natgillin/translations-raw huggingface dataset:
The current annual reporting cycle for periodic safety update reports (PSURs) should be maintained. 
Potrebno je ohraniti letni cikel rednih posodobljenih poročil o varnosti zdravila (PSUR).
Date of first authorisation: 14/04/2011 Date of last renewal: 15/03/2016 
Datum pridobitve: 14/04/2011 Datum podaljšanja dovoljenja za promet: 15/03/2016
Each ml of vaccine contains: 
En ml cepiva vsebuje:
a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control and/or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. 
a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
1 dose per year. 
1 odmerek letno.
Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine. 
Občasno lahko prisotnost maternalnih protiteles pri ovcah minimalne priporočene starosti vpliva na zaščito, ki jo zagotavlja cepivo.
Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/).
Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation. 
Vsak program ponovnega cepljenja mora odobriti pristojni organ ali odgovorni veterinar ob upoštevanju lokalnih epidemioloških razmer.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle). 
Oznake ATC vet: QI04AA02 (ovce) in QI02AA08 (govedo).
Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 
Vsako neuporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo pri teh zdravilih, je treba odstraniti v skladu z lokalnimi zahtevami.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Ni podatkov o varnosti ter učinkovitosti uporabe tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na plastenki/kartonski škatli.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu). 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/).
OTHER INFORMATION Immunological properties 
DRUGE INFORMACIJE Imunološke lastnosti
The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle). 
Varnost in učinkovitost cepiva nista bili ugotovljeni pri plemenskih samcih (ovce in govedo).
In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National competent authorities on the current vaccination policies against bluetongue virus (BTV). 
Pri tej kategoriji živali lahko cepivo uporabimo le na podlagi ocene razmerja korist-tveganje odgovornega veterinarja in/ali pristojnega nacionalnega organa, odvisno od veljavne politike cepljenja proti virusu bolezni modrikastega jezika (BTV).
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. 
Ob uporabi cepiva pri drugih domačih in divjih vrstah prežvekovalcev, ki jih ogroža okužba, je potrebna previdnost; pred množičnim cepljenjem je priporočljivo testno cepljenje manjšega števila živali.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
- pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
Special warnings for each target species: Vaccinate healthy animals only. 
Posebna opozorila za vsako živalsko vrsto Cepite samo zdrave živali.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 
*(ciklična vrednost (Ct) ≥ 36 pri potrjeni metodi RT-PCR, kar kaže, da virusni genom ni prisoten) Nastop imunosti:
It lasts not longer than 24 to 48 hours. 
Povišana telesna temperatura traja od 24 do 48 ur.
Temporary local reactions can occur very rarely at the injection site in the form of a nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful. 
Zelo redko se pojavijo začasne lokalne reakcije na mestu injiciranja v obliki bule premera 0,5 do 1 cm pri ovcah in 0,5 do 3 cm pri govedu, ki pa izgine najkasneje v 14 dneh in ki je lahko boleča.
Tel.: + 34 986 33 04 00 Fax: + 34 986 33 65 77 czv@czveterinaria.com 
Tel: + 34 986 33 04 00 Faks: + 34 986 33 65 77 czv@czveterinaria.com
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) 
*(ciklična vrednost (Ct) ≥ 36 pri potrjeni metodi RT-PCR, kar kaže, da virusni genom ni prisoten)
EU/2/11/122/001 bottle of 52 ml EU/2/11/122/002 bottle of 100 ml EU/2/11/122/003 bottle of 252 ml 
EU/2/11/122/001 plastenka z 52 ml EU/2/11/122/002 plastenka s 100 ml EU/2/11/122/003 plastenka z 252 ml
Occasionally a slight increase of the temperature (0.5 ºC - 1.0 ºC) is observed for 24-48 hours after the administration of a double dose of the vaccine. 
Občasno je mogoče opaziti blago povišanje telesne temperature (0,5 ºC-1,0 ºC), ki traja 24-48 ur po dajanju dvojnega odmerka cepiva.
No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies. 
Na voljo ni nobenih informacij o uporabi cepiva pri seropozitivnem govedu niti pri govedu z maternalnimi protitelesi.
BLUEVAC BTV8 suspension for injection for cattle and sheep 
BLUEVAC BTV8 suspenzija za injiciranje za ovce in govedo
Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections) 
tiomersal fosfatna pufrska fiziološka raztopina (natrijev klorid, dinatrijev fosfat in kalijev fosfat, voda za injekcije)
Each ml of vaccine contains: BTV8 antigen 106.5 CCID50 
En ml cepiva vsebuje: antigen BTV8 106,5 CCID50
4.2 Indications for use, specifying the target species Sheep 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Ovce
(*) equivalent to titre prior to inactivation (log10) 
(*)enakovredno titru pred inaktivacijo (log 10)
(*)equivalent to titre prior to inactivation (log10) 
(*) enakovredno titru pred inaktivacijo (log 10)
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that: 
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje, uvoz/vnos,
An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle. 
NEŽELENI UČINKI Povprečno povišanje telesne temperature, ki variira med 0,5 in 1,0 °C, je pogosta reakcija pri ovcah in govedu.
1 year after the second dose. 
1 leto po drugem odmerku.
Suspension for injection White or pinkish-white. 
Bela ali rožnato-bela.
31 days after the second dose. 
31 dni po drugem odmerku.
Loss of appetite can occur in very rare cases. 
V zelo redkih primerih lahko pride tudi do izgube teka.
20 days after the second dose. 
20 dni po drugem odmerku.
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.