FrancophonIA/ELRC3.0 huggingface dataset:
English: Week 4 (day 22-28): Take one 20 mg tablet per day (dark pink, oval shaped) for 7 days.
Danish: Tag én 20 mg tablet dagligt (mørkt rosa, oval) i 7 dage.
English: Uncommon Fungal infections
Danish: Infektioner og parasitære sygdomme Ikke almindelig Svampeinfektioner Immunsystemet
English: HDPE bottle.
Danish: HDPE-tabletbeholder.
English: Nemdatine 10 mg film-coated tablets:
Danish: Nemdatine 10 mg filmovertrukne tabletter:
English: Nemdatine 10 mg film-coated tablets
Danish: Nemdatine 10 mg filmovertrukne tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg memantinhydrochlorid svarende til 4,15 mg memantin.
English: Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172).
Danish: Tabletovertræk (Opadry II Pink 33G240000): Hypromellose 6cP, titandioxid (E171), laktosemonohydrat, macrogol 3350, triacetin og rød og gul jernoxid (E172).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 15 mg memantinhydrochlorid svarende til 12,46 mg memantin.
English: Nemdatine 5 mg film-coated tablets:
Danish: Nemdatine 5 mg filmovertrukne tabletter:
English: Infections and infestations
Danish: Betændelse i bugspytkirtlen
English: The patient should take one 5 mg film-coated tablet per day (white, oval-shaped) for 7 days.
Danish: Patienten bør tage én 5 mg filmovertrukket tablet pr. dag (hvid, oval) i 7 dage.
English: Orange, oval shaped, biconvex film-coated tablets, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Danish: Orange, ovale, bikonvekse filmovertrukne tabletter med en størrelse på 11,4 mm x 6,4 mm og præget med “M15” på den ene side.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg memantinhydrochlorid svarende til 16.62 mg memantin.
English: Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Danish: Orange, oval, bikonveks filmovertrukket tablet med en størrelse på 11,4 mm x 6,4 mm og præget med “M15” på den ene side.
English: 7 film-coated tablets of Nemdatine 10 mg
Danish: 7 filmovertrukne Nemdatine 10 mg tabletter
English: Nemdatine 15 mg film-coated tablets
Danish: Nemdatine 15 mg filmovertrukne tabletter
English: Pack sizes Blister packs: 42 and 98 film-coated tablets.
Danish: Pakningsstørrelser Blisterpakker: 42 og 98 filmovertrukne tabletter.
English: Week 1 (day 1-7): Take one 5 mg tablet once a day (white, oval-shaped) for 7 days.
Danish: Tag én 5 mg tablet én gang dagligt (hvid, oval) i 7 dage.
English: Nemdatine 5 mg film-coated tablets
Danish: Nemdatine 5 mg filmovertrukne tabletter
English: Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Danish: Mørkrosa, oval, bikonveks filmovertrukket tablet med en størrelse på 12,6 mm x 7 mm og præget med “M20” på den ene side.
English: Dark pink, oval shaped, biconvex film-coated tablets, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Danish: Mørkrosa, ovale, bikonvekse filmovertrukne tabletter med en størrelse på 12,6 mm x 7 mm og præget med “M20” på den ene side.
English: Half a 10 mg tablet
Danish: En halv tablet à 10 mg
English: White, capsule-shaped, biconvex film-coated tablets, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Danish: Hvide, kapselformede, bikonvekse filmovertrukne tabletter med en størrelse på 9,8 mm x 4,9 mm med delekærv og præget med “M 10” på siden med delekærv.
English: White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5”
Danish: Hvid, oval, bikonveks filmovertrukket tablet med en størrelse på 8 mm x 4,5 mm, præget ”M5” på den ene side.
English: Nemdatine 20 mg film-coated tablets memantine hydrochloride
Danish: Nemdatine 20 mg filmovertrukne tabletter memantinhydrochlorid
English: White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Danish: Hvid, kapselformet, bikonveks filmovertrukket tablet med en størrelse på 9,8 mm x 4,9 mm med delekærv og præget med “M 10” på siden med delekærv.
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Nemdatine 20 mg tabletter memantinhydrochlorid
English: Week 3 (day 15-21): Take one 15 mg tablet once a day (orange, oval shaped) for 7 days.
Danish: Tag én 15 mg tablet én gang dagligt (orange, oval) i 7 dage.
English: White, oval shaped, biconvex film-coated tablets, 8 mm x 4.5 mm in size, with the marking “M5”
Danish: Hvide, ovale, bikonvekse filmovertrukne tabletter med en størrelse på 8 mm x 4,5 mm og præget med “M5” på den ene side.
English: 7 film-coated tablets of Nemdatine 15 mg
Danish: 7 filmovertrukne Nemdatine 15 mg tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Inside
Danish: ÆSKE OG PAPOMSAG TIL 28 TABLETTER - BEHANDLINGSSTARTPAKKE - 4-UGERS BEHANDLINGSPLAN - Indvendig
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 10 mg tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Nemdatine 10 mg tabletter memantinhydrochlorid
English: Possible side effects
Danish: Dette omfatter bivirkninger,
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg film-coated tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Nemdatine 20 mg filmovertrukne tabletter memantinhydrochlorid
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 5 mg tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Nemdatine 5 mg tabletter memantinhydrochlorid
English: Nemdatine 5 mg film-coated tablets memantine hydrochloride
Danish: Nemdatine 5 mg filmovertrukne tabletter memantinhydrochlorid
English: Nemdatine 10 mg film-coated tablets memantine hydrochloride
Danish: Nemdatine 10 mg filmovertrukne tabletter memantinhydrochlorid
English: Nemdatine 15 mg film-coated tablets memantine hydrochloride
Danish: Nemdatine 15 mg filmovertrukne tabletter memantinhydrochlorid
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 15 mg tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Nemdatine 15 mg tabletter memantinhydrochlorid
English: Uncommon Vomiting Not known Pancreatitis2
Danish: Almindelig Forstoppelse Ikke almindelig Opkastning Ikke kendt
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 10 mg film-coated tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Nemdatine 10 mg filmovertrukne tabletter memantinhydrochlorid
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 5 mg film-coated tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Nemdatine 5 mg filmovertrukne tabletter memantinhydrochlorid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/018
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/13/824/018
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 15 mg film-coated tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Nemdatine 15 mg filmovertrukne tabletter memantinhydrochlorid
English: What Nemdatine looks like and contents of the pack Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side
Danish: Nemdatine 10 mg filmovertrukne tabletter (tabletter) er hvide, kapselformede, bikonvekse, har en størrelse på 9,8 mm x 4,9 mm og delekærv og er præget “M 10” på siden med delekærven
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/13/824/021
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/019
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/13/824/019
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/13/824/020
English: Week 2 (day 8-14): Take one 10 mg tablet once a day (white, capsule shaped) for 7 days.
Danish: Tag én 10 mg tablet én gang dagligt (hvid, kapselformet) i 7 dage 3. uge (dag 15-21):
English: Not known Psychotic reactions
Danish: Ikke almindelig Opkastning Ikke kendt
English: • The ECG monitoring recommendations.
Danish: • Anbefalingerne for EKG-overvågning.
English: The Member States shall agree the final educational material with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Danish: Medlemslandene skal nå til enighed med indehaveren af markedsføringstilladelsen (MAH) om det endelige uddannelsesmateriale, før produktet lanceres i deres territorier.
English: • In Member States where the EU safety registry will be available, the educational materials should include details on the registry and how to enter patients in it.
Danish: • I medlemslande, hvor EU-sikkerhedsregistret vil være tilgængeligt, skal uddannelsesmaterialerne inkludere detaljer om registret og om, hvordan patienterne registreres i det.
English: • The existence and scope of the pregnancy register and details of how to enter patients in it.
Danish: • Eksistensen af og omfanget af graviditetsregistret og detaljer om, hvordan patienterne registreres i det.
English: • That there is a potential risk of teratogenicity and so Eurartesim should not be used in situations where other suitable and effective anti-malarials are available.
Danish: • At der kan være risiko for teratogenicitet, og derfor skal Eurartesim ikke anvendes i situationer, hvor andre hensigtsmæssige og effektive midler mod malaria er tilgængelige.
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Eurartesim a healthcare professional educational pack containing the following:
Danish: Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen (MAH) vil sørge for, at alle læger, som forventes at ordinere eller anvende Eurartesim, får udleveret en undervisningspakke for sundhedspersonale, der indeholder følgende:
English: • That piperaquine absorption is increased in the presence of food, therefore to reduce this risk of QTc interval prolongation, the patients should be advised to take the tablets with water, without food, no less than three hours after the last food intake.
Danish: • At absorptionen af piperaquin forøges under tilstedeværende af fødevarer; for at reducere denne risiko for QTc-forlængelse skalpatienterne derfor rådes til at tage tabletterne sammen med vand, uden føde, højst 3 timer efter den sidste indtagelse af fødevarer.
English: Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Danish: Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, der skal implementeres af medlemslandene
English: Annex Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Danish: Bilag Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, der skal implementeres af medlemslandene
English: Concomitant Medication checklist
Danish: Kontraindiceret samtidig medicin
English: • That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Eurartesim, and in particular, those associated with a QT prolongation.
Danish: • At patienterne skal rådes til at kontakte lægen vedrørende uønskede hændelser, og at lægerne/apoteket skal indrapportere mistænkte bivirkninger ved Eurartesim og især bivirkninger forbundet med QT-forlængelse.
English: • The Physician Leaflet including the Contraindicated Conditions of Use and Contraindicated
Danish: • Lægebrochure, herunder Kontraindicerede betingelser for brug og afkrydsningsliste for
English: • The scope and use of the Contraindicated Conditions of Use and Contraindicated Concomitant Medication checklist
Danish: • Lægebrochure, herunder kontraindicerede betingelser for brug og afkrydsningsliste for kontraindiceret samtidig medicin.
English: The European Commission issued a decision on 27 March 2009.
Danish: Europa-Kommissionen traf en afgørelse den 27. marts 2009.
English: Ref. EMEA/CHMP/263995/2009
Danish: ref. EMEA/263910/2009
English: London, 7 April 2009 Doc.
Danish: London, den 7. april 2009 Dok.
English: The maximum dosage is 200 mg daily.
Danish: Maksimaldosis er 200 mg dagligt.
English: No data is available for children under 6 years of age.”
Danish: Der er ingen tilgængelige data for børn under 6 år."
English: Pimozide.
Danish: Pimozid.
English: What is Zoloft?
Danish: Hvad er Zoloft?
English: The CHMP adopted the following:
Danish: CHMP vedtog følgende:
English: Why was Zoloft reviewed?
Danish: Hvorfor blev Zoloft revurderet?
English: The CHMP also discussed this indication.
Danish: CHMP drøftede også denne indikation.
English: Zoloft contains the active substance sertraline.
Danish: Zoloft indeholder det aktive stof sertralin.
English: Dose changes should not occur at intervals of less than one week.”
Danish: Dosis bør ikke ændres med mindre end en uges mellemrum."
English: 1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Danish: 1 Artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbringelse på baggrund af divergerende nationale beslutninger i medlemsstaterne.
English: Prevention of recurrence of major depressive episodes”
Danish: Forebyggelse af tilbagevenden af svær depression."
English: Questions and answers on the referral for Zoloft Hard capsules and film coated tablets containing 25 mg, 50 mg or 100 mg sertraline Concentrate for oral solution containing 20 mg/ml sertraline
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Zoloft Hårde kapsler og filmovertrukne tabletter indeholdende 25 mg, 50 mg eller 100 mg sertralin Koncentrat til oral opløsning indeholdende 20 mg/ml sertralin
English: Neurotransmitters are chemicals that transfer chemical signals from one nerve cell to another.
Danish: Neurotransmittere er kemikalier, som overfører kemiske signaler fra en nervecelle til en anden nervecelle.
English: Zoloft is authorised in the European Union (EU) via national procedures.
Danish: Zoloft er godkendt i EU efter nationale procedurer.
English: Therapeutic Indication
Danish: Terapeutisk indikation
English: Zoloft can also be available in the EU and the EEA under other trade names: Tresleen, Serlain, Lustral, Tatig, Sertraline and Besitran.
Danish: Zoloft kan også forekomme i EU og EØS under følgende andre handelsnavne: Tresleen, Serlain, Lustral, Tatig, Sertraline og Besitran.
English: Low levels of serotonin in the central nervous system may be associated with depression or anxiety.
Danish: Lave serotoninniveauer i centralnervesystemet kan være forbundet med depression eller angst.
English: Panic disorder with or without agoraphobia disorder.
Danish: Panikangst med eller uden agorafobi.
English: “Subsequent doses may be increased in case of less than desired response in 50 mg increments over a period of some weeks, as needed.
Danish: "Hvis responsen er mindre end ønsket, kan de efterfølgende doser efter behov øges med 50 mg ad gangen over en periode på nogle uger.
English: Obsessive Compulsive Disorder in adults.
Danish: Obsessiv-kompulsiv tilstand hos voksne.
English: Data from the clinical programme for the indication PTSD were submitted and the results showed that only two of the four studies demonstrated efficacy.
Danish: Der blev indsendt data fra det kliniske program for indikationen PTSD, og resultaterne viste, at kun to af de fire undersøgelser påviste en effekt.
English: The review was carried out under an ‘Article 30' referral1.
Danish: Vurderingen blev gennemført inden for rammerne af en indbringelsesprocedure i henhold til artikel 301.
English: The CHMP discussed the results of the clinical programme that showed a significant improvement in reducing panic attacks.
Danish: CHMP drøftede resultaterne af det kliniske program, der viste en signifikant forbedring med hensyn til at mindske antallet af panikanfald.
English: The European Medicines Agency (EMEA) has completed a review of Zoloft.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har foretaget en vurdering af Zoloft.
English: Post-traumatic Stress Disorder:.
Danish: Posttraumatisk belastningsreaktion.
English: On 18 October 2007, the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Zoloft in the EU and the EEA.
Danish: Den 18. oktober 2007 henviste Europa-Kommissionen sagen til Udvalget for Humanmedicinske Lægemidler med henblik på harmonisering af markedsføringstilladelserne for Zoloft i EU og EØS.
English: Sertraline is a selective serotonin re-uptake inhibitor (SSRI), It works by preventing the neurotransmitter serotonin from being taken back up into nerve cells in the brain and spinal cord.
Danish: Sertralin er en selektiv serotoningenoptagelseshæmmer (SSRI), som virker ved at forhindre neurotransmitteren serotonin i at blive genoptaget i nerveceller i hjernen og rygmarven.
English: Regarding the dosing of paediatric patients with OCD, the CHMP requested the insertion of the following wording in this section:
Danish: Vedrørende dosering til pædiatriske patienter med OCD krævede CHMP, at følgende formulering blev indsat i dette punkt:
English: Prevention of relapse and recurrence was proposed during the assessment by the CHMP.
Danish: Der blev stillet forslag om tilbagefaldsforebyggelse under CHMP's vurdering.
English: The CHMP considered the wordings proposed for this section to be acceptable.
Danish: CHMP vurderede, at de foreslåede formuleringer under dette punkt var acceptable.
English: Zoloft can be used in adults to treat depression and prevent recurrence of depression, social anxiety disorder, post traumatic stress disorder (PTSD), panic disorder; and to treat obsessive compulsive disorder (OCD) in adults and children and adolescents, aged 6-17 years old.
Danish: Zoloft kan anvendes til at behandle depression hos voksne og forhindre tilbagevenden af depression, socialangst, posttraumatisk belastningsreaktion (PTSD), panikangst og til at behandle obsessivkompulsiv tilstand (OCD) hos voksne og børn og unge i alderen 6-17 år.
English: The clinical programme for the indication OCD was submitted and sertraline demonstrated a modest short-term effect and no safety concerns.
Danish: Det kliniske program for indikationen OCD blev indsendt, og der blev påvist en moderat kortsigtet effekt af sertralin og ingen sikkerhedsproblemer.
English: The CHMP concluded that short-term efficacy has been demonstrated, but that concerns remain over the lack of evidence with respect to relapse.
Danish: CHMP konkluderede, at den kortsigtede effekt er påvist, men at der fortsat er betænkeligheder ved manglen på dokumentation vedrørende tilbagefald.
English: The CHMP endorsed the harmonised indication: “Panic disorder with or without agoraphobia”.
Danish: CHMP godkendte den harmoniserede indikation: "Panikangst med eller uden agorafobi."
English: Considering the incidence of adverse events in PTSD, the CHMP agreed that the safety of sertraline in the treatment of PTSD is similar to that of major depressive disorder and does not present any new issues.
Danish: I betragtning af forekomsten af bivirkninger ved PTSD var CHMP enigt i, at sikkerheden ved sertralin til behandling af PTSD svarer til sikkerheden ved behandling af svær depression og ikke giver anledning til nye problemstillinger.
English: However, the generally lower body weights of children compared to those of adults should be taken into consideration when increasing the dose from 50 mg.
Danish: Ved øgning af dosis fra 50 mg bør der dog tages højde for, at børns kropsvægt generelt er lavere end voksnes.
English: Paediatric-onset OCD shares important similarities with the adult disorder but also shows important differences.
Danish: Der er væsentlige ligheder mellem OCD hos børn og voksne, men også væsentlige forskelle.
English: “Sertraline is indicated for the treatment of major depressive episodes.
Danish: "Sertralin er indiceret til behandling af svær depression.
English: Noting that major depression is considered to be a chronic or chronic intermittent condition, the CHMP considered it unnecessary to accept this separate indication.
Danish: CHMP noterede, at svær depression betragtes som en kronisk eller kronisk tilbagevendende lidelse, og vurderede, at det var unødvendigt at acceptere denne separate indikation.
English: Company responses provided on: 22 February 2008, 10 September 2008, 09 December 2008 Opinion date:
Danish: 22. februar 2008, 10. september 2008, 9. december 2008
English: The CHMP considered that patients with significant hepatic impairment are not strictly contraindicated with sertraline and that appropriate warnings are provided in the concerning section of the product information.
Danish: CHMP vurderede, at sertralin ikke er strengt kontraindiceret til patienter med signifikant nedsat leverfunktion, og at det relevante punkt i produktinformationen indeholder passende advarsler.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Zoloft in the European Union and the European Economic Area (EEA).
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) er af den opfattelse, at der er behov for at harmonisere ordinationsoplysningerne for Zoloft i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS).
English: Although the safety profile of sertraline is acceptable, the CHMP implemented the section ‘Posology and Method of Administration' of the SPC, to indicate that the need for continued treatment should be regularly evaluated.
Danish: Selv om sikkerhedsprofilen for sertralin er acceptabel, medtog CHMP punktet "Dosering og indgivelsesmåde" i produktresuméet for at angive, at behovet for fortsat behandling skal vurderes regelmæssigt.
English: The CHMP considered acceptable the evidence in support of the depression indication.
Danish: CHMP vurderede, at dokumentation til underbyggelse af indikationen depression var acceptabel.
English: The CHMP, considered the benefit/risk balance, approved the following indication: “Sertraline is indicated for the treatment of social anxiety disorder”.
Danish: CHMP vurderede benefit/risk-forholdet og godkendte følgende indikation: "Sertralin er indiceret til behandling af socialangst."
English: The CHMP endorsed the following: “Concomitant intake of pimozide is contraindicated (see section 4.5)”
Danish: CHMP godkendte følgende: "Samtidig indtagelse af pimozid er kontraindiceret (se pkt.
English: Therefore the CHMP endorsed the following indication: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults”,
Danish: CHMP godkendte derfor følgende indikation: "Sertralin er indiceret til behandling af obsessiv-kompulsiv tilstand (OCD) hos voksne."
English: Obsessive Compulsive Disorder in paediatric patients .In order to support the paediatric indication, one single study was submitted including children and adolescents aged 6-17.
Danish: Som understøttelse af den pædiatriske indikation blev der indsendt resultater af én undersøgelse af børn og unge i alderen 6-17 år.
English: The CHMP endorsed the harmonised indication: “Sertraline is indicated for the treatment of post traumatic stress disorder (PTSD)”,
Danish: CHMP godkendte den harmoniserede indikation: "Sertralin er indiceret til behandling af posttraumatisk belastningsreaktion (PTSD)."