natgillin/translations-raw huggingface dataset:
Rifampicin virker stærkt fremmende på CYP3A4-systemet. 
Rifampicin strongly induces the CYP3A4 system.
Almindelige (mere end 1 ud af 100, men mindre end 1 ud af 10 patienter): - angina (ved pludselig seponering af nifedipin) - uregelmæssigt hjerteslag (palpitationer) - hjertestop - træthed - konstipation - svimmelhed - kvalme - øget hyppighed eller forværring af angina - øget iltmangel i hjertet, inkl. 
Common (more than 1 out of 100, but less than 1 out of 10 patients): - angina (upon sudden withdrawal of nifedipine) - irregular heart beat (palpitations) - heart failure - tiredness - constipation - dizziness - nausea - increased frequency or worsening of angina - increased shortage of oxygen in the heart, including a heart attack - low blood pressure (hypotension) - sudden low blood pressure that occurs when a assuming a standing position (orthostatic hypotension).
- Sjældne: 
- Rare:
anbefaler CPMP, at der udstedes markedsføringstilladelser for Nifedipine Pharmamatch Retard 30/60 mg og de tilknyttede navne (se bilag I). 
The CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summaries of Product Characteristics, labelling and package leaflet are set out in Annex III for Nifedipinr Pharmamatch Retard 30/60 mg and associated names (see Annex I).
Nifedipin udskilles i små mængder i modermælken. 
Nifedipine is excreted into breast milk in small amounts.
Perifert ødem, ansigtsrødne (flushing). 
- Very common: peripheral oedema, flushing (facial reddening).
Hver tablet indeholder: 30 mg nifedipin 
Each tablet contains: 30 mg nifedipine
Hver tablet indeholder: 60 mg nifedipin 
Each tablet contains: 60 mg nifedipine
Høre- og labyrinthforstyrrelser: - Meget sjældne: 
Ear and labyrinth disorders: - Very rare:
Stoffer, der hæmmer CYP3A4 
Substances that inhibit CYP3A4
Muskuloskeletale- og bindevævslidelser: - Sjældne: 
Musculoskeletal and connective tissue disorders: - Rare:
Pharmachemie B.V. 
Pharmamatch B.V. Postbus 82
Hvad Nifedipine Pharmamatch retard indeholder 
What Nifedipine Pharmamatch retard contains
30 mg / 60 mg Depottablet 
30 mg / 60 mg prolonged-release tablets
I tilfælde af samtidig brug af begge lægemidler, bør blodtrykket monitoreres og dosis af nifedipin bør om nødvendigt nedsættes. 
In case of concomitant use of both medicines, blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered.
- blegner på huden, hvor den bliver udsat for sollys (fototoksicitet) - pludselig forværring af nyrefunktion hos patienter med kroniske nyreproblemer - hævelser omkring øjnene (periorbitalt ødem) - støj i ørerne (tinnitus). 
Very rare (Les than 1 out of 10.000 patients): - bedwetting - depression - blistering of the skin when exposed to sunlight (phototoxicity) - sudden worsening of kidney function in patients with chronic kidney problems - swelling around the eyes (periorbital oedema) - noise in the ear (tinnitus).
Baseret på resultaterne af bioækvivalensundersøgelser kan Nifedipine Pharmamatch retard tabletter på 30 mg og 60 mg betragtes som værende bioækvivalente med referenceproduktet Adalat OROS under faste- og mæthedsforhold. 
The pharmacokinetic properties of nifedipine in the Nifedipine Pharmamatch retard tablet are linear in a dose range of 30-180 mg. Based on the results of the bioequivalence studies, Nifedipine Pharmamatch retard tablets 30 mg and 60 mg can be considered to be bioequivalent to the reference product Adalat OROS under fasting and fed conditions.
Der kan forekomme forstoppelse. 
Constipation (obstruction) can occur.
pludselig død), hjertestop eller død som følge af andre kardiovaskulære årsager (sammensat gennembrud). 
The primary end-point was the combination of stroke, MI (including sudden death), heart failure or death from any other cardiovascular cause (composite end-point).
Ved samtidig brug bør blodtrykket monitoreres, og dosis af nifedipin bør om nødvendigt nedsættes. 
In case of concomitant use, blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) RVG 31822 - Nifedipine Pharmamatch retard 30 mg, depottabletter 
RVG 31822 - Nifedipine Pharmamatch retard 30 mg, prolonged-release tablets
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Nifedipine Pharmamatch retard 30 mg depottabletter 
PACKAGE LEAFLET: INFORMATION FOR THE USER Nifedipine Pharmamatch retard 30 mg prolonged-release tablets
Meget almindelige (mere end 1 ud af 10 patienter): - hovedpine - rødme - hævelse, især af ankler og ben - svimmelhed - ørhed - følelsen af tryk i hovedet. 
Very common (more than 1 out of 10 patients): - headache - flushing - swelling, particularly of the ankles and legs
Nifedipine Pharmamatch retard bør altid tages i nøje overensstemmelse med Deres læges instruktioner. 
Always take Nifedipine Pharmamatch retard exactly as your doctor has told you.
- De øvrige indholdsstoffer er: Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b) og titaniumdioxid (E171). 
- The other ingredients are: carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E533b) and titanium dioxide (E171).
Specielt ved depotprodukter (Nifedipine Pharmamatch retard) skal udskillelsen være så komplet som muligt, inkl. 
Especially for prolonged-release products (Nifedipine Pharmamatch retard) elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance.
Hvordan De opbevarer Nifedipine Pharmamatch retard Yderligere oplysninger 
How to store Nifedipine Pharmamatch retard Further information
Nifedipine Pharmamach retard tabletter leveres i en kalenderpakning med 28 tabletter (2 blisterpakninger med hver 14 tabletter). 
Nifedipine Pharmamach retard tablets come in a calendar packing of 28 tablets (2 blisters of 14 tablets each).
Biotilgængeligheden er ca. 40-60%. 
Bioavailability is approximately
Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b), titandioxid (E171) 
Carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E533b), titanium dioxide (E171)
Lidelser i luftveje, thorax og mediastinum: - Meget sjældne: 
Respiratory, thoracic and mediastinal disorders: - Very rare:
Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b) og titaniumdioxid (E171). 
Carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E553b) and titanium dioxide (E171).
- Hvis De har en alvorlig forsnævring i tarmsystemet. 
- if you have a severe narrowing of the gastrointestinal tract.
angina ved pludselig seponering af nifedipin, øget hyppighed eller forværring af angina, aggravation af myokardial iskæmi inkl. 
angina upon abrupt withdrawal of nifedipine, increased frequency or worsening of angina, aggravation of myocardial ischemia including myocardial infarction, palpitations (tachycardia - accelerated pulse rate), congestive heart failure, hypotension, orthostatic hypotension.
Om nødvendigt kan dosen øges i henhold til det individuelle behov, dog op til maks. 
If necessary the dosage can be increased according to individual requirements up to a maximum of 90mg once-daily.
Muskelkramper. 
muscle cramps.
Forstyrrelser i reproduktion og lidelser i mammae: - Ualmindelige: 
Reproductive system and breast disorders: - Uncommon:
embryotoksicitet og teratogenisk effekt ved maternelt toksiske doser. 
Studies in animals have shown reproductive toxicity, consisting of embryotoxicity and teratogenic effects at maternally toxic doses.
BILAG III PRODUKTRESUME 
SUMMARY OF PRODUCT CHARACTERISTICS
- trækninger i fingrene - feber de første par dage efter behandlingens start - forbigående forøgelse af leverenzymer - oesophageal reflux - allergisk leverinfektion - øget blodtryk i portalvenen hos patienter med alkoholinduceret cirrhose - degradering af livmoderens slimhinde (endometriatrofi) - nedsat blodgennemstrømning til fingre og tæer (reduktion af blodgennemstrømningen) hos patienter med Raynaud's syndrom 
Uncommon (more than 1 out of 1.000, but less than 1 out of 100 patients): - heart rhythm disturbances - increased sensitivity, particularly in arms and legs - eye reactions such as eye pain, temporary vision disturbances - finger twitching - fever in the first few days after start of therapy - transient increase in liver enzymes - oesophageal reflux - allergic liver infection - increased blood pressure in the portal vein in patients with alcoholic cirrhosis - degradation of the mucous membrane of the uterus (atrophic endometrium) - reduction in blood flow to the fingers and toes (digital blood flow reduction) in patients with
Nifedipine Pharmamatch 60 mg tabletter findes som depottabletter i en kalenderpakning af 28 tabletter (2 blisterpakninger med 14 tabletter). 
Nifedipine Pharmamatch 60 mg tablets are available as prolonged-release tablets in a calendar packaging of 28 tablets (2 blisters of 14 tablets).
Nifedipine Pharmamatch 30 mg tabletter findes som depottabletter i en kalenderpakning af 28 tabletter (2 blisterpakninger med 14 tabletter). 
Nifedipine Pharmamatch 30 mg tablets are available as prolonged-release tablets in a calendar packaging of 28 tablets (2 blisters of 14 tablets).
Nifedipine Pharmamatch retard 30 mg, depottabletter indeholder 30 mg nifedipin pr. tablet. 
Nifedipine Pharmamatch retard 30 mg, prolonged-release tablets contain 30 mg nifedipine per tablet.
Depottabletter. 
Prolonged-release tablets.
Nifedipine Pharmamatch retard 60 mg, depottabletter indeholder 60 mg nifedipin pr. tablet. 
Nifedipine Pharmamatch retard 60 mg, prolonged-release tablets contain 60 mg nifedipine per tablet.
HVORDAN DE TAGER NIFEDIPINE PHARMAMATCH RETARD 
HOW TO TAKE NIFEDIPINE PHARMAMATCH RETARD
hovedpine, svimmelhed, ørhed, følelsen af tryk i hovedet. 
- giddiness - light headedness - feeling of pressure in the head.
Lidelser i blod og lymfe: - Meget sjældne: 
Blood and lymphatic system disorders: - Very rare:
HVORDAN DE OPBEVARER NIFEDIPINE PHARMAMATCH RETARD 
HOW TO STORE NIFEDIPINE PHARMAMATCH RETARD
HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE NIFEDIPINE PHARMAMATCH 
BEFORE YOU TAKE NIFEDIPINE PHARMAMATCH
Hvordan De tager lægemidlet 
How to take
4.2 Dosering og indgivelsesmåde 
4.2 Posology and method of administration For oral administration.
som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek. 
If you have any further questions on the use of this product, ask your doctor or pharmacist.
LÆGEMIDLETS NAVN Nifedipine Pharmamatch retard 60 mg depottabletter Nifedipin. 
NAME OF THE MEDICINAL PRODUCT Nifedipine Pharmamatch retard 60 mg prolonged-release tablets Nifedipine.
FORTEGNELSE OVER HJÆLPESTOFFER 
colouring aid
Der savnes oplysninger om en farmakologisk effekt hos spædbarnet pga. dette. 
It is not known if a pharmacological effect in the infant can occur because of this; however, it is recommended to cease breast feeding as a precautionary measure.
LÆGEMIDLETS NAVN Nifedipine Pharmamatch retard 30 mg depottabletter Nifedipin. 
NAME OF THE MEDICINAL PRODUCT Nifedipine Pharmamatch retard 30 mg prolonged-release tablets Nifedipine.
Nifedipine Pharmamatch retard 60 mg depottabletter Nifedipin 
Nifedipine Pharmamatch retard 60 mg prolonged-release tablets Nifedipine
Der savnes oplysninger om risiko for det ammende barn. 
It is not known if this can lead to an effect in the infant.
Nifedipine Pharmamatch retard 30 mg depottabletter Nifedipin 
Nifedipine Pharmamatch retard 30 mg prolonged-release tablets Nifedipine
6.5 Emballage 
6.5 Nature and contents of container
Vigtige oplysninger om visse af indholdsstofferne i Nifedipine Pharmamatch retard Nifedipine Pharmamatch retard indeholder lactose. 
Important information about some of the ingredients of Nifedipine Pharmamatch retard
Dosen kan øges i henhold til det individuelle behov, dog op til maks. 
The dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily.
- rødme - hævelse, især af ankler og ben - svimmelhed - ørhed - følelsen af tryk i hovedet. 
General disorders and administration site conditions: - Very common: headache, giddiness, light headedness, feeling of pressure in the head.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) RVG 31823 - Nifedipine Pharmamatch retard 60 mg, depottabletter 
RVG 31823 - Nifedipine Pharmamatch retard 60 mg, prolonged-release tablets DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2004
ETIKETTERING OG INDLÆGSSEDDEL 
QUALITATIVE AND QUANTITATIVE COMPOSITION
myokardial infarkt, palpitationer (tachykardia - accelereret puls), 
Cardiovascular disorders: - Very common: peripheral oedema, flushing (facial reddening).
Den anbefalede dosis er 350 mg én gang hver tredje uge. 
The recommended dose is 350 mg once every 3 weeks.
Studiet omfattede imidlertid et lille antal patienter, og der er behov for yderligere data. 
However, the study involved a small number of patients and additional data are required.
Yderligere information om Libtayo findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/libtayo. 
Further information on Libtayo can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/libtayo.
Det anvendes hos patienter, der ikke kan gennemgå en operation eller en behandling med stråling for at helbrede deres sygdom. 
It is used in patients who cannot have surgery or treatment with radiation to cure their disease.
Libtayo har fået en "betinget godkendelse". 
Libtayo has been given ‘conditional authorisation'.
Hvad angår lægemidlets sikkerhed, er bivirkningerne håndterbare og svarer til dem, der ses ved andre kræftbehandlinger af denne type. 
As for the medicine's safety, its side effects are manageable and similar to those seen in other cancer treatments of this type.
I et hovedstudie, hvori der indgik i alt 193 patienter, blev kræften mindre hos ca. 39 % af de patienter med metastatisk sygdom, som fik 350 mg Libtayo hver 3. uge i ca. et år. 
In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received 350 mg Libtayo every 3 weeks for around one year.
Virksomheden vil også undersøge, om lægemidlet virker anderledes, afhængigt af niveauet af PD-L1, som produceres af kræftcellerne. 
The company will also investigate whether the medicine works differently depending on the levels of PD-L1 produced by the cancer cells.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Libtayo opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency therefore decided that Libtayo's benefits are greater than its risks and it can be authorised for use in the EU.
Som for alle lægemidler er data vedrørende brug af Libtayo løbende overvåget. 
As for all medicines, data on the use of Libtayo are continuously monitored.
Behandlingen kan fortsætte, så længe sygdommen er stabil, og patienten kan tolerere bivirkningerne. 
Treatment can continue for as long as the disease remains stable and the patient does not experience unacceptable side effects.
Libtayo indeholder det aktive stof cemiplimab. 
Libtayo contains the active substance cemiplimab.
Andre oplysninger om Libtayo 
Other information about Libtayo
Behandling med Libtayo skal indledes og overvåges af en læge med erfaring i behandling af kræft. 
Treatment with Libtayo must be started and supervised by a doctor experienced in treating cancer.
For mere information om brug af Libtayo, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Libtayo, see the package leaflet or contact your doctor or pharmacist.
Bivirkninger rapporteret for Libtayo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Libtayo are carefully evaluated and any necessary action taken to protect patients.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Libtayo? 
What measures are being taken to ensure the safe and effective use of Libtayo?
Libtayo er forbundet med bivirkninger, der er knyttet til immunsystemets aktivitet, og de kan være alvorlige, selv om de fleste bivirkninger ophører efter en passende behandling, eller ved at ophøre med brug af Libtayo. 
Libtayo is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping Libtayo.
Libtayo gives som en infusion (drop) i en vene i løbet af 30 minutter. 
Libtayo is given as an infusion (drip) into a vein lasting 30 minutes.
Svære reaktioner, herunder Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (livstruende reaktioner med influenzalignende symptomer og smertefuld udsæt, der påvirker huden, munden, øjnene og kønsdelene), er indberettet med Libtayo. 
Severe reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with Libtayo.
Hos patienter med lokalt fremskreden sygdom, som fik Libtayo hver 2. uge (i en dosis på 3 mg/kg legemsvægt) i ca. 2 år, var kræften blevet mindre hos 44 % af dem. 
Among patients with locally advanced disease who received Libtayo every 2 weeks (at a dose of 3 mg/kg bodyweight) for around 2 years, 44% of patients showed shrinkage of their cancer.
Hvad er Libtayo, og hvad anvendes det til? 
What is Libtayo and what is it used for?
De mest almindelige immunitetsrelaterede virkninger (som kan forekomme hos op til 1 ud af 10 personer) var hypothyreoidisme (en underaktiv skjoldbruskkirtel med træthed, vægtforøgelse og hud- og hårforandring), pneumonitis (betændelse i lungerne, som forårsager åndenød og hoste), hudreaktioner, hyperthyreoidisme (en overaktiv skjoldbruskkirtel, der kan forårsage hyperaktivitet, svedafsondring, vægttab og tørst) og betændelse i leveren. 
The most common immune-related effects (which may affect up to 1 in 10 people) were hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).
Virksomheden, der markedsfører Libtayo, skal udlevere en vejledning og et patientkort til patienterne med oplysninger om tegn og symptomer på immunrelaterede bivirkninger ved lægemidlet samt anvisninger om at kontakte deres læge, hvis de oplever symptomer. 
The company that markets Libtayo will provide a guide and an alert card for patients with information on the signs and symptoms of immune-related side effects of the medicine, as well as instructions on contacting their doctor if they experience symptoms.
En oversigt over Libtayo, og hvorfor det er godkendt i EU 
An overview of Libtayo and why it is authorised in the EU
Hvorfor blev Libtayo godkendt i EU? 
Why is Libtayo authorised in the EU?
Kræftceller kan producere proteiner (PD-L1 og PD-L2), der binder sig til denne receptor og afbryder T-cellernes aktivitet, så de ikke kan angribe kræften. 
Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Libtayo er et kræftlægemiddel, der anvendes alene til behandling af voksne med hudkræft, kaldet kutant planocellulært karcinom, når kræften er lokalt fremskreden (har spredt sig i nærheden) eller metastatisk (har bredt sig til andre dele af kroppen). 
Libtayo is a cancer medicine used on its own to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body).
Eftersom Libtayo har fået en betinget godkendelse, vil virksomheden, der markedsfører Libtayo, fremlægge data fra et igangværende studie af lægemidlets virkning og sikkerhed ved behandling af kutant planocellulært karcinom. 
Since Libtayo has been given conditional authorisation, the company that markets Libtayo will provide data from an ongoing study on the effectiveness and safety of the medicine for cutaneous squamous cell carcinoma.
Hvilke oplysninger afventes der stadig for Libtayo? 
What information is still awaited for Libtayo?
Det aktive stof i Libtayo, cemiplimab, er et monoklonalt antistof, dvs. en type protein, der er opbygget, så det genkender og binder sig til en receptor kaldet PD-1, som findes på bestemte celler i immunsystemet kaldet T-celler. 
The active substance in Libtayo, cemiplimab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Hvilke risici er der forbundet med Libtayo? 
What are the risks associated with Libtayo?
Det betyder, at virksomheden er blevet pålagt at fremskaffe mere viden om lægemidlet. 
This means that there is more evidence to come about the medicine, which the company is required to provide.
Den fuldstændige liste over bivirkninger og begrænsninger ved Libtayo fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Libtayo, see the package leaflet.
Libtayo er effektivt til behandling af kutant planocellulært karcinom, en kræftform med få behandlingsmuligheder, når den har spredt sig. 
Libtayo is effective at treating cutaneous squamous cell carcinoma, a cancer with few treatment options once it has spread.
Libtayo er effektivt til behandling af kutant planocellulært karcinom hos mange patienter. 
Libtayo is effective at treating cutaneous squamous cell carcinoma in many patients.
Hvordan virker Libtayo? 
How does Libtayo work?
Ved at binde sig til receptoren forhindrer cemiplimab PD-L1 og PD-L2 i at slukke for T-cellerne. 
By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Libtayo. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Libtayo have also been included in the summary of product characteristics and the package leaflet.
Hvordan anvendes Libtayo? 
How is Libtayo used?
Hvilke fordele viser studierne, at der er ved Libtayo? 
What benefits of Libtayo have been shown in studies?
SERETIDE DISKUS og tilknyttede navne (se bilag I) 
SERETIDE DISKUS and associated names (See Annex I)
I proceduren for gensidig anerkendelse er Sverige referencemedlemsstaten, og Østrig, Belgien, Danmark, Finland, Frankrig, Grækenland, Tyskland, Italien, Irland, Luxembourg, Nederlandene, Portugal, Spanien og Det Forenede Kongerige er de berørte medlemsstater. 
In the MRP Sweden is the Reference Member State (RMS) and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Luxembourg, The Netherlands, Portugal, Spain and the United Kingdom are Concerned Member States (CMS).
Seretide Diskus og tilknyttede navne er godkendt i en række EU-medlemsstater gennem proceduren for gensidig anerkendelse. 
In several EU Member States Seretide Diskus and associated names are approved through the Mutual Recognition Procedure (MRP).
4. juli 2006 EMEA/306065/2006 
4 July 2006 EMEA/306065/2006