FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood cholesterol increased, blood urea increased Allergic skin reactions (sometimes severe), including life-threatening skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth, inflammation of the skin, hives, sunburn or severe skin reaction following exposure to light or sun, skin redness and irritation, red or purple discoloration of the skin which may be caused by low platelet count, eczema
Danish: • Allergiske hudreaktioner (undertiden alvorlige), herunder livstruende hudsygdom, der giver smertende blærer og sår på hud og slimhinder, især i munden, betændelse i huden, nældefeber,
English: Inflammation of the sinuses, inflammation of the gums, chills, weakness Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot Low blood sugar, low blood potassium, low sodium in the blood Anxiety, depression, confusion, agitation, inability to sleep, hallucinations Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness Bleeding in the eye
Danish: • Lavt antal, herunder alvorligt, af visse typer røde (sommetider immunrelateret) og/eller hvide blodlegemer (sommetider med feber), lavt antal celler, som kaldes blodplader (trombocytter),
English: Gently mix the contents of the infusion bag.
Danish: Indholdet i infusionsposen omblandes forsigtigt.
English: • A sterile, single use, syringe.
Danish: • Betændelse i gummerne, kulderystelser, svaghed
English: Includes periorbital oedema, lip oedema, and oedema mouth.
Danish: Inkluderer periorbitalt ødem, læbeødem og ødem i munden.
English: Constitution instructions:
Danish: Oversigt over indlægssedlen:
English: If patient response to treatment is inadequate, the dose may be increased by 1 mg/kg steps (or by 50 mg steps if the maximum oral dose of 350 mg was used initially).
Danish: Dosisjustering (børn (2- <12 år) og unge med lav legemsvægt (12-14 år og <50 kg)) Ved utilstrækkeligt behandlingsrespons kan dosis øges i trin på 1 mg/kg (eller 50 mg/trin, hvis den maksimale orale dosis på 350 mg blev anvendt initialt).
English: Write the date of expiry of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 14 days).
Danish: Skriv udløbsdato for den færdigblandede suspension på flaskeetiketten.
English: Package Size
Danish: Paknings-størrelse
English: Medicinal product no longer authorised
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: EU/1/97/045/003 Helicobacter Test INFAI for children of the age 3-11
Danish: EU/1/97/045/003 Helicobacter Test INFAI til børn i alderen 3 - 11 år
English: 50 jars
Danish: 50 beholder
English: 50 jars, as part of a multicomponent kit with breath bags
Danish: 50 beholder, som del af et flerkomponent kit indeholdende indhaleringsbeholdere
English: 1 jar, as part of a multicomponent kit with breath bags
Danish: 1 dåse, som del af et flerkomponent kit indeholdende indhaleringsbeholdere
English: Invented name Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform Indgivelsesvej
English: Packaging
Danish: Emballage Indhold
English: Content
Danish: Særnavn
English: 12 x (1 vial + 1 prefilled syringe + 1 vial adapter with needle + 2 alcohol wipes) (Titration pack)
Danish: 12 x (1 hætteglas + 1 fyldt sprøjte + 1 adapter til hætteglas med kanyle + 2 spritservietter) (titreringspakning)
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration
English: Other information about Ifirmasta:
Danish: Andre oplysninger om Ifirmasta:
English: Ifirmasta irbesartan
Danish: irbesartan
English: This document is a summary of the European public assessment report (EPAR) for Ifirmasta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ifirmasta.
English: The name of the medicine was changed to Ifirmasta on 24 September
Danish: Lægemidlets navn blev ændret til Ifirmasta den 24. september 2009.
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Krka on 1 December 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Irbesartan Krka den 1. december 2008.
English: The full EPAR for Ifirmasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ifirmasta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ifirmasta is a ‘generic medicine'.
Danish: Ifirmasta er et "generisk lægemiddel".
English: What are the benefit and risk of Ifirmasta?
Danish: Hvilken fordel og risiko er der forbundet med Ifirmasta?
English: Previously known as Irbesartan Krka.
Danish: Tidligere kendt som Irbesartan Krka.
English: This means that Ifirmasta is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Danish: Det betyder, at Ifirmasta er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Aprovel.
English: For more information about treatment with Ifirmasta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ifirmasta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ifirmasta.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Ifirmasta skal anvendes.
English: The Committee recommended that Ifirmasta be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ifirmasta.
English: The usual recommended dose of Ifirmasta is 150 mg once a day.
Danish: Den normalt anbefalede dosis af Ifirmasta er 150 mg en gang dagligt.
English: Ifirmasta is a medicine that contains the active substance irbesartan.
Danish: Ifirmasta er et lægemiddel, der indeholder det aktive stof irbesartan.
English: The CHMP concluded that, in accordance with EU requirements, Ifirmasta has been shown to have comparable quality and to be bioequivalent to Aprovel.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Ifirmasta er af sammenlignelig kvalitet og er bioækvivalent med Aprovel.
English: The active substance in Ifirmasta, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Ifirmasta, irbesartan, er en ”angiotensin II-receptorantagonist”, hvilket betyder, at det blokerer virkningen af et hormon i kroppen kaldet angiotensin II.
English: Ifirmasta is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Danish: Ifirmasta anvendes desuden til behandling af nyresygdom hos voksne med hypertension og type 2-diabetes.
English: Why has Ifirmasta been approved?
Danish: Hvorfor blev Ifirmasta godkendt?
English: This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Danish: Dette medfører, at blodtrykket falder, og risikoen for skade forårsaget af forhøjet blodtryk, såsom slagtilfælde, reduceres.
English: Ifirmasta is used in adults who have essential hypertension (high blood pressure).
Danish: Ifirmasta anvendes til voksne med essentiel hypertension (forhøjet blodtryk).
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Danish: Hvis blodtrykket ikke bliver reguleret tilstrækkeligt, kan dosis øges til 300 mg dagligt, eller anden medicin mod forhøjet blodtryk,
English: Because Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Ifirmasta er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Ifirmasta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine.
Danish: Da Ifirmasta er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet.
English: What is Ifirmasta?
Danish: Hvad er Ifirmasta?
English: In patients with hypertension and type 2 diabetes, Ifirmasta is added to some other treatments for hypertension.
Danish: Til patienter med forhøjet blodtryk og type 2-diabetes anvendes Ifirmasta som tillægsbehandling til andre behandlinger af forhøjet blodtryk.
English: What is Ifirmasta used for?
Danish: Hvad anvendes Ifirmasta til?
English: How has Ifirmasta been studied?
Danish: Hvordan blev Ifirmasta undersøgt?
English: How is Ifirmasta used?
Danish: Hvordan anvendes Ifirmasta?
English: How does Ifirmasta work?
Danish: Hvordan virker Ifirmasta?
English: The current annual reporting cycle for periodic safety update reports (PSURs) should be maintained.
Danish: Den løbende årlige periodiske opdaterede sikkerhedsindberetninger (PSUR) cyklus bør opretholdes.
English: Date of first authorisation: 14/04/2011 Date of last renewal: 15/03/2016
Danish: Dato for første tilladelse: 14/04/2011 Dato for sidste fornyelse af tilladelsen: 15/03/2016
English: Each ml of vaccine contains:
Danish: Én ml vaccine indeholder:
English: EXP {month/year} Once opened, use within 10 hours.
Danish: (måned/år) Efter anbrud, brug inden for 10 timer.
English: (*) equivalent to titre prior to inactivation (log10)
Danish: (*) svarende til titer før inaktivering (log10)
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Danish: *(Cyklusværdi (Ct) ≥ 36 med en valideret RT-PCR-metode, som ikke indikerede tilstedeværelse af viralt genom)
English: OTHER INFORMATION Immunological properties
Danish: ANDRE OPLYSNINGER Immunologiske egenskaber
English: ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Danish: ATCvet-kode: QI04AA02 (får) og QI02AA08 (kvæg).
English: 1 year after the second dose.
Danish: 1 år efter anden dosis.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (http://www.ema.europa.eu/)
English: Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte veterinærlægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med de lokale krav.
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIGE ADVARSLER, OM NØDVENDIGT
English: Intervet Nederland B.V. Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652
Danish: Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652
English: Tel.: + 34 986 33 04 00 Fax: + 34 986 33 65 77 czv@czveterinaria.com
Danish: Tlf: + 34 986 33 04 00 Fax: + 34 986 33 65 77 czv@czveterinaria.com
English: 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
Danish: EU/2/11/122/001 flaske à 52 ml EU/2/11/122/002 flaske à 100 ml EU/2/11/122/003 flaske à 252 ml
English: Suspension for injection White or pinkish-white.
Danish: Injektionsvæske, suspension Hvidt eller rosa-hvid.
English: Each ml of vaccine contains: BTV8 antigen 106.5 CCID50
Danish: Én ml vaccine indeholder: BTV8 antigen 106,5 CCID50
English: It lasts not longer than 24 to 48 hours.
Danish: Denne temperaturstigning varer kun mellem 24 og 48 timer.
English: BLUEVAC BTV8 suspension for injection for cattle and sheep
Danish: BLUEVAC BTV8 injektionsvæske, suspension til kvæg og får
English: Vaccinate healthy animals only.
Danish: Vaccinen må kun anvendes til raske dyr.
English: Special warnings for each target species: Vaccinate healthy animals only.
Danish: Særlige advarsler for hver dyreart Vaccinen må kun anvendes til raske dyr.
English: BLUEVAC BTV8 stimulates active immunity against bluetongue virus, serotype 8.
Danish: BLUEVAC BTV8 stimulerer aktiv immunitet mod bluetonguevirus, serotype 8.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: 4.2 Indications for use, specifying the target species Sheep
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Får
English: Can be used during pregnancy in ewes and cows.
Danish: Kan anvendes under drægtighed hos får og køer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (52 ml, 100 ml and 252 ml)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton (52 ml, 100 ml, 252 ml)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton.
Danish: Opbevaringstid efter første åbning af beholderen: 10 timer Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på etiketten/ydre emballage.
English: Cattle from 2.5 months of age: Administer two doses of 4 ml subcutaneously with a 3 week interval.
Danish: Kvæg fra 2,5-månedersalderen: Indgiv to doser på 4 ml subkutant med 3 ugers mellemrum.
English: 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.
Danish: Aktiv immunisering af får fra 2,5-månedsalderen til forebyggelse af viræmi* og til reduktion af kliniske symptomer forårsaget af bluetonguevirus serotype 8.
English: Bluetongue virus inactivated, serotype 8:
Danish: Inaktiveret bluetonguevirus, serotype 8:
English: Special precautions for use in animals
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Ikke relevant
English: Pharmacotherapeutic group: Bluetongue virus vaccines, inactivated.
Danish: Farmakoterapeutisk gruppe: Vacciner mod bluetonguevirus, inaktiveret.
English: Lactation: There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Danish: Laktation: Anvendelse af vaccinen hos diegivende får og køer har ingen negativ indvirkning på mælkeudbyttet.
English: Each ml of vaccine contains: Bluetongue virus inactivated, serotype 8
Danish: Én ml vaccine indeholder: Inaktiveret bluetonguevirus, serotype 8
English: Sheep from 2.5 months of age: Administer two doses of 2 ml subcutaneously with a 3 week interval.
Danish: Får fra 2,5-månedersalderen: Indgiv to doser på 2 ml subkutant med 3 ugers mellemrum.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ikke relevant
English: Box of 1 bottle of 52 ml Box of 1 bottle of 100 ml Box of 1 bottle of 252 ml.
Danish: 1 flaske à 52 ml 1 flaske à 100 ml 1 flaske à 252 ml
English: Pregnancy: Can be used during pregnancy in ewes and cows.
Danish: Drægtighed Kan anvendes under drægtighed hos får og køer.
English: Duration of immunity: 1 year after the second dose.
Danish: Immuniteten indtræder: 31 dage efter anden dosis.
English: Cardboard box with 1 bottle containing either 126 sheep doses or 63 cattle doses (252 ml).
Danish: Æske med 1 flaske indeholdende enten 26 fåredoser eller 13 kvægdoser (52 ml) Æske med 1 flaske indeholdende enten 50 fåredoser eller 25 kvægdoser (100 ml) Æske med 1 flaske indeholdende enten 126 fåredoser eller 63 kvægdoser (252 ml)
English: 20 days after the second dose.
Danish: Immuniteten indtræder: 20 dage efter anden dosis.
English: Pharmacotherapeutic group: bluetongue virus vaccine, inactivated.
Danish: Farmakoterapeutisk gruppe: Vaccine mod bluetonguevirus.
English: 100 ml 252 ml
Danish: Flaske à 100 ml Flaske à 252 ml
English: CZ Veterinaria, S.A. 36400 Porriño SPAIN
Danish: CZ Veterinaria, S.A. 36400 Porriño SPANIEN
English: CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño SPAIN
Danish: CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño SPANIEN
English: 1 bottle + 1 syringe
Danish: 1 flaske + 1 sprøjte
English: Oral solution bottle (HDPE) 180 ml
Danish: Oral anvendelse Flaske (HDPE) 180 ml
English: 30 mg/ml
Danish: 30 mg/ml Oral opløsning
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administrationsmåde Emballage
English: Data, however, were not controlled.
Danish: Dataene var dog ikke kontrolleret.
English: It is not life threatening but can significantly impact the quality of life of patients.
Danish: Den er ikke livstruende, men den kan have væsentlig indflydelse på patienternes livskvalitet.
English: Symbioflor 2 is currently used for the indications:
Danish: Symbioflor 2 anvendes i øjeblikket til indikationerne:
English: Source data are, however, no longer available.
Danish: Kildedataene er dog ikke længere tilgængelige.
English: The findings were consistent across age and gender subgroups.
Danish: Fundene var konsistente på tværs af alders- og kønsundergrupper.
English: Jatros Gastroenterol, 1993” (Study S2)”, and
Danish: Jatros Gastroenterol, 1993" (S2-undersøgelsen), og
English: This relatively benign safety profile was confirmed by post-marketing data.
Danish: Denne relativt gunstige sikkerhedsprofil blev bekræftet af data efter markedsføringen.
English: Symbioflor 2 has been marketed in Germany since 1954 and in Austria since 1975.
Danish: Symbioflor 2 har været markedsført i Tyskland siden 1954 og i Østrig siden 1975.
English: The marketing authorisations were granted in Austria in 2000 (renewed on 12 February 2014) and in 2003 in Hungary (HU) respectively.
Danish: Der blev givet markedsføringstilladelse i Østrig i 2000 (fornyet den 12. februar 2014) og Ungarn (HU) i 2003.
English: IBS is a highly prevalent disease and a chronic condition that needs to be managed on a long term basis.
Danish: IBS er en hyppigt forekommende sygdom og en kronisk tilstand, der skal håndteres langsigtet.
English: 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).
Danish: Efter afslaget på ansøgningen anmodede indehaveren af markedsføringstilladelsen (MAH) om udstedelse af en tysk national markedsføringstilladelse, under henvisning til at der allerede var givet tilladelse i et andet EU-land (Østrig).
English: Such a re-analysis in full knowledge of the results carries the risk of introducing bias that can compromise the integrity of a study.
Danish: En sådan reanalyse med fuldt kendskab til resultaterne indebærer en risiko for at indføre bias, som kan kompromittere en undersøgelses integritet.
English: No adverse events were reported in the observational study conducted in children and adolescents.
Danish: Der blev ikke rapporteret nogen uønskede hændelser i observationsundersøgelsen hos børn og unge.
English: Therefore, the CHMP recommends a variation to the terms of the marketing authorisation.
Danish: CHMP anbefaler derfor, at betingelserne for markedsføringstilladelsen ændres.
English: Which species and strains are most beneficial has to be determined individually case by case, and the mechanism of action of probiotics remains speculative.
Danish: Det skal fastlægges individuelt i de enkelte tilfælde, hvilke arter og stammer der er mest gavnlige, og probiotikas virkningsmekanisme er stadig spekulativ.
English: The analyses showed statistical significant superiority of the active treatment over placebo in almost all endpoints evaluated.
Danish: Analyserne viste den aktive behandlings statistisk signifikante superioritet i forhold til placebo i næsten alle de evaluerede endepunkter.
English: Finally, the value of an observational study in children and adolescents for substantiating the efficacy of the product in this patient population is limited.
Danish: Endelig er værdien af en observationsundersøgelse hos børn og unge for at fastslå lægemidlets virkning hos denne patientpopulation begrænset.
English: While several centres did not report any responder, the overall results were driven by one centre.
Danish: Mens flere centre ikke rapporterede nogen respondenter, var der ét center, som havde indflydelse på de samlede resultater.
English: 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”.
Danish: De nye endepunkter i denne reevaluering blev vurderet med en passende statistisk metode og var strenge med hensyn til behandlingssucces, eftersom kun fuldstændigt symptomfrie patienter blev talt med som "respondenter".
English: In the absence of a run-in phase and specific inclusion criteria, there was also insufficient assurance that the patient population suffered from IBS.
Danish: Da der manglede en indkøringsfase og specifikke inklusionskriterier, var der også utilstrækkelige garantier for, at patientpopulationen led af IBS.
English: The CHMP noted that in the clinical development program no data were available for treatment beyond 8 weeks.
Danish: CHMP bemærkede, at der i det kliniske udviklingsprogram ikke var nogen data tilgængelige om behandling i længere tid end 8 uger.
English: 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.
Danish: Endvidere gav mulige uregelmæssigheder i undersøgelsens gennemførelse grund til at tvivle på dataenes integritet: F.eks. var der to centre, hvor besøgene for alle patienter undtagen én fandt sted i overensstemmelse med undersøgelsesprotokollen i det nøjagtige interval for hele undersøgelsens varighed, selv om en af datoerne var en helligdag.
English: The MAH did not provide such data and decided to withdraw this indication.
Danish: Indehaveren af markedsføringstilladelsen fremsendte ikke sådanne data og besluttede at trække denne indikation tilbage.
English: 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.
Danish: Eftersom Symbioflor 2 blev markedsført i Tyskland inden ikrafttrædelsen af den tyske lægemiddellov i 1978, var Symbioflor 2 genstand for en fornyelsesprocedure i henhold til § 105 i den tyske lægemiddellov for at opnå overensstemmelse af tilladelsen i Tyskland med EU-lovgivningen.
English: 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.
Danish: Desuden blev der indkaldt en ad hoc-ekspertgruppe den 13. januar 2017, hvor CHMP bad om feedback fra eksperter i behandling af IBS med hensyn til specifikke spørgsmål, der vedrørte den terapeutiske virkning af Symbioflor 2.