomizirano in s placebom nadzorovano preskušanje v skladu s smernico CPMP/EWP/785/97, ki je veljala v času izvedbe študije.
In the absence of a run-in phase and specific inclusion criteria, there was also insufficient assurance that the patient population suffered from IBS.
V odsotnosti uvajalne faze in konkretnih vključitvenih meril ni bilo zadostnega zagotovila, da je populacija bolnikov res imela sindrom razdražljivega črevesa.
The evaluation of the results was descriptive and thus did not allow establishing whether the differences in efficacy between Symbioflor 2 and placebo were statistically different and clinically meaningful.
Ovrednotenje rezultatov je bilo opisno in zato ni bilo mogoče ugotoviti, ali so bile razlike v učinkovitosti med zdravilom Symbioflor 2 in placebom statistično značilne in klinično pomembne.
In the re-evaluation report of Study S2 (2005), the endpoints were redefined, combining parameters of a patient-centred assessment of spontaneous symptoms with endpoints based on physical examination by the physician.
V poročilu, v katerem so ponovno ovrednotili Študijo S2 (2005), so ponovno opredelili opazovane dogodke in združili parametre k bolnikom usmerjene ocene spontanih simptomov z opazovanimi dogodki fizičnega pregleda, ki ga je opravil zdravnik.
Based on the review of all available data in the framework of this Article 31 procedure, the CHMP concludes that there are no new elements since the granting of the marketing authorisation for Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names, and therefore the previous conclusion of the national competent authorities on a positive benefit-risk balance remains unchanged.
Na podlagi pregleda vseh razpoložljivih podatkov v okviru tega postopka v skladu s členom 31 odbor CHMP zaključuje, da od izdaje dovoljenja za promet z zdravilom za zdravilo Symbioflor 2 (bakterije Escherichia coli (celice in avtolizat)) in povezana imena ni bilo nobenih novih elementov, zato prejšnji sklep pristojnega nacionalnega organa o pozitivnem razmerju med tveganji in koristmi ostaja nespremenjen.
In general, the CHMP was of the opinion that, although the reporting might have been suboptimal and uncertainties remain with regards to the nature and frequency of the adverse events occurring with Symbioflor 2 in order to fully characterize its safety profile and notably its long term safety profile, the analysis of the safety data did not raise particular concerns.
Na splošno je bil odbor CHMP mnenja, da čeprav poročanje morda ni bilo optimalno in ostajajo negotovosti glede narave in pogostosti neželenih učinkov zdravila Symbioflor 2 pri celoviti opredelitvi njegovega varnostnega profila, predvsem dolgoročnega varnostnega profila, z analizo podatkov o varnosti niso odkrili pomembnih pomislekov.
Given the heterogeneity of the disease and the absence of data, the CHMP asked the MAH to submit evidence to support this indication.
Glede na heterogenost bolezni in odsotnost podatkov je odbor CHMP zaprosil imetnika dovoljenja za promet z zdravilom, naj predloži dokaze v podporo tej indikaciji.
Finally, the CHMP noted that the total number of reports was low, and as per the Weber effect, a decline in reporting of adverse events is likely over time.
Končno je odbor CHMP opozoril, da je skupno število poročil majhno, v skladu z Webrovim učinkom pa se sčasoma lahko pričakuje zmanjšanje poročanja o neželenih učinkih.
Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names (Symbioflor 2) is a probiotic containing living Escherichia coli bacteria, which exist in normal gut flora in humans.
Zdravilo Symbioflor 2 (bakterije Escherichia coli (celice in avtolizat) in povezana imena (Symbioflor 2) je probiotik, ki vsebuje žive bakterije Escherichia coli, ki so del normalne črevesne flore pri ljudeh.
Apart from data on IBS, no controlled or uncontrolled clinical study or literature data are available to assess the efficacy and safety of Symbioflor 2 in the treatment of these diseases.
Razen podatkov o sindromu razdražljivega črevesa ni na voljo podatkov iz nadzorovanih ali nenadzorovanih kliničnih študij ali literature, s katerimi bi lahko ocenili učinkovitost in varnost zdravila Symbioflor 2 pri zdravljenju teh bolezni.
No study was submitted to support the indication in the treatment of functional gastrointestinal disorders.
V podporo indikaciji za zdravljenje funkcionalnih motenj prebavil ni bila predložena nobena študija.
The evaluations presented in the Study Report of Study S2 (1989), based on a primary endpoint of “global evaluation” of efficacy by the investigator at the end of the trial, showed that Symbioflor 2 administered over an 8-week period had better outcomes than placebo on most of the evaluated endpoints.
Ocene, predstavljene v študijskem poročilu o Študiji S2 (1989) na podlagi primarnega opazovanega dogodka „splošna ocena“ učinkovitosti s strani raziskovalca na koncu preskušanja, so pokazale, da so bili izidi večine ocenjevanih opazovanih dogodkov pri jemanju zdravila Symbioflor 2, ki so ga dajali v osemtedenskem obdobju, boljši kot pri jemanju placeba.
Indication in the treatment of irritable bowel syndrome
Indikacija za zdravljenje sindroma razdražljivega črevesa
• The CHMP considered that “functional gastrointestinal disorders” is a heterogeneous group of individual diseases with a wide range of different underlying pathophysiologies and symptoms that require different treatment modalities.
• odbor CHMP je presodil, da so „funkcionalne motnje prebavil“ heterogena skupina posameznih bolezni s širokim razponom različnih osnovnih patofiziologij in simptomov, ki zahtevajo različne načine zdravljenja.
• Considering available safety data from the clinical trial and post-marketing experience with Symbioflor 2, the CHMP came to the conclusion that the demonstrated risks were overall low.
• z upoštevanjem razpoložljivih podatkov o varnosti iz kliničnega preskušanja in izkušenj iz obdobja trženja z zdravilom Symbioflor 2 je odbor CHMP sklenil, da so dokazana tveganja na splošno nizka.
The value of an observational study for substantiating the efficacy of the product in this patient population is limited and therefore the CHMP concluded that this study could not be regarded as adequately supporting the efficacy of Symbioflor 2 in this age group.
Vrednost opazovalne študije pri dokazovanju učinkovitosti zdravila v tej populaciji bolnikov je omejena, zato je odbor CHMP zaključil, da ta študija ne more veljati kot ustrezna podpora za učinkovitost zdravila Symbioflor 2 v tej starostni skupini.
Although Study S2 was conducted before requirements of the current IBS guideline “Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome” (CPMP/EWP/785/97) or the previous CHMP point to consider on IBS came into force, the original protocol of Study S2 neither defined a primary endpoint nor planned for a statistical analysis.
Čeprav je bila Študija S2 opravljena, preden so začele veljati zahteve sedanje smernice za sindrom razdražljivega črevesa z naslovom „Smernice za vrednotenje zdravil za zdravljenje sindroma razdražljivega črevesa“ (CPMP/EWP/785/97) ali argument odbora CHMP, ki ga je treba upoštevati pri sindromu razdražljivega črevesa, prvotni protokol Študije S2 ni niti opredelil primarnega opazovanega dogodka niti ni načrtoval statistične analize.
• The CHMP reviewed all available data from clinical studies, published literature, post-marketing experience, including responses and communications submitted by the MAH in writing, on the efficacy and safety of Symbioflor 2 in their proposed indications and sought as well views of the ad hoc expert group on Symbioflor 2;
• odbor CHMP je pregledal vse razpoložljive podatke iz kliničnih študij, objavljene literature, izkušenj iz obdobja trženja, vključno z odgovori in sporočili, ki jih je pisno predložil imetnik dovoljenja za promet z zdravilom, o učinkovitosti in varnosti zdravila Symbioflor 2 pri predlaganih indikacijah, poleg tega pa je zaprosil tudi za stališča ad hoc strokovne skupine o zdravilu Symbioflor 2;