natgillin/translations-raw huggingface dataset:
GRANUPAS indeholder para-aminosalicylsyre, der anvendes i kombination med andre lægemidler hos voksne og børn over 28 dage til behandling af tuberkulose i tilfælde af resistens eller intolerans over for andre behandlinger. 
GRANUPAS contains para-aminosalicylic acid which is used in adults and children aged 28 days and older to treat resistant tuberculosis in combination with other medicines, in cases of resistance or intolerability with other treatments.
GRANUPAS er et enteropræparat, hvis syrebestandige coating beskytter det mod nedbrydning i ventriklen og dermed forhindrer dannelse af meta-aminophenol (et kendt hepatotoksisk stof). 
GRANUPAS is a gastro-resistant preparation and, therefore, the acid-resistant coating of the granules protects against degradation in the stomach therefore preventing the formation of meta-aminophenol (a known hepatotoxin).
Para-aminosalicylsyre og dets metabolitter udskilles ved glomerulær filtration og tubulær sekretion. 
Para-aminosalicylic acid and its metabolites are excreted by glomerular filtration and tubular secretion.
• metalsmag, 
• metallic taste,
• Tilsæt indholdet i brevet til et glas tomat- eller appelsinjuice. 
• Add the contents of the sachet to a drink of tomato or orange juice.
Svær nyresygdom. 
Severe renal disease.
Kontakt lægen eller apotekspersonalet, før du tager GRANUPAS: 
Talk to your doctor or pharmacist before taking GRANUPAS
GRANUPAS bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception. 
GRANUPAS is not recommended during pregnancy and in women of childbearing potential not using contraception.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE EMBALLAGER BREV 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
Samtidig administration af para-aminosalicylsyre og ethionamid kan forstærke bivirkningerne af paraaminosalicylsyre, hovedsagelig de gastrointestinale virkninger, herunder ikterus, hepatitis, kvalme, opkastning, diarré, abdominalsmerter eller anoreksi. 
Co-administration of para- aminosalicylic acid and ethionamide may intensify adverse reactions of para-aminosalicylic acid, mainly the gastrointestinal effects, including jaundice, hepatitis, nausea, vomiting, diarrhoea, abdominal pain or anorexia.
Mediantiden til maksimum var 6 timer med variationsbredde 1,5 til 24 timer, og det gennemsnitlige maksimum var 20 µg/ml med variationsbredde 9 til 35 µg/ml: En koncentration på 2 µg/ml blev opretholdt i gennemsnitligt otte timer med variationsbredde 5 til 9,5, og en koncentration på 1 µg/ml blev opretholdt i gennemsnitligt 8,8 timer med variationsbredde 6 til 11,5 timer. 
In a single dose (4 grams) pharmacokinetic study in healthy adult volunteers (N=11) the initial time to a 2 µg/mL serum level of aminosalicylic acid was 2 hours with a range of 45 minutes to 24 hours; the median time to peak was 6 hours with a range of 1.5 to 24 hours; the mean peak level was 20 µg/mL with a range of 9 to 35µg/mL: a level of 2 µg/mL was maintained for an average of 8 hours with a range of 5 to 9.5 a level of 1 µg/mL was maintained for an average of 8.8 hours with a range of 6 to 11.5 hours.
Para-aminosalicylsyre kan nedsætte den gastrointestinale absorption af digoxin ved at hæmme absorptionen fra tarmcellerne. 
Para-aminosalicylic acid may decrease the gastrointestinal absorption of digoxin, by inhibiting the absorption function of intestinal cells.
Malabsorptionssyndrom*, ulcus pepticum, gastrointestinal blødning, ikterus, metalsmag 
Malabsorption syndrome*, peptic ulcer, gastrointestinal bleeding, jaundice, metallic taste.
Hypothyroidism i HIV-smittede patienter er en meget almindelig hændelse og optræder i ≥1/10 personer, især når PAS administreres med ethionamid/prothionamid. 
Hypothyroidism in HIV co-infected patients is a very common event and occurs in ≥ 1/10 subjects, particularly when para-aminosalicylic acid is administered with ethionamide/prothionamide.
Ud fra litteratur cases, kan para-aminosalicylsyre være forbundet med en øget risiko for hypothyreoidisme hos HIV-smittede patienter. 
Para-aminosalicylic acid may be associated with an increased risk of hypothyroidism in HIV coinfected patients.
Hypotyreoidism* 
Hypothyroidism*.
Indholdet i brevet tilsættes et glas appelsin- eller tomatjuice. 
The contents of the sachet should be added to a glass of orange or tomato juice.
Pakningsstørrelse: 30 breve. 
Pack size of 30 sachets.
Det aktive stof er para-aminosalicylsyre. 
The active substance is para-aminosalicylic acid.
• Drys granulatet på æblemos eller yoghurt. 
• Sprinkle the granules onto apple sauce or yogurt.
Para-aminosalicylsyre minder i sin virkningsmekanisme om sulfonamiderne ved at konkurrere med paraaminobenzoesyre (PABA) om dihydropteroat syntetase (DHP), der er et nøgleenzym i biosyntesen af folater. 
The mechanism of action of para-aminosalicylic acid resembles the sulfonamides, competing with paraminobenzoic acid (PABA) for dihydropteroate synthetase (DHP), a key enzyme in the biosynthesis of folates.
GRANUPAS anbefales ikke under graviditet og må kun bruges, hvis din læge tilråder det. Du må ikke amme, mens du tager GRANUPAS. 
GRANUPAS is not recommended during pregnancy and should only be used if advised by your physician.
Enterogranulat Granulatet består af små, bleggule/lysebrune granula med en diameter på ca. 1,5 mm. 
Gastro-resistant granules The granules are small off white/ light brown coloured approximately 1.5 mm diameter.
De øvrige indholdsstoffer er kolloid silica, methacrylsyre-ethylacrylat copolymer (1:1) dispersion 30 %, hypromellose, mikrokrystallinsk cellulose, talcum. 
The other ingredients are silica, colloidal hydrated, dibutyl sebacate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent, hypromellose, cellulose, microcrystalline, talc.
Para-aminosalicylsyre fordeles i en række væv og kropsvæsker, herunder lunger, nyrer, lever og peritonealvæske. 
Para-aminosalicylic acid is distributed in various tissues and fluids including the lungs, kidneys, liver and peritoneal fluid.
Slug granulatet helt. 
Swallow the granules whole.
Hvis du har taget for meget GRANUPAS 
If you take more GRANUPAS than you should
• Digoxin (mod hjertesygdom) • Diphenhydramin (mod overfølsomhedsreaktioner). 
• Diphenylhydramine (for allergic reactions)
Let til moderat nedsat nyrefunktion 
Mild to moderate renal impairment
• destruktion af leverceller, 
• destruction of liver cells
Det skal du vide, før du begynder at tage GRANUPAS Tag ikke GRANUPAS: 
What you need to know before you take GRANUPAS Do not take GRANUPAS
Malabsorptionssyndrom 
Malabsorption syndrome
Para-aminosalicylsyre påvirker kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner. 
Para-aminosalicylic acid has negligible influence on the ability to drive and use machines.
Det fuldstændige syndrom består i steatoré, abnorm røntgen af tyndtarmen, villusatrofi, nedsat kolesterol og nedsat D-xylose og jernabsorption. 
The complete syndrome includes steatorrhoea, an abnormal small bowel pattern on x-ray, villus atrophy, depressed cholesterol, reduced D-xylose and iron absorption.
Ved behandling med para-aminosalicylsyre kan der udvikles malabsorptionssyndrom, der dog sædvanligvis ikke er fuldstændigt. 
A malabsorption syndrome can develop in patients on para-aminosalicylic acid, but is usually not complete.
Ud fra metaboliseringsvejen for paraaminosalicylsyre forventes ingen nævneværdig lægemiddelinteraktion. 
Given the metabolic pathway of para-aminosalicylic acid no significant drug interaction is anticipated.
Para-aminosalicylsyre acetyleres i leveren til den inaktive metabolit N-acetyl-para-aminosalicylsyre, der er uden bakteriostatisk aktivitet. 
Para-aminosalicylic acid is acetylated in the liver and converted into the inactive metabolite, N-acetylpara-aminosalicylic acid which is devoid of bacteriostatic activity.
Blod og lymfesystem Meget sjælden Trombocytopeni, purpura, leukopeni, anæmi, methæmoglobinæmi, agranulocytose 
Very rare Thrombocytopenia, purpura, leukopenia, anemia, methemoglobinemia, agranulocytosis.
Sådan skal du tage GRANUPAS 
How to take GRANUPAS
• hvis du er allergisk over for para-aminosalicylsyre eller et af de øvrige indholdsstoffer i 
• if you are allergic to para-aminosalicylic acid or any of the other ingredients of this medicine (listed in section 6).
Forhøjede blodværdier af alkalisk fosfatase og transaminaser, vægttab 
Increased blood alkaline phosphatase, transaminases, weight loss.
Der foreligger ingen data om indvirkning af para-aminosalicylsyre på fertiliteten. 
There is no evidence available on the effect of para-aminosalicylic acid on fertility.
Der er ingen eller utilstækkelige data fra anvendelse af para-aminosalicylsyre til gravide kvinder.. 
There are no or limited amount of data from the use of para-aminosalicylic acid in pregnant women.
GRANUPAS må ikke anvendes under amning. 
GRANUPAS should not be used during breast-feeding.
• blød afføring, 
• soft stools,
Ved samtidig behandling med digoxin bør serumdigoxin-niveauet overvåges. 
Serum digoxin levels should be monitored in patients on concomitant therapy.
Brug af anden medicin sammen med GRANUPAS 
Other medicines and GRANUPAS
Meget sjældne bivirkninger (forekommer hos mindre end 1 ud af 10 000 behandlede): 
Very rare side effects (may affect less than 1 in 10,000 people):
Abdominalsmerter, opkastning, kvalme, oppustethed, diarré, blød afføring 
Common abdominal pain, vomiting, nausea, bloating, diarrhea, soft stools.
Enterocoatingen beskytter granulatet, så absorptionen først begynder, når det forlader ventriklen. 
Because the granules are protected by an enteric coating, absorption does not commence until they leave the stomach.
Granulatet vil ikke blive opløst, men hvis granulatet synker til bunds, kan det opslæmmes ved at svinge juicen rundt i glasset. 
They will not dissolve, but swirling the juice in the glass will help re-suspend the granules if they sink.
Kalibreret måleske 
Calibrated measuring spoon
En enkeltdosisundersøgelse viste en plasmahalveringstid på 1,62±0,85 h af para-aminosalicylsyre, administreret som GRANUPAS. 
In a single dose study the plasma half-life of para-aminosalicylic acid administered as GRANUPAS was 1.62 ± 0.85 h.
Må ikke tygges eller knuses. 
Do not chew or crush.
Brug ikke lægemidlet, hvis du bemærker, at brevene er opsvulmede, eller hvis granulatet er mørkebrunt eller violet. 
Do not use this medicine if you notice the sachets are swollen or if the granules are dark brown or purple.
• Brug ikke brevet, hvis det er svulmet op, eller hvis granulatet har mistet sin lysebrune farve. 
• Do not use the sachet if it is swollen or the granules have lost their light brown colour.
Almindelige bivirkninger (forekommer hos mere end 1 ud af 100 behandlede): 
Common side effects (may affect more than 1 in 100 people):
Svimmelhed, vestibulært syndrom 
Common Giddiness, vestibular syndrome.
Hvis du oplever bivirkninger, skal du sige det til lægen eller på apoteket. 
If you get any side effects, talk to your doctor or pharmacist.
De hyppigste bivirkninger vedrører mave-tarmsystemet. 
Most frequent adverse reactions were related to the gastrointestinal system.
Kutan hypersensitivitet, hududslæt 
Common Cutaneous hypersensitivity, skin rash.
Ved svær nyresygdom vil der ske ophobning af den inaktive acetylmetabolit af para-aminosalicylsyre. 
Patients with severe renal disease will accumulate the inactive acetyl metabolite of paraaminosalicylic acid.
• nedsat antal røde blodlegemer, 
• reduction in numbers of red blood cells,
Meget sjælden Senesmerter, hovedpine, synsforstyrrelser, perifer neuropati, svimmelhed 
Very rare Tendon pain, headache, visual abnormalities,
• problemer med skjoldbruskkirtlen*, 
• thyroid gland problems*,
• nedsat antal hvide blodlegemer, 
• reduction in numbers of white blood cells,
Sjældne bivirkninger (forekommer hos mere end 1 ud af 10 000 behandlede): 
Rare side effects (may affect more than 1 in 10,000 people):
Absorptionen af vitamin B12 kan nedsættes af para-aminosalicylsyre, så der efter depletion optræder klinisk betydningsfulde abnormiteter af erytrocytterne. 
Vitamin B12 absorption may be reduced by para-aminosalicylic acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance of vitamin B12.
Indlægsseddel: Information til patienten GRANUPAS, enterogranulat, 4 g para-aminosalicylsyre 
Package leaflet: Information for the patient GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
• nedsat antal blodplader, 
• reduction in blood platelets,
• kvalme, 
• nausea,
Hos kaniner havde natriumaminosalicylat ingen virkninger på den embryoføtale udvikling. 
In the rabbit, sodium aminosalicylate had no effects on embryofoetal development; however, the doses evaluated were below those proposed clinically.
Der er ikke udført interaktionsundersøgelser ved co-administration af antiretrovirale midler og paraaminosalicylsyre til patienter med hiv-infektion. 
No drug interaction studies have been conducted in patients with HIV infection taking antiretroviral agents and para-aminosalicylic acid.
Lægemidlet er et lysebrunt enterogranulat i breve. 
This medicine is presented as light brown gastro-resistant granules in sachets.
Brevet bør ikke bruges, hvis det er svulmet op eller hvis granulatet har mistet sin lysebrune farve og er blevet mørkebrunt eller violet. 
The sachet should not be used if it is swollen or if the granules have lost their light brown colour, and are turning dark brown or purple.
75011 Paris Frankrig 
172 rue de Charonne 75011 Paris France
Silica, kolloid 
Silica, colloidal hydrated
• vægttab, 
• dizziness,
Enterogranulat 30 breve 
Gastro-resistant granules 30 sachets
Pakningsstørrelser og yderligere oplysninger 
How to store GRANUPAS Contents of the pack and other information
Hypoglykæmi 
Hypothyroidism
Hepatitis 
Hepatic toxicity
• rødme eller hududslæt, 
• skin redness or rash,
Hvert brev indeholder 4 g para-aminosalicylsyre. 
Each sachet contains 4 g of para-aminosalicylic acid.
GRANUPAS, enterogranulat, 4g para-aminosalicylsyre Oral anvendelse 
GRANUPAS 4g gastro-resistant granules para aminosalicylic acid Oral use
Der foreligger utilstrækkelige data for virkningen af para-aminosalicylsyre på det ammede barn. 
There is insufficient information on the effects of para-aminosalicylic acid in newborns/infants..
GRANUPAS, enterogranulat, 4 g para-aminosalicylsyre 
GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
Hvert brev indeholder 4 g para-aminosalicylsyre 
Each sachet contains 4 g of para-aminosalicylic acid
Der bør udvises forsigtighed ved anvendelse af para-aminosalicylsyre hos patienter med nedsat leverfunktion. 
Para-aminosalicylic acid should be used with caution in patients with hepatic impairment.
Advarsel: Må ikke bruges, hvis brevet er svulmet op, eller hvis granulatet har mistet sin lysebrune farve og er mørkebrunt eller violet. 
Warning: Do not use if sachet is swollen or the granules have lost their light brown colour and are dark brown or purple.
Hvert brev enterogranulat indeholder 4 g para-aminosalicylsyre. 
Each sachet of gastro-resistant granules contains 4 g of para-aminosalicylic acid.
Fald i protrombin, cytolyse af levervævet. 
Decreased prothrombine level, hepatocytolysis.
• mavesår, 
• headache,
Sikkerheden og effekten af GRANUPAS til nyfødte er ikke blevet påvist. 
The safety and efficacy of para-aminosalicylic acid in neonates have not been established.
• opkastning, 
• vomiting,
Det skal du vide, før du begynder at tage GRANUPAS Sådan skal du tage GRANUPAS Bivirkninger 
What GRANUPAS is and what it is used for What you need to know before you take GRANUPAS How to take GRANUPAS
• forhøjede leverenzymer, 
• elevated liver enzymes,
Ved indgivelsen må granulatet derfor kun iblandes i et surt fødemiddel, der beskytter den syrebestandige coating. 
Care must be taken in the administration of these granules to protect the acid-resistant coating by maintaining the granules in an acidic food during dosage administration.
• Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger. 
• If you get any side effects, talk to your doctor or pharmacist.
Udseende og pakningsstørrelser 
What GRANUPAS looks like and contents of the pack
GRANUPAS, enterogranulat, 4 g 
GRANUPAS 4 g gastro-resistant granules
Vaginal anvendelse blisterpakning (PVC/PE) 
Vaginal use blister (PVC/PE)
28 vagitorier + 6 applikatorer 
28 pessaries + 6 applicators
Vagitorie 
Intrarosa
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pantoloc Control den 12. juni 2009. 
The European Commission granted a marketing authorisation valid throughout the EU for Pantoloc Control on 12 June 2009.
Den fuldstændige EPAR for Pantoloc Control findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Pantoloc Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den anbefalede dosis Pantoloc Control er én tablet én gang dagligt, indtil symptomerne forsvinder. 
The recommended dose of Pantoloc Control is one tablet once a day until symptoms have stopped.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pantoloc Control. 
This is a summary of the European public assessment report (EPAR) for Pantoloc Control.
Det anvendes til langtidsbehandling og anvendes desuden til behandling af et større felt af gastrointestinale sygdomme (lidelser i tarmene) end Pantoloc Control. 
It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Pantoloc Control.
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 anvendelsesbetingelserne for Pantoloc Control. 
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 Pantoloc Control.
Hvis du ønsker yderligere oplysninger om behandling med Pantoloc Control, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Pantoloc Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
De hyppigste bivirkninger ved Pantoloc Control (som optræder hos omkring 1 ud af 100 patienter) er diarré og hovedpine. 
The most common side effects with Pantoloc Control (seen in around 1 patient in 100) are diarrhoea and headache.
Pantoloc Control må ikke anvendes af patienter, der er overfølsomme (allergiske) over for pantoprazol, soja eller andre af indholdsstofferne. 
Pantoloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Pantoloc Control anvendes til korttidsbehandling af symptomer på syrerefluks hos voksne. 
Pantoloc Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Pantoloc Control er et lægemiddel, der indeholder det aktive stof pantoprazol. 
Pantoloc Control is a medicine that contains the active substance pantoprazole.
CHMP konkluderede derfor, at fordelene ved Pantoloc Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pantoloc Control. 
The CHMP therefore decided that Pantoloc Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det aktive stof i Pantoloc Control, pantoprazol, er en protonpumpehæmmer. 
The active substance in Pantoloc Control, pantoprazole, is a proton pump inhibitor.
Pantoloc Control pantoprazol 
Pantoloc Control pantoprazole
Pantoloc Control svarer til et referencelægemiddel ved navn Pantoloc, som allerede er godkendt i Den Europæiske Union (EU). 
Pantoloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantoloc.
Referencelægemidlet Pantoloc udleveres kun efter recept. 
The reference medicine, Pantoloc, is only available with a prescription.
CHMP var også af den opfattelse, at adgangen til Pantoloc Control uden lægelig overvågning, baseret på erfaringerne med anvendelsen af pantoprazol, er passende. 
It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of Pantoloc Control without medical supervision is appropriate.
Andre oplysninger om Pantoloc Control: 
Other information about Pantoloc Control
Hvilken risiko er der forbundet med Pantoloc Control? 
What is the risk associated with Pantoloc Control?
Den fuldstændige liste over de indberettede bivirkninger ved pantoprazol fremgår af indlægssedlen. 
For the full list of all side effects reported with Pantoloc Control, see the package leaflet.
Hvorfor blev Pantoloc Control godkendt? 
Why has Pantoloc Control been approved?
Hvordan blev Pantoloc Control undersøgt? 
How has Pantoloc Control been studied?
Hvad er Pantoloc Control? 
What is Pantoloc Control?
Hvad anvendes Pantoloc Control til? 
What is Pantoloc Control used for?
Hvilken fordel viser undersøgelserne, at der er ved Pantoloc Control? 
What benefit has Pantoloc Control shown during the studies?
Hvordan anvendes Pantoloc Control? 
How is Pantoloc Control used?
Hvordan virker Pantoloc Control? 
How does Pantoloc Control work?
Den 25. september 2013 
25 September 2013
Referencemedlemsstaten var Frankrig, og der var 12 berørte medlemsstater: Østrig, Belgien, Danmark, Tyskland, Grækenland, Irland, Italien, Luxembourg, Portugal, Slovenien, Spanien og Det Forenede Kongerige. 
The reference Member State was France and 12 concerned Member States were involved: Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom.
Den endelige udtalelse blev den 25. september 2013 omarbejdet til en beslutning af EuropaKommissionen. 
The final opinion was converted into a Decision by the European Commission on 25 September 2013.
Type II-ændringsproceduren (FR/V/0201/002/II/006) blev indledt den 16. maj 2012. 
The type II variation procedure (FR/V/0201/002/II/006) started on 16 May 2012.
Dag 60 af proceduren i CMD(v) var den 14. marts 2013, og da der ikke var enighed, blev proceduren indbragt for CVMP. 
Day 60 of the CMD(v) procedure was on 14 March 2013, and since there was no agreement the procedure was referred to the CVMP.
Produktet administreres topikalt på dyrets ryg og er indiceret til behandling af blandede infektioner med nematoder og ikter hos kvæg. 
The product is administered topically on the back of the animal and is indicated for the treatment of mixed nematode and fluke infections in cattle.
Internationale fællesnavne (INN): moxidectin og triclabendazol 
International non-proprietary names (INN): moxidectin and triclabendazole
Indehaveren af markedsføringstilladelsen afgav skriftlige redegørelser den 20. maj 2013. 
Written explanations were provided by the marketing authorisation holder on 20 May 2013.
På dag 90 var de alvorlige problemer, der var rejst af den berørte medlemsstat Belgien, fortsat uafklarede. 
On Day 90, major issues raised by the CMS, Belgium, remained unsolved.
Henvisningsproceduren blev indledt den 10. april 2013. 
The referral procedure started on 10 April 2013.
Den 3. april 2013 indbragte Frankrig sagen for CVMP i henhold til artikel 13, stk. 2, i Kommissionens forordning (EF) nr. 1234/2008. 
On 3 April 2013, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Under ændringsproceduren konstaterede Belgien en potentiel alvorlig risiko for dyrs sundhed, herunder at virkningen mod de pågældende lusearter ikke var tilstrækkeligt dokumenteret. 
During the variation procedure a potential serious risk to animal health was identified by Belgium and in particular that the efficacy against the lice species had been insufficiently substantiated.