natgillin/translations-raw huggingface dataset:
Opløsning til injektion/Infusion 
Solution For Injection/Infusion
Oral opløsning 
Oral Solution
Suppositorie 
Suppository
Novalgine I.M./I.V. 
Sanofi Belgium Novalgine I.M./I.V.
Sanofi Belgium 
Sanofi Belgium Novalgine
Stada Arzneimittel Ag 
Stada Arzneimittel Ag Metamistad
Sanofi Rumænien Srl 
Sanofi Romania Srl
Pulver til oral opløsning 
Powder For Oral Solution
Sanofi-Aventis Slovakiet Sro 
Sanofi-Aventis Slovakia Sro
Kodein Phosphat Sesquihydrat 0.03g in form of Kodein Phosphat Hemihydrat 0.02873g, Metamizolnatrium 0.9g, Caffein og Natriumbenzoat 0.1g / Suppositorie 
Codeine Phosphate Sesquihydrate 0.03g in form of Codeine Phosphate Hemihydrate 0.02873g, Metamizole Sodium 0.9g, Caffeine And Sodium Benzoate 0.1g / suppository
Filmovertrukket Tablet 
Film-Coated Tablet
Goodwill Pharma Ltd 
Goodwill Pharma Ltd Metapyrin
Metamizolnatrium 0.9g Suppositorie, Caffein 0.05g Suppositorie, Kodein Phosphat Hemihydrat 0.03g Suppositorie 
Metamizole Sodium 0.9g Suppository, Caffeine 0.05g Suppository, Codeine Phosphate Hemihydrate 0.03g Suppository
Chemax Pharma Ltd 
Chemax Pharma Ltd Диалгин
Metamizolnatriummonohydrat 0.525g/ml 
Metamizole Sodium Monohydrate 0.525g/ml
Metamizolnatrium 1g Suppositorie Suppositorie 
Metamizole Sodium 1g Suppository
Metamizolnatriummonohydrat 25mg Drop 
Metamizole Sodium Monohydrate 25mg Drop
Pitofenon Hydrochlorid 10mg, Metamizolnatrium 1g 
Hydrochloride 10mg, Metamizole Sodium 1g
Metamizolnatrium 200mg Suppositorie 
Metamizole Sodium 200mg Suppository
Metamizolnatrium 450mg Tablet, Caffein 50mg Tablet 
Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet
Pulver til oral opløsning i brev 
Powder For Oral Solution In Sachet
Drotaverin Hydrochlorid 40mg Tablet, Metamizolnatrium 400mg Tablet, Caffein 60mg Tablet 
Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet
Metamizolnatrium 300mg Tablet, Paracetamol 200mg Tablet, Caffein 30mg Tablet, Kodein Phosphat 20mg Tablet 
Metamizole Sodium 300mg Tablet, Paracetamol 200mg Tablet, Caffeine 30mg Tablet, Codeine Phosphate 20mg Tablet
Metamizolnatrium 1g/2ml 
Metamizole Sodium 1g/2ml
Thiamin Hydrochlorid 38.75mg Tablet, Metamizolnatrium 500mg Tablet, Caffein 50mg Tablet 
Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet
Metamizolnatrium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffein 50mg Tablet, Kodein Phosphat Hemihydrat 10mg Tablet 
Metamizole Sodium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffeine 50mg Tablet, Codeine Phosphate Hemihydrate 10mg Tablet
Metamizolnatrium Kalceks 
Metamizol Kalceks
Metamizolnatriummonohydrat 2,5 g/5 ml 
Metamizole Sodium Monohydrate 2,5 g/5 ml
Cyanocobalamin 0.5mg Tablet, Metamizolnatrium 500mg Tablet, Thiamin Nitrat 75mg Tablet, Pyridoxin Hydrochlorid 50mg Tablet 
Cyanocobalamin 0.5mg Tablet, Metamizole Sodium 500mg Tablet, Thiamine Nitrate 75mg Tablet, Pyridoxine Hydrochloride 50mg Tablet
Kodein Phosphat Sesquihydrat 0.03g Suppositorie, Metamizolnatrium 0.09g Suppositorie, Caffein og Natriumbenzoat 0.1g Suppositorie, Kodein Phosphat Hemihydrat 0.02873g Suppositorie 
Codeine Phosphate Sesquihydrate 0.03g Suppository, Metamizole Sodium 0.09g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository, Codeine Phosphate Hemihydrate 0.02873g Suppository
Metamizolnatriummonohydrat 1000mg Suppositorie 
Metamizole Sodium Monohydrate 1000mg Suppository
Metamizolnatrium 500mg Tablet, Triacetonamin Tosilat 20mg Tablet 
Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet
Metamizolmagnesium 2g/5ml 
Metamizole Magnesium 2g/5ml
Metamizolmagnesium 575mgg 
Metamizole Magnesium 575mgg
Metamizolmagnesium 500mg Kapsel 
Metamizole Magnesium 500mg Capsule
Intravenøs anvendelse 
Parenteral Use
Laboratorios Normon, S.A. Metamizol Normon Metamizolmagnesium 2g/5ml 
Metamizol Normon Metamizole Magnesium 2g/5ml
Metamizolnatrium 250mg Tablet, Hyoscin ButylBromid 10mg Tablet 
Scopolan Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg
Metamizolnatrium 300mg Suppositorie 
Metamizole Sodium 300mg Suppository
Metamizolnatrium 100mg Suppositorie 
Metamizole Sodium 100mg Suppository
Metamizolnatriummonohydrat 500mg/ml, Pitofenon Hydrochlorid 5mg/ml 
Metamizole Sodium Monohydrate 500mg/ml, Pitofenone Hydrochloride 5mg/ml
Pitofenon Hydrochlorid 5mg, Metamizolnatrium 500mg 
Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg
Intramuskulær anvendelse | Intravenøs anvendelse | Parenteral anvendelse 
Intramuscular Use | Intravenous Use
Metamizolmagnesium 2000mg /5ml 
Metamizole Magnesium 2000mg /5ml
Metamizolnatrium 500mg/ml 
Metamizole 500mg/ml
Metamizolmagnesium Hexahydrat 575mg Kapsel 
Metamizole Magnesium Hexahydrate 575mg Capsule
Metamizolnatriummonohydrat 527mg Tablet, Pitofenon Hydrochlorid 5.25mg Tablet, Fenpiverinium Bromid 0.1mg Tablet 
Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Pitofenon Hydrochlorid 2mg/ml, Fenpiverinium Bromid 0.02mg/ml, Metamizolnatrium 500mg/ml 
Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml, Metamizole Sodium 500mg/ml
Metamizol 575mg Kapsel 
Metamizole 575mg Capsule
Stadapharm Gmbh 
Stadapharm Gmbh Metamizol Stada
Teva Czech Industries s.r.o Algifen Neo 
Teva Czech Industries S.R.O
Metamizolnatrium 500mg 
Metamizole Sodium 500mg
Metamizol Heumann Metamizolnatriummonohydrat 500mg/ml 
Metamizol Heumann Metamizole Sodium Monohydrate 500mg/ml
Pitofenon Hydrochlorid 2mg/ml, Metamizolnatrium 500mg/ml 
Hydrochloride 2mg/ml, Metamizole Sodium 500mg/ml
Abz-Pharma Gmbh 
Abz-Pharma Gmbh Novaminsulfon
Aliud Pharma Gmbh 
Aliud Pharma Gmbh Metamizol Al
Analgin Sopharma Metamizolnatrium 500mg Tablet 
Metamizol Sintocalmin Metamizole 500mg Tablet
Pitofenon Hydrochlorid 5mg Tablet, Fenpiverinium Bromid 0.1mg Tablet, Metamizolnatrium 500mg Tablet 
Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet
Bruse Tablet 
Coated Tablet
Metamizol Heumann Metamizolnatriummonohydrat 500mg Tablet 
Metamizol Heumann Metamizole Sodium Monohydrate 500mg
Laboratorios Alter, S.A. 
Laboratorios Normon, S.A.
Pitofenon Hydrochlorid 5mg/ml, Metamizolnatrium 500mg/ml 
Hydrochloride 5mg/ml, Metamizole Sodium 500mg/ml
Metamizolmagnesium 575mg Kapsel 
Metamizole Magnesium 575mg Capsule
Metamizolnatriummonohydrat 500mg Tablet, Pitofenon Hydrochlorid 5mg Tablet, Fenpiverinium Bromid 0.1mg Tablet 
Metamizole Sodium Monohydrate 500mg Tablet, Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Novaminsulfon Metamizolnatrium 500g/ml 
Metamizole Sodium 500g/ml
Pitofenon Hydrochlorid 5mg Tablet, Metamizolnatrium 500mg Tablet, Fenpipramid Bromomethylat 0.1mg Tablet 
Hydrochloride 5mg Tablet, Metamizole Sodium 500mg Tablet, Fenpipramide Bromomethylate 0.1mg Tablet
Pitofenon Hydrochlorid 10mg/5ml, Fenpiverinium Bromid 0.1mg/5ml, Metamizolnatrium 2500mg/5ml 
Fenpiverinium Bromide 0.1mg/5ml, Metamizole Sodium 2500mg/5ml
Диалгин Джуниор Metamizolnatriummonohydrat 250mg Brev 
Chemax Pharma Ltd Диалгин Джуниор Metamizole Sodium Monohydrate 250mg
Metamizolnatriummonohydrat 1000mg Brev 
Metamizole Sodium Monohydrate 1000mg Sachet
Novalgine 
Zaklady
Диалгин Експрес Metamizolnatrium 500mg Brev, Caffein 50mg Brev 
Metamizole Sodium 500mg Sachet, Caffeine 50mg Sachet
Laboratorios Normon, S.A. Metamizol Normon Metamizolmagnesium 575mg Kapsel 
Metamizol Normon Metamizole Magnesium 575mg Capsule
Algi-Mabo Adultos Metamizolmagnesium 1000mg Suppositorie 
Metamizole Magnesium 1000mg Suppository
Metamizolnatriummonohydrat 0.5g/ml, Pitofenon Hydrochlorid 2mg/ml, Fenpiverinium Bromid 0.02mg/ml 
Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml
Laboratorios Cinfa, S.A. 
Laboratorios Cinfa, S.A. Metamizol Cinfa
Metamizol Aristo Metamizolnatriummonohydrat 500mg/ml 
Metamizol Will-Pharma Metamizole Sodium Monohydrate 500mg/ml
Metamizole Abz 
Abz-Pharma Gmbh Metamizole Abz
Pharma Gmbh 
Pharma Gmbh Metagelan
Metamizol Aristo Metamizolmagnesium 575mg Kapsel 
Metamizol Kern Pharma Metamizole Magnesium 575mg Capsule
Fortæl os hvad du mener om disse oplysninger ved at besvare nogle få spørgsmål - det vil kun tage et par minutter af din tid: 
Please tell us what you think about this information by answering a few questions - it will only take a couple of minutes of your time:
Tre af tilfældene var dødelige. 
Three of the cases were fatal.
Fortæl os, hvor nyttige du fandt disse oplysninger 
Tell us how well we did with this information
Størstedelen af patienterne i EU er blevet behandlet i Tyskland. 
The majority of EU patients have been treated in Germany.
EMA vil afslutte sin grundige gennemgang og offentliggøre det endelige resultat. 
EMA will complete its in-depth review and make public the final outcome.
Den 7. marts 2018 EMA/134289/2018 
8 March 2018 EMA/155367/2018
Dokumentation for risiko for alvorlige inflammatoriske hjernesygdomme 
Evidence indicates risk of serious inflammatory brain disorders
Gennemgangen af Zinbryta blev indledt den 26. februar 2018 på anmodning af Europa-Kommissionen i henhold til artikel 20 i forordning (EF) nr. 726/2004. 
The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.
Størstedelen af tilfældene indtraf inden for otte måneder efter initiering af behandlingen. 
Most cases occurred within 8 months of starting treatment.
• Zinbryta vil blive tilbagekaldt fra apoteker og hospitaler i hele EU. 
• Zinbryta will be recalled from pharmacies and hospitals across the EU.
Disse kan være tegn på en reaktion over for Zinbryta. 
These could be signs of a reaction to Zinbryta.
Zinbryta blev godkendt i 2016 til behandling af tilbagevendende former af multipel sklerose. 
Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Sådanne reaktioner kan indtræffe i seks måneder, efter at behandlingen er ophørt. 
These reactions can occur for 6 months after treatment has been stopped.
Til dato er over 8.000 patienter verden over blevet behandlet med Zinbryta. 
To date over 8,000 patients have been treated with Zinbryta worldwide.
Oplysninger til sundhedspersonale 
Information for healthcare professionals
Zinbryta kan desuden have sammenhæng med svære immunreaktioner, der berører flere andre organer. 
Zinbryta may also be linked to severe immune reactions affecting several other organs.
Den indledende gennemgang foretages af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som vil fremsætte et sæt anbefalinger. 
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
• Lægen vil foretage regelmæssige blodprøver i op til seks måneder efter at have stoppet behandlingen med henblik på at kontrollere for bivirkninger. 
• Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
Efter en gennemgang i 2017 af lægemidlets virkninger på leveren blev dets anvendelse begrænset til patienter, hos hvem der er forsøgt mindst to andre sygdomsmodificerende behandlinger, og som ikke kan behandles med andre midler mod multipel sklerose. 
Following a 2017 review of the medicine's effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.
Der bør følges op på patienter, hvis behandling standses, i mindst 6 måneder (se nærmere herom nedenfor). 
Patients stopping treatment must be followed up for at least 6 months (see more details below).
En indledende gennemgang af den foreliggende dokumentation tyder på, at de iagttagne immunreaktioner i de indberettede tilfælde kan have sammenhæng med anvendelsen af Zinbryta. 
A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta.
Virksomheden, der markedsfører Zinbryta (Biogen Idec Ltd), har allerede frivilligt anmodet om tilbagekaldelse af lægemidlets markedsføringstilladelse og underrettet EMA om, at den har til hensigt at standse de kliniske studier. 
The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine's marketing authorisation and has informed EMA of its intention to stop clinical studies.
Den foreliggende dokumentation peger desuden på, at Zinbryta kan have sammenhæng med andre immunmedierede lidelser, såsom bloddyskrasier, thyroiditis eller glomerulonefritis. 
Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.
Sundhedspersoner bør straks kontakte de patienter, der på nuværende tidspunkt er i behandling med Zinbryta, og bør ophøre med behandlingen og tage stilling til alternativer. 
Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives.
Hidtil har EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) gennemgået 12 tilfælde af immunmedierede inflammatoriske lidelser, herunder encephalitis. 
To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis.
En tidligere PRAC-gennemgang i 2017 viste, at der kan indtræffe uforudsigelig og potentielt dødelig immunmedieret leverskade med Zinbryta i op til seks måneder efter behandlingens ophør, og konkluderede, at der bør følges op på patienter, der ophører med behandlingen. 
A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded that patients stopping treatment should be followed up.
Start spørgeundersøgelsen 
Start the survey
• Sig det straks til lægen, hvis du har eller oplever symptomer som vedvarende høj temperatur, svær hovedpine, kvalme, træthed, gulfarvning af hud eller øjne, og opkastning. 
• Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting.
• Tag ikke flere injektioner af Zinbryta. 
• Do not take another injection of Zinbryta.
Det Europæiske Lægemiddelagentur (EMA) har anbefalet, at lægemidlet mod multipel sklerose Zinbryta (daclizumab beta) øjeblikkelig suspenderes og tilbagekaldes efter 12 indberetninger om alvorlige inflammatoriske hjernesygdomme i hele verden, herunder encephalitis og meningoencephalitis. 
On 6 March 2018, the European Medicines Agency (EMA) recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis.
• Bed patienterne om straks at indberette symptomer på leverskader, såsom langvarig feber, svær hovedpine, træthed, gulsot, kvalme eller opkastning. 
• Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting.
• Hvis du deltager i et klinisk studie med Zinbryta, skal du kontakte den læge, der behandler dig i studiet. 
• If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
• Hvis du er i behandling med Zinbryta, skal du kontakte lægen for at drøfte din behandling. 
• If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
For at beskytte patienternes helbred anbefaler EMA øjeblikkelig suspendering af lægemidlets markedsføringstilladelse i EU og tilbagekaldelse af partier fra apoteker og hospitaler. 
To protect patients' health, the marketing authorisation in the EU of Zinbryta is now suspended and batches are to be recalled from pharmacies and hospitals.
Ingen nye patienter bør sættes i behandling med Zinbryta. 
No new patients should start treatment with Zinbryta.
Overvej andre behandlinger efter omstændighederne. 
Consider alternative treatments as appropriate.
PRAC's anbefaling om at suspendere Zinbryta og tilbagekalde produktet sendes til EuropaKommissionen med henblik på en retligt bindende afgørelse. 
The PRAC's recommendation to suspend Zinbryta and recall the product was sent to the European Commission, which issued a legally binding decision on 8 March 2018.
• Sæt ikke nye patienter i behandling med Zinbryta. 
• Do not start any new patients on Zinbryta.
alt efter hvad der er klinisk indiceret, i op til seks måneder efter den sidste dosis Zinbryta. 
• Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of Zinbryta.
• Kontakt snarest muligt de af dine patienter, der på nuværende tidspunkt er i behandling med 
• Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment.
De harmoniserede områder er følgende: 
The areas harmonised include:
Den ændrede information til læger og patienter findes her. 
The amended information to doctors and patients is available here.
Nasonex og relaterede navne markedsføres i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Kroatien, Cypern1, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige samt Island og Norge. 
Nasonex and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus1, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Europa-Kommissionen vedtog en afgørelse, der er retligt bindende i hele EU, den 19. januar 2015. 
The European Commission issued an EU-wide legally binding decision to implement these changes on 19 January 2015.
Den virksomhed, der markedsfører disse lægemidler, er Merck Sharp & Dohme. 
The company that markets these medicines is Merck Sharp & Dohme.
Hvad er Nasonex? 
What is Nasonex?
Den 19. januar 2015 EMA/39886/2015 
EMA/39886/2015
1 Nasonex markedsføres i Cypern i henhold til artikel 126a i direktiv 27/2004/EF, som giver mulighed for, at et land tillader markedsføring af et lægemiddel i en begrænset årrække, når det er berettiget af hensyn til folkesundheden. 
1 Nasonex is marketed in Cyprus under Art.126a of Directive 27/2004 EC, which allows a country to place a product in the market for justified public health reasons for a limited number of years.
Hvorfor blev Nasonex vurderet igen? 
Why was Nasonex reviewed?
Spørgsmål og svar om Nasonex og relaterede navne (mometasonfuroat, næsespray, 50 µg) 
Questions and answers on Nasonex and associated names (mometasone furoate, 50 microgram, nasal spray)
Nasonex indeholder det aktive stof mometasonfuroat. 
Nasonex contains the active substance mometasone furoate.
Den 20. november 2014 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Nasonex og relaterede navne. 
On 20 November 2014, the European Medicines Agency completed a review of Nasonex and associated names.
• behandling af næsepolypper hos voksne (på 18 år og derover). 
• Treatment of nasal polyps in adults (aged 18 years and older).
Udvalget fastslog desuden, at Nasonex ikke længere burde anbefales til behandling af akut bihulebetændelse, som var godkendt i visse medlemsstater, da de foreliggende oplysninger til dokumentation heraf blev betragtet som begrænsede. 
The Committee also agreed that Nasonex should no longer be recommended to treat acute sinusitis, which was authorised in some Member States, because the available data to support this use were considered limited.
På denne baggrund indbragte Europa-Kommissionen den 17. september 2013 sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Nasonex i EU. 
In view of this, on 17 September 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Nasonex in the EU.
Nasonex og relaterede navne har været godkendt i EU's medlemsstater via nationale procedurer siden 1997. 
Nasonex and associated names have been authorised in EU Member States through national procedures since
Efter harmonisering af indikationerne harmoniserede CHMP også doseringsanbefalingerne. 
Having harmonised the indications, the CHMP also harmonised recommendations on the doses.
CHMP konkluderede, at Nasonex ikke måtte bruges i følgende tilfælde: 
The CHMP agreed to that Nasonex must not be used in:
Dette gælder punkt 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.6 (fertilitet, graviditet og amning), 4.8 (bivirkninger) og 5.1 (farmakodynamiske egenskaber). 
The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
Efter gennemgang af de oplysninger, der dokumenterer lægemidlets anvendelse, fandt CHMP, at Nasonex kunne anvendes til følgende: 
After reviewing the available data supporting the medicine's use, the CHMP agreed that Nasonex can be used for the following:
• ved kendt allergi (hypersensitivitet) over for mometasonfuroat eller andre af indholdsstofferne 
• Patients with known hypersensitivity (allergy) to mometasone furoate or to any other ingredients.
Etiketteringen og indlægssedlen blev ligeledes revideret svarende til ændringerne i produktresuméet. 
The labelling and package leaflet were also revised in line with the changes to the SmPC.
• behandling af symptomerne på sæsonbetinget allergisk eller tilbagevendende rhinitis hos voksne og børn på tre år og derover 
• Treatment of symptoms of seasonal allergic or perennial rhinitis in adults and in children aged three and above.
• ved ubehandlet eller lokal indvendig infektion i næsen, såsom herpes 
• Patients who have an untreated and localised infection, such as herpes, affecting the inside of the nose.
Desuden bruges det hos voksne til behandling af udvækster af næseslimhinden (polypper). 
In addition, it is used in adults to treat nasal polyps (growths in the lining of the nose).
Det bruges hos voksne og børn på tre år og derover til behandling af symptomerne på sæsonbetinget allergisk eller tilbagevendende rhinitis (betændelse i næsepassagerne, som forårsages af lejlighedsvis eller vedvarende allergi). 
Nasonex is an anti-inflammatory medicine that is used in adults and children from three years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by occasional or long-term allergy).
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der var behov for harmonisering af produktinformationen for Nasonex og relaterede navne i EU. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Nasonex and associated names in the European Union (EU).
Det fås som næsespray. 
It is available as a nasal spray.
Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, som det fremgår af forskellene i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres. 
As Nasonex has been authorised in the EU via national procedures, this has led to divergences across Member States in the way the medicine can be used, as seen in differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
• efter nylige næseoperationer eller sår i næsen, idet Nasonex kan påvirke sårhelingen. 
• Patients who have recently undergone nose surgery or who have a wound in the nose, because