FrancophonIA/ELRC3.0 huggingface dataset:
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Danish: Synkope (besvimelse) kan forekomme inden eller efter alle vaccinationer som en psykogen reaktion på injektionen og kan være ledsaget af adskillige neurologiske symptomer, såsom forbigående synsforstyrrelser, paræstesier og toniske-kloniske kramper under opvågningen.
English: assays) and reduced seroprotection rates in adults and elderly (≥ 61 years old) subjects with underlying medical or immunosuppressive conditions, suggest that AFLUNOV may not elicit the same level of protection against A/H5N1 strain as compared to healthy adults (see section 4.4).
Danish: I begge studierne V87_25 og V87_26 tyder de lavere niveauer af antistoffer (målt ved hjælp af HI-, SRH- og MN-analyser) og reducerede seroprotektionsrater hos voksne og ældre (≥ 61 år) forsøgspersoner med underliggende medicinske eller immunsuppressive tilstande på, at AFLUNOV muligvis ikke fremkalder det samme niveau af beskyttelse mod A/H5N1-stammen sammenlignet med raske voskne (se pkt.
English: Rare
Danish: Raske
English: Geometric Mean Area (95%CI)* Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Danish: Geometrisk middelareal (95 % CI)* Seroprotektionsrate (95 % CI)* Serokonverteringsrate (95 % CI)* Serokonverteringsfaktor (95 % CI)**
English: • Hardening of the skin at the injection site
Danish: • Hårdhed på injektionsstedet
English: Seroprotection rate (95%CI) ° Seroconversion rate (95%CI) ° Seroconversion factor (95%CI) °°
Danish: Serokonverteringsrate (95 % CI)° serokonverteringsfaktor (95 % CI)°°
English: * measured by SRH assay seroprotection: SRH area ≥25 mm2, seroconversion: SRH area ≥25 mm2 for subjects with a baseline SRH area ≤4 mm2 or a minimum 50% increase in SRH area for subjects with >4 mm2.
Danish: Ældre (61-91 år)a a faktisk aldersinterval for inkluderet population * målt ved SRH-analyse - seroprotektion: SRH-areal ≥ 25 mm2, serokonvertering: SRH-areal ≥ 25 mm2 for forsøgspersoner med et baseline-SRH-areal ≤ 4 mm2 eller en mindst 50 % stigning i SRH-areal for forsøgspersoner med > 4 mm2.
English: • Shivering
Danish: • Svedtendens
English: Any
Danish: Alle
English: • Brusing of the skin at the injection site
Danish: • Blå mærker ved injektionsstedet
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)***
Danish: Seroprotektionsrate (95 % CI) * Serokonverteringsrate (95 % CI)** Serokonverteringsfaktor (95 % CI)***
English: Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=84a
Danish: Studie V87P1 A/Vietnam/1194/2004 21 dage efter 2. dosis N=84a
English: • Convulsions
Danish: • Træthed
English: • Fits
Danish: • Prikken
English: Anti-HA antibody Study V87P12 21 days after 2nd dose N=60
Danish: Studie V87P12 21 dage efter 2. dosis N=60
English: AFLUNOV
Danish: Kramper
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=210b
Danish: Studie V87P13 A/Vietnam/1194/2004 21 dage efter 2. dosis N=210b
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=128
Danish: Studie V87P13 A/Vietnam/1194/2004 21 dage efter 2. dosis N=128
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=69
Danish: Studie V87P13 A/Vietnam/1194/2004 21 dage efter 2. dosis N=69
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=66
Danish: Studie V87P13 A/Vietnam/1194/2004 21 dage efter 2. dosis N=66
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=143
Danish: Studie V87P13 A/Vietnam/1194/2004 21 dage efter 2. dosis N=143
English: To be administered intramuscularly into the deltoid muscle.
Danish: Administreres intramuskulært i deltamusklen.
English: If they persist, CONSULT YOUR DOCTOR.
Danish: SØG LÆGE, hvis bivirkningerne varer ved.
English: °° GMRs of HI
Danish: *** GMR'er af SRH ° målt ved HI-analyse ≥ 40 °° GMR'er af HI
English: Seroconversion rate (95%CI)°
Danish: Serumbeskyttelsesrate (95 % CI)*
English: • Tingling
Danish: • Kramper
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Danish: Det betyder, at der findes litteraturoplysninger, der danner videnskabelig dokumentation for virkning og sikkerhed ved denne anvendelse, og som dækker en periode på mindst 10 år i EU.
English: Castor oil medicines should only be used in adults, and should not be taken for longer than one week without medical supervision.
Danish: Lægemidler med ricinusolie bør kun anvendes til voksne og bør ikke anvendes i mere end en uge uden lægeligt tilsyn.
English: This means that the oil is extracted from the seeds by crushing and pressing them without heating.
Danish: Dette betyder, at olien udvindes af frøene ved knusning og presning uden anvendelse af varme.
English: They should not be used during pregnancy and breastfeeding.
Danish: Lægemidler med ricinusolie bør ikke anvendes under graviditet og amning.
English: Any applications for the licensing of medicines containing castor oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder ricinusolie, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Castor oil is the common name for the oil obtained from the seeds of the plant Ricinus communis L. The HMPC conclusions only cover castor oil preparations which are obtained by ‘cold expression' of the seeds.
Danish: Ricinusolie er fællesnavnet for den olie, der fremstilles af frøene af planten Ricinus communis L. HMPC's konklusioner omfatter kun tilberedninger af ricinusolie, som fremstilles ved koldpresning af frøene.
English: Castor oil preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af ricinusolie findes desuden kombineret med andre droger i visse plantelægemidler.
English: This increases the water content of stools, making them softer and easier to pass.
Danish: Derved øges vandindholdet i afføringen, der bliver blødere og lettere at komme af med.
English: In its assessment, the HMPC considered two clinical studies which showed a laxative effect for castor oil medicines in constipated patients.
Danish: HMPC har i sin vurdering lagt vægt på to kliniske undersøgelser, der har påvist en afførende virkning ved lægemidler med ricinusolie hos patienter med forstoppelse.
English: Information on the use and licensing of castor oil medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder ricinusolie, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: When ingested, castor oil is broken down into ricinoleic acid which works by reducing absorption of fluid and salts in the small intestine (the upper part of the bowel).
Danish: Ved indtagelse nedbrydes ricinusolie til ricinolinsyre, der virker ved at mindske optaget af væske og salte i tyndtarmen (den øvre del af tarmsystemet).
English: What is castor oil?
Danish: Hvad er ricinusolie?
English: In one of the studies the effects of castor oil capsules were similar to those of senna capsules (another herbal preparation commonly used to treat constipation).
Danish: I en af undersøgelserne havde kapsler med ricinusolie samme virkning som kapsler med sennes (en anden drogetilberedning, der ofte anvendes til behandling af forstoppelse).
English: Further information on the HMPC assessment of castor oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder ricinusolie, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of castor oil.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af ricinusolie.
English: Herbal medicines containing these castor oil preparations are usually available in solid or liquid forms to be taken by mouth.
Danish: Plantelægemidler med ricinusolie i disse tilberedninger fås normalt i fast eller flydende form til anvendelse gennem munden.
English: Detailed instructions on how to take castor oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med ricinusolie bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Further information on the risks associated with castor oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder ricinusolie, herunder passende forholdsregler, der skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that these castor oil preparations can be used for short term as laxatives for occasional constipation.
Danish: HMPC har konkluderet, at ricinusolie i disse tilberedninger kan anvendes i kortere perioder som afføringsmiddel ved lejlighedsvis forstoppelse.
English: The HMPC conclusions on the use of these castor oil medicines as laxatives are based on their ‘wellestablished use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med ricinulolie som afføringsmiddel er baseret på den "almindeligt anerkendte anvendelse".
English: These include nausea, vomiting abdominal (belly) pain and severe diarrhoea.
Danish: Disse bivirkninger omfatter kvalme, opkastning, mavesmerter og svær diarré.
English: Castor oil medicines should not be taken in case of obstruction or narrowing of the gut, atony (loss of normal movement in the gut muscle), appendicitis (inflammation of the appendix, a small organ connected to the bowel), inflammatory diseases of the colon (the lower part of the bowel), unexplained abdominal pain and severe dehydration.
Danish: Lægemidler med ricinusolie bør ikke tages ved blokering eller forsnævring af tarmene, nedsat bevægelighed af tarmene, blindtarmsbetændelse, betændelsestilstande i tyktarmen (den nedre del af tarmsystemet), uforklarlige mavesmerter og svær væskemangel.
English: How are castor oil medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder ricinusolie, i EU?
English: Castor oil
Danish: Ricinusolie
English: This summary is not intended to provide practical advice on how to use medicines containing castor oil.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder ricinusolie, skal anvendes.
English: How does castor oil work as a medicine?
Danish: Hvordan virker risinunolie som lægemiddel?
English: Other information about castor oil medicines
Danish: Andre oplysninger om lægemidler, der indeholder ricinusolie
English: What evidence supports the use of castor oil medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af ricinusolie?
English: What are the risks associated with castor oil medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder ricinusolie?
English: For more information about treatment with castor oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder ricinusolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: In addition, castor oil stimulates movement in the intestines which will help to pass the stools.
Danish: Derudover stimulerer ricinusolie tarmbevægelserne, hvilket også virker fremmende på afføringen.
English: For practical information about using castor oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med ricinusolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Member States when evaluating applications for the licensing of herbal medicines containing castor oil.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder ricinusolie.
English: Side effects have been reported with castor oil.
Danish: Der er indberettet bivirkninger ved brug af lægemidler, der indeholder ricinusolie.
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/08/498/002 Thymanax
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: Conditional marketing authorisation
Danish: Betinget markedsføringstilladelse
English: <Similarity>
Danish: <Similaritet>
English: <Derogation>
Danish: <Undtagelse>
English: [For the conditional marketing authorisation status and, in case of similarity and an accepted derogation, please select the statement(s) as provided below.]
Danish: [For the conditional marketing authorisation status and, where appropriate, for similarity and derogation, please select the statement(s) as provided below.]
English: CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION AND <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: KONKLUSIONER VEDRØRENDE UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER BETINGEDE OMSTÆNDIGHEDER OG <SIMILARITET> <OG> <UNDTAGELSE> <OG> <ANMODNING OM <MARKEDSFØRINGSBESKYTTELSE> <DATABESKYTTELSE> I ET ÅR> FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: <the holder of the marketing authorisation for <authorised orphan medicinal product> is unable to supply sufficient quantities of the medicinal product> <and>
Danish: <indehaveren af markedsføringstilladelsen for {det godkendte lægemiddel til sjældne sygdomme} er ikke i stand til at levere tilstrækkelige mængder af lægemidlet> <og>
English: <the holder of the marketing authorisation for <authorised orphan medicinal product> has given his consent to the applicant.>
Danish: <indehaveren af markedsføringstilladelsen for {det godkendte lægemiddel til sjældne sygdomme} har givet sit samtykke til ansøgeren.>>
English: <The CHMP is of the opinion that pursuant to Article 8 of Regulation (EC) No. 141/2000 and <Article 3 of Commission Regulation (EC) No 847/2000> [only for the superiority derogation] the following derogation
 laid down in Article 8.3 of the same Regulation apply(ies) as further explained in European Public Assessment Report :
Danish: <CHMP er den opfattelse, at i henhold til artikel 8 i forordning (EC) nr. 141/2000 og <artikel 3 i Kommissionens forordning (EC) nr. 847/2000> [only for the superiority derogation] gælder følgende undtagelse(r), som fastlagt i samme forordnings artikel 8, stk. 3, og beskrevet nærmere i den europæiske offentlige vurderingsrapport:
English: <one-year <marketing protection><data exclusivity>>
Danish: <<Markedsføringsbeskyttelse><Databeskyttelse> i et år>
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and>
Danish: <ansøgeren kan i sin ansøgning påvise, at lægemidlet, selv om det er similært med {det godkendte lægemiddel til sjældne sygdomme, er sikrere, mere effektivt eller på anden vis klinisk overlegent (som defineret i artikel 3 i Kommissionens forordning (EC) nr. 847/2000) ved den samme terapeutiske indikation> <og>
English: [For Art 14(11)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report.
Danish: [For Art 14(11)] <CHMP gennemgik de oplysninger, som indehaveren af markedsføringstilladelsen havde indsendt, jf. artikel 14, stk. 11, i forordning (EC) nr. 726/2004, og er af den opfattelse, at den nye terapeutiske indikation giver en væsentlig klinisk fordel sammenlignet med eksisterende behandlinger.
English: [Art 10(5)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 10(5) of Directive 2001/83/EC, and considers that <the <pre-clinical tests> <and> <clinical studies> carried out in relation to the new indication were significant as further explained in the European Public Assessment Report.
Danish: [Art 10(5)] <CHMP gennemgik de oplysninger, som indehaveren af markedsføringstilladelsen havde indsendt, jf. artikel 10, stk. 5, i direktiv 2001/83/EC, og er af den opfattelse, at de <prækliniske undersøgelser> <og> <kliniske studier>, der er udført i forbindelse med den nye indikation, er af væsentlig betydning.
English: <The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal products within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report.
Danish: <CHMP er af den opfattelse, at «lægemidlets navn» er similært med allerede godkendte lægemidler til sjældne sygdomme i henhold til artikel 3 i Kommissionens forordning (EC) nr. 847/2000.
English: Belgium APOTEX NV Av. du Bourg.
Danish: APOTEX NV Av. du Bourg.
English: United Kingdom Waymade Plc Regency House
Danish: Storbritannien Waymade Plc Regency House
English: United Kingdom Generics (UK) Limited Station Close
Danish: Storbritannien Generics (UK) Limited Station Close
English: Belgium LABORATORIA QUALIPHAR N.V/S.A
Danish: LABORATORIA QUALIPHAR N.V/S.A
English: PHARMACEUTICAL INDUSTRY PROEL EPAM.
Danish: Grækenland PHARMACEUTICAL INDUSTRY PROEL EPAM.
English: United Kingdom Bristol Laboratories Limited Unit 3, Canal side
Danish: Storbritannien Bristol Laboratories Limited Unit 3, Canal side
English: United Kingdom RI Pharma Limited First floor,6 St John's Court Upper Fforest Way
Danish: Storbritannien RI Pharma Limited First floor,6 St John's Court Upper Fforest Way
English: United Kingdom Daichi-Sankyo UK Limited Chiltern Place
Danish: Storbritannien Daichi-Sankyo UK Limited Chiltern Place
English: Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna
Danish: Østrig ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna
English: Hungary ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a
Danish: Ungarn ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a
English: United Kingdom Galen Limited Seagoe Industrial Estate Craigavon
Danish: Storbritannien Galen Limited Seagoe Industrial Estate Craigavon
English: The Netherlands Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester
Danish: Nederlandene Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester
English: United Kingdom Therabel pharma UK Limited Compass House, vision Park Chivers, Histon
Danish: Storbritannien Therabel pharma UK Limited Compass House, vision Park Chivers, Histon
English: United Kingdom Actavis UK Limited Whiddon Valley
Danish: Storbritannien Actavis UK Limited Whiddon Valley
English: United Kingdom Dexcel Pharma Limited 7 Sopwith Way
Danish: Storbritannien Dexcel Pharma Limited 7 Sopwith Way
English: Metamorfosi 14452 Greece
Danish: Metamorfosi 14452
English: Oral drops, suspension
Danish: Orale dråber, suspension
English: 12th Km National Highway No 1, Metamorfosi Attikis 144 51 Greece
Danish: 12th Km National Highway No 1, Metamorfosi Attikis 144 51
English: MEDICUS S.A Valaoritou 10
Danish: Grækenland MEDICUS S.A Valaoritou 10
English: United Kingdom Teva UK Limited Brampton Road
Danish: Storbritannien Teva UK Limited Brampton Road
English: United Kingdom Chelonia Healthcare Limited Boumpoulinas 11
Danish: Storbritannien Chelonia Healthcare Limited Boumpoulinas 11
English: PHARMASWISS HELLAS A.E. Pentelis Avenue 53
Danish: Grækenland PHARMASWISS HELLAS A.E. Pentelis Avenue 53
English: Oral drops, solution
Danish: Orale dråber, solution
English: United Kingdom Aptil Pharma limited 9th Floor
Danish: Storbritannien Aptil Pharma limited 9th Floor
English: United Kingdom Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom
Danish: Storbritannien Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom
English: United Kingdom Crescent Pharma Limited Unit 3&4
Danish: Storbritannien Crescent Pharma Limited Unit 3&4
English: RAFARM AEBE Korinthou 12
Danish: Grækenland RAFARM AEBE Korinthou 12
English: United Kingdom Pfizer Limited Ramsgate Road
Danish: Storbritannien Pfizer Limited Ramsgate Road
English: United Kingdom Focus Pharmaceuticals Limited Unit 5, Faraday court
Danish: Storbritannien Focus Pharmaceuticals Limited Unit 5, Faraday court
English: NOVARTIS (HELLAS) A.E.B.E.
Danish: Grækenland NOVARTIS (HELLAS) A.E.B.E.
English: N. Psychiko, 15451 Greece
Danish: N. Psychiko, 15451
English: Granules for oral suspension
Danish: Granulat til oral suspension
English: United Kingdom Chatfield Pharmaceuticals Limited
Danish: Storbritannien Chatfield Pharmaceuticals Limited
English: 811 05 Bratislava
Danish: 811 05 Bratislava Slovak Republic
English: United Kingdom Mercury Pharma Group Limited No. 1 Croydon
Danish: Storbritannien Mercury Pharma Group Limited No. 1 Croydon
English: PHARMATHEN International S.A.Greece
Danish: Grækenland PHARMATHEN International S.A.Greece
English: United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom
Danish: Storbritannien Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom
English: Intramuscular injection or intravenous infusion.
Danish: Intramuskulær injection eller intravenous infusion.
English: United Kingdom Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS
Danish: Storbritannien Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS
English: Diclofenac potassium CATAFLAM ORAL DROPS 1.5%
Danish: Diclofenackalium CATAFLAM ORAL DROPS 1.5%
English: Slovak Republic MEDOPHARM s.r.o., Lehárova 143 00, Praha 4
Danish: MEDOPHARM s.r.o., Lehárova 143 00, Praha 4
English: The Netherlands Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent
Danish: Nederlandene Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent
English: 2880 Bornem
Danish: 2880 Bornem Belgium
English: Parenteral use;
Danish: Parenteral anvendelse;
English: 53003 Pardubice
Danish: 53003 Pardubice Czech Republic
English: United Kingdom Sandoz Limited Frimley Business Park Frimley
Danish: Storbritannien Sandoz Limited Frimley Business Park Frimley
English: United Kingdom Morningside Healthcare Limited 115 Narborough Road
Danish: Storbritannien Morningside Healthcare Limited 115 Narborough Road
English: Belgium Continental Pharma Rijksweg, 12
Danish: Continental Pharma Rijksweg, 12
English: Diclofenac sodium POLYFLAM EX RUFIMAX EX
Danish: Diclofenacnatrium POLYFLAM EX RUFIMAX EX