natgillin/translations-raw huggingface dataset:
Også i denne undergruppe blev der set forbedringer i justeret gennemsnitligt trough-FEV1 (44 ml, 95 % konfidensinterval 15-73 ml; p=0,003) ved uge 52, når fluticasonfuroat/vilanterol 92/22 mikrogram blev sammenlignet med vilanterol 22 mikrogram. 
Improvements were also seen in this subgroup at week 52 when comparing the fluticasone furoate/vilanterol 92/22 micrograms vs. vilanterol 22 micrograms in adjusted mean trough FEV1 (44 mL 95% CI: 15, 73mL, (p=0.003)).
• Efter brug af inhalatoren skylles munden med vand uden at synke det. 
• Rinse your mouth with water after you have used the inhaler, do not swallow.
På dag 169 blev der set en stigning i den justerede gennemsnitlige trough-FEV1 på 129 ml (95 % konfidensinterval 91;167 ml; p < 0,001) med fluticasonfuroat/vilanterol 92/22 mikrogram og på 83 ml (95 % konfidensinterval 46;121 ml; p < 0,001) med vilanterol sammenlignet med placebo. 
At Day 169 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean trough FEV1 by 129 mL (95% CI: 91, 167 mL, p<0.001) and 83 mL (95% CI: 46, 121mL, p<0.001) respectively compared to placebo.
På grund af de lave plasmakoncentrationer, der opnås efter inhalation, anses det for usandsynligt, at kliniske doser af fluticasonfuroat/vilanterol vil medføre klinisk signifikante lægemiddelinteraktioner. 
Clinically significant drug interactions mediated by fluticasone furoate/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
LÆGEMIDLETS NAVN Relvar Ellipta 92 mikrogram/22 mikrogram inhalationspulver, afdelt. 
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader mundstykket) på 184 mikrogram fluticasonfuroat (FF) og 22 mikrogram vilanterol (VI) (som trifenatat). 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
LÆGEMIDLETS NAVN Relvar Ellipta 184 mikrogram/22 mikrogram inhalationspulver, afdelt. 
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Hvis du har glemt at tage Relvar Ellipta 
While you're using Relvar Ellipta
Multipakning med 3 inhalatorer med hver 30 doser. 
Multipack of 3 x 30 dose Inhalers.
1 inhalator med 14 doser 
1 inhaler of 14 doses 1 inhaler of 30 doses
Ellipta-inhalatoren er en lysegrå inhalator med en gul beskyttelseshætte over mundstykket og en dosistæller. 
What Relvar Ellipta looks like and contents of the pack The Ellipta device itself is a light grey inhaler with a yellow mouthpiece cover and a dose counter.
På dag 168 blev der set en stigning i den justerede gennemsnitlig vægtet FEV1 over de første 4 timer på 193 ml (95 % konfidensinterval 156; 230 ml; p < 0,001) med fluticasonfuroat/vilanterol 92/22 mikrogram og 145 ml (95 % konfidensinterval 108; 181 ml; p < 0,001) med vilanterol sammenlignet med placebo. 
At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Relvar Ellipta 92 mikrogram/22 mikrogram inhalationspulver fluticasonfuroat/vilanterol 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 92 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Relvar Ellipta 184 mikrogram/22 mikrogram inhalationspulver fluticasonfuroat/vilanterol 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 184 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Glaxo Operations UK Ltd (handler som Glaxo Wellcome Operations), Priory Street, 
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Priory Street,
HZC102970 og HZC102871 var randomiserede, dobbeltblindede, parallelgruppe-studier af 52 ugers varighed, der sammenlignede effekten af fluticasonfuroat/vilanterol 184/22 mikrogram, fluticasonfuroat/vilanterol 92/22 mikrogram, fluticasonfuroat/vilanterol 46/22 mikrogram med vilanterol 22 mikrogram, alle blev administreret en gang daglig. 
Studies HZC102970 and HZC102871 were 52 week randomised, double-blind, parallel-group, studies comparing the effect of fluticasone furoate/vilanterol 184/22 micrograms, fluticasone furoate/vilanterol 92/22 micrograms, fluticasone furoate/vilanterol 46/22 micrograms with vilanterol 22 micrograms, all administered once daily, on the annual rate of moderate/severe exacerbations in subjects with COPD with a smoking history of at least 10 pack years and a post-salbutamol FEV1/FVC ratio less than or equal to 0.70 and post-salbutamol FEV1 less than or equal to 70% predicted and documented history of ≥ 1 COPD exacerbation that required antibiotics and/or oral corticosteroids or hospitalisation in the 12 months prior to visit 1.
Den er pakket i en bakke af laminatfolie, der indeholder en silica-gel tørrepose. 
The inhaler consists of a light grey body, a yellow mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Ved begge behandlinger blev der set en forbedret lungefunktion over 24 timer målt ved 24 timers justeret gennemsnitlig stigning i vægtet gennemsnitligt FEV1 på 130 ml (fluticasonfuroat/vilanterol) og 108 ml (salmeterol/FP) i forhold til baseline. 
Adjusted mean treatment increases from baseline in weighted mean 0-24 hours FEV1 of 130 mL (fluticasone furoate/vilanterol) and 108 mL (salmeterol/FP) demonstrated an overall improvement in lung function over 24 hours for both treatments.
Den justerede gennemsnitlige ændring i trough-FEV1 på dag 85 i forhold til baseline var 111 ml i fluticasonfuroat/vilanterol-gruppen og 88 ml i salmeterol/FP-gruppen. 
The adjusted mean change from baseline in trough FEV1 on Day 85 was 111 mL in the fluticasone furoate/vilanterol group and 88 mL in the salmeterol/FP group; the 23 mL (95% CI: -20, 66) difference between the treatment groups was not clinically meaningful or statistically significant (p=0.294).
• ledsmerter 
• tremor
Hvis du har taget for meget Relvar Ellipta 
If patients are inadequately controlled on Relvar Ellipta
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver afgivet dosis indeholder 184 mikrogram fluticasonfuroat og 22 mikrogram vilanterol (som trifenatat). 
Each delivered dose contains 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Metabolisme og ernæring Hyperglykæmi 
Metabolism and nutrition disorders
Skriv dato for ”Kasseres senest” i det felt, der er angivet på inhalatorens etiket. 
When the tray is opened, write the “Discard by” date on the inhaler label in the space provided.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver afgivet dosis indeholder 92 mikrogram fluticasonfuroat og 22 mikrogram vilanterol (som trifenatat). 
Each delivered dose contains 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
• udslæt (nældefeber) eller rødme 
• skin rash (hives) or redness
Relvar Ellipta 92 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/vilanterol 
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Brug af anden medicin sammen med Relvar Ellipta Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Relvar Ellipta 184 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/vilanterol 
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
• uregelmæssig hjerterytme (puls) 
• irregular heartbeat
Sympatomimetika 
Desiccant
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader mundstykket) på 92 mikrogram fluticasonfuroat (FF) og 22 mikrogram vilanterol (VI) (som trifenatat). 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Dosistælleren har nu talt 1 ned, og medicinen er klar til at blive inhaleret. 
The medicine is now ready to be inhaled.
Kontakt lægen eller apoteket, hvis du ved et uheld har taget mere Relvar Ellipta, end lægen har foreskrevet. 
If you accidentally take more Relvar Ellipta than your doctor has instructed, talk to your doctor or pharmacist.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/886/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/001
• rygsmerter 
• anxiety
Efter brug af inhalatoren skylles munden med vand uden at synke det. 
Rinse your mouth with water after you have used the inhaler, do not swallow.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/886/004 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/004
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/886/006 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/006
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/886/003 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/003
I HZA106827/HZA106829 var der 2 sammensatte primære endepunkter for effekt: 
In HZA106827/HZA106829 the co-primary efficacy endpoints were change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the treatment period in all subjects and weighted mean serial FEV1 over 0-24 hours post-dose calculated in a subset of subjects at the end of the treatment period.
Studienr. 
Study No.
BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to medical prescription.
• pandehulebetændelse 
• joint pain
Blisterpakning (alu/Aclar) 
Blister (alu/Aclar)
84 kapsler 
84 capsules
100 mg Kapsel, hård 
Capsule, hard
Styrke Lægemiddelform Administration Emballage 
Pharmaceutical Form
Navn 
Strength
Europa-Kommissionen traf en afgørelse den 12. marts 2009. 
The European Commission issued a decision on 12 March 2009.
EMEA/CHMP/194611/2009 EMEA/H/A-29/990 
Ref. EMEA/CHMP/194784/2009 EMEA/H/A-29/990
Revurderingen fandt sted i henhold til en ”artikel 29-indbringelse1. 
The review was carried out under an ‘Article 29' referral1.
Prof. Michal Pirożynski (Polen) 
Prof Michal Pirożynski (Poland)
Dr. Gonzalo Calvo Rojas (Spanien) 
Dr Gonzalo Calvo Rojas (Spain)
Det bevirker, at luftvejene udvider sig, så luften kan passere mere frit. 
This makes the airways widen, allowing the air to flow more freely.
London, den 17. marts 2009 Ref. dok. 
London, 17 March 2009 Doc.
19. marts 2008 
19 March 2008
Hvorfor blev Sabumalin vurderet igen? 
Why was Sabumalin reviewed?
Hvad var CHMP's konklusion? 
What are the conclusions of the CHMP?
Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Sverige) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som gælder i dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Belgien, Danmark, Estland, Finland, Tyskland, Grækenland, Ungarn, Italien, Letland, Litauen, Nederlandene, Polen, Portugal, Slovenien, Spanien og Det Forenede Kongerige samt Norge). 
This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom).
Hvad er Sabumalin? 
What is Sabumalin?
Det betyder, at Sabumalin ligner et referencelægemiddel, som allerede er godkendt i EU, kaldet Sultanol Inhaler. 
This means that Sabumalin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sultanol inhaler.
På grundlag af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at den gavnlige virkning af Sabumalin er større end risiciene, og at markedsføringstilladelsen for Sabumalin derfor bør fornyes i alle de berørte medlemsstater. 
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sabumalin outweigh its risks, and that therefore the marketing authorisation for Sabumalin should be granted in all concerned member states.
Det Europæiske Lægemiddelagentur (EMEA) har afsluttet en procedure for indbragte sager efter en uoverensstemmelse mellem visse medlemsstater i Den Europæiske Union angående udstedelse af markedsføringstilladelse for lægemidlet Sabumalin. 
The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sabumalin.
Begrundelsen for indbringelsen var betænkeligheder ved, at der ikke forelå tilstrækkelige data, som viste, at Sabumalin svarer til referencelægemidlet. 
The grounds for the referral were concerns regarding that there was not enough data showing that Sabumalin is equivalent to the reference medicine.
Sabumalin kan også anvendes til at forebygge astmasymptomer udløst af anstrengelse eller andre udløsende faktorer som husstøv, pollen, katte, hunde og cigaretrøg. 
It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke.
Spørgsmål og svar vedrørende indbringelsen af sagen om Sabumalin salbutamol, inhalationsspray med afmålte doser, 100 μg/dosis 
Questions and answers on the referral for Sabumalin salbutamol, metered dose aerosol inhaler, 100 μg/dose
Hexal AG indgav den 5. december 2006 ansøgningen for Sabumalin gennem en decentraliseret procedure til den svenske regulerende myndighed for lægemidler. 
Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at den gavnlige virkning af Sabumalin er større end risiciene, og at der kan udstedes markedsføringstilladelse i Sverige samt i EU-medlemsstaterne Belgien, Danmark, Estland, Finland, Tyskland, Grækenland, Ungarn, Italien, Letland, Litauen, Nederlandene, Polen, Portugal, Slovenien, Spanien og Det Forenede Kongerige samt i Norge. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Sabumalin outweigh its risks, and that the marketing authorisation can be granted in Sweden as well as in the following Member States of the European Union: Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom.
Sabumalin anvendes til symptomlindring og bør ikke udsætte anvendelsen af inhalerede steroider. 
Sabumalin is used to relieve symptoms, and its use should not delay the use of inhaled steroids.
Sabumalin anvendes til behandling af vejrtrækningsbesvær forårsaget af astma og kronisk obstruktiv lungesygdom (KOL). 
Sabumalin is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD).
Sag indbragt med den begrundelse, at der foreligger en potentiel alvorlig risiko for folkesundheden, i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer. 
Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Sabumalin er et generisk lægemiddel. 
Sabumalin is a ‘generic medicine'.
Salbutamol er en beta2-adrenerg receptoragonist. 
Salbutamol is a beta2-adrenergic receptor agonist.
Der blev også rejst betænkeligheder ved opbevaringen af inhalatoren og ved, om den position, inhalatoren holdes i ved indgivelsen, har indflydelse på virkningen. 
Concerns were also raised regarding how to store the inhaler and the effect of the orientation of the inhaler on the delivery of the medicine.
Disse medlemsstater kunne ikke nå til enighed, og den svenske regulerende myndighed indbragte sagen for CHMP den 4. marts 2008. 
On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.
Det betyder, at salbutamol aktiverer kroppens beta2receptorer. 
This means that salbutamol activates the beta2receptors in the body.
Når salbutamol gives ved inhalation som i Sabumalin, aktiveres beta2-receptorerne direkte i luftvejene. 
When given by inhalation as in Sabumalin, salbutamol directly activates the beta2-receptors in the respiratory system.
Sabumalin er et lægemiddel i en inhalationsspray. 
Sabumalin is a medicine in a pressurised inhaler that contains salbutamol as active substance.
30. maj 2008, 20. oktober 2008 
Company responses provided on: 30 May 2008, 20 October 2008 Opinion date:
EMA's procedurenummer 
EMA Number
Styrke Lægemiddelform Administration Indre emballage 
Strength Pharmaceutical Form Route of Administration
MF (EU)-nummer 
MA (EU) number (Invented) Name
Indhold (Koncentration) 
Content (concent ration)
Hvorfor blev lægemidlet undersøgt? 
Why was the medicine reviewed?
Spraygelen anvendes på huden i de berørte områder for at lindre smerte og hævelse som følge af traumer i små og mellemstore led samt det omkringliggende væv. 
The spray gel is applied on the skin of affected areas to relieve pain and swelling due to trauma in small and medium joints and surrounding tissues.
MIKA Pharma GmbH har anmodet om, at den markedsføringstilladelse for Diclofenac Sodium Spray Gel 4 %, som Det Forenede Kongerige (referencemedlemsstaten) udstedte i 2001, og som efterfølgende blev udstedt af Østrig, Estland, Ungarn, Irland, Letland, Litauen og Slovenien, også anerkendes i Tyskland, Italien og Spanien (de berørte medlemsstater). 
MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK (the ‘reference Member State') in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain (the ‘concerned Member States').
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den britiske lægemiddelstyrelse indbragte den 4. april 2018 sagen for EMA med henblik på voldgift. 
However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 4 April 2018.
Indbringelsen skyldtes Tysklands og Spaniens påstand om, at de data, som virksomheden havde fremlagt, ikke var tilstrækkelige til at påvise, at lægemidlet er effektivt til at behandle ledsmerter og hævelse. 
The grounds for the referral were concerns raised by Germany and Spain that the data provided by the company were not sufficient to show that the product was effective at treating joint pain and swelling.
Den 15. november 2018 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Diclofenac Sodium Spray Gel 4% efter en uoverensstemmelse blandt medlemsstaterne om dets godkendelse. 
On 15 November 2018, the European Medicines Agency completed a review of Diclofenac Sodium Spray Gel 4% following a disagreement among EU Member States regarding its authorisation.
Hvad er Diclofenac Sodium Spray Gel 4%? 
What is Diclofenac Sodium Spray Gel 4%?
Agenturet var også af den holdning, at på trods af, at effekten af diclofenac og andre NSAID'er anvendt på huden er forholdsvis beskeden, har disse lægemidler været godkendt i årtier, og sikkerheden ved dem er velkendt. 
The Agency also considered that, although the effectiveness of diclofenac and other NSAIDs applied to the skin is somewhat modest, these medicines have been authorised and used for decades and their safety is not in question.
Diclofenac Sodium Spray Gel 4% indeholder det aktive stof diclofenac, der tilhører gruppen af ikkesteroide antiinflammatoriske lægemidler (NSAID'er). 
Diclofenac Sodium Spray Gel 4% contains the active substance diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Europa-Kommissionen traf en retligt bindende afgørelse for hele EU om markedsføringstilladelsen for Diclofenac Sodium Spray Gel 4% den 18. januar 2019. 
The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diclofenac Sodium Spray Gel 4% on 18/01/2019.
Eftersom Diclofenac Sodium Spray Gel 4% absorberes på samme måde som andre diclofenac-holdige lægemidler, der anvendes på huden, og den understøttende undersøgelse påviste en effekt, der svarer til effekten af andre diclofenac-holdige lægemidler i den offentliggjorte litteratur, fandt agenturet, at det var acceptabelt at anvende offentliggjorte data for effekten og sikkerheden af andre diclofenacholdige lægemidler til at understøtte brugen af Diclofenac Sodium Spray Gel 4%. 
Since Diclofenac Sodium Spray Gel 4% is absorbed in a similar way to other diclofenac medicines applied to the skin and the supporting study demonstrated an effect similar to that of other diclofenac medicines in the published literature, the Agency considered that it was acceptable to use published data on the effectiveness and safety of other diclofenac medicines to support the use of Diclofenac Sodium Spray Gel 4%.
Virksomheden fremlagde også resultaterne af en undersøgelse, der indikerede, at Diclofenac Sodium Spray Gel 4% er effektivt til at reducere hævelse i led og lindre smerter. 
The company also provided the results of a study indicating that Diclofenac Sodium Spray Gel 4% is effective at reducing joint swelling and relieving pain.
Agenturet konkluderede, at fordelene ved Diclofenac Sodium Spray Gel 4% opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Det Forenede Kongerige, kan anerkendes i andre EUmedlemsstater, hvor virksomheden har ansøgt om en markedsføringstilladelse. 
The Agency concluded that the benefits of the medicine outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Gennemgangen af Diclofenac Sodium Spray Gel 4% blev iværksat på anmodning fra Det Forenede Kongerige i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF Gennemgangen blev foretaget af EMA's Udvalg for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker. 
The review of Diclofenac Sodium Spray Gel 4% was initiated at the request of the United Kingdom under Article 29(4) of Directive 2001/83/EC.
Overordnet set fandt agenturet, at den samlede mængde data, som virksomheden havde fremlagt, var tilstrækkelig til at dokumentere, at Diclofenac Sodium Spray Gel 4% er effektivt til at behandle hævede led og smerter som følge af traumer. 
Overall, the totality of the data provided by the company was considered sufficient to demonstrate that Diclofenac Sodium Spray Gel 4% is effective at treating joint swelling and pain due to trauma.
Desuden var der et behov for yderligere at begrunde anvendelsen af data fra den offentliggjorte litteratur vedrørende andre diclofenac-holdige lægemidler til at påvise fordelene ved Diclofenac Sodium Spray Gel 4%. 
In addition, the use of data from the published literature obtained with other diclofenac medicines to demonstrate the benefits of Diclofenac Sodium Spray Gel 4% needed to be further justified.