FrancophonIA/ELRC3.0 huggingface dataset:
English: Steady-state was reached after 4 days to 5 days of once-daily dosing with canagliflozin 100 mg to 300 mg. Canagliflozin does not exhibit time-dependent pharmacokinetics, and accumulated in plasma up to 36% following multiple doses of 100 mg and 300 mg.
Danish: Den tilsyneladende terminalhalveringstid (t1/2) (udtrykt som middelværdi ± standardafvigelse) var 10,6 ± 2,13 timer og 13,1 ± 3,28 timer for doserne på henholdsvis 100 mg og 300 mg. Steady state blev nået efter 4 dage til 5 dage med en daglig administration af canagliflozin 100 mg til 300 mg. Canagliflozin udviser ikke tidsafhængig farmakokinetik, og op til 36 % akkumuleres i plasma efter gentagne doser på 100 mg eller 300 mg.
English: Canagliflozin is not recommended for use in patients receiving loop diuretics (see section 4.5) or who are volume depleted, e.g., due to acute illness (such as gastrointestinal illness).
Danish: 4.5), eller som er volumendepleterede f.eks. på grund af akut sygdom (såsom mave-tarm-sygdom).
English: If renal function falls persistently below eGFR 45 mL/min/1.73 m2 or CrCl < 45 mL/min,
Danish: Hvis nyrefunktionen falder til eGFR < 45 ml/min/1,73 m2 eller CrCl < 45 ml/min, bør behandlingen med canagliflozin seponeres.
English: Statistically significant (p<0.001) changes from baseline HbA1c relative to placebo of -0.57% and -0.70% were observed for 100 mg and 300 mg, respectively (see sections 4.2 and 4.8).
Danish: HbA1c i forhold til placebo på -0,57 % og -0,70 % for henholdsvis 100 mg og 300 mg (se pkt.
English: If you take more of this medicine than you should, talk to a doctor straight away.
Danish: I disse tilfælde skal du straks søge læge.
English: Each tablet contains100 mg or 300 mg of canagliflozin.
Danish: En tablet indeholder canagliflozinhemihydrat svarende til 100 mg eller 300 mg canagliflozin.
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2, the incidences were 4.8% on canagliflozin 100 mg and 8.1% on canagliflozin 300 mg compared to 2.6% in the control group.
Danish: For patienter med eGFR 30 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline var incidensen 4,8 % med canagliflozin
English: -2.4b
Danish: 4.2 og
English: EU/1/13/884/001 (10 tablets) EU/1/13/884/002 (30 tablets) EU/1/13/884/003 (90 tablets) EU/1/13/884/004 (100 tablets)
Danish: EU/1/13/884/004 (100 tabletter)
English: Haematocrit increase was observed with canagliflozin treatment (see section 4.8); therefore, caution in patients with already elevated haematocrit is warranted.
Danish: 4.8), og forsigtighed tilrådes hos patienter, der allerede har forhøjet hæmatokrit.
English: Canagliflozin increased the incidence of testicular Leydig cell tumours in male rats at all doses tested (10, 30, and 100 mg/kg); the lowest dose of 10 mg/kg is approximately 1.5 times the clinical dose of 300 mg based on AUC exposure.
Danish: Når eksponering måles som AUC, gav den højeste dosis på 100 mg/kg op til 14 gange eksponeringen ved den kliniske dosis på 300 mg. Canagliflozin øgede incidensen af Leydigcelletumorer i testiklerne hos hanrotter ved alle de undersøgte doser (10, 30 og 100 mg/kg.
English: Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and
Danish: Elimination Efter administration af en enkelt oral dosis [14C-mærket] canagliflozin til raske forsøgspersoner blev
English: Patients (%) achieving HbA1c < 7% 45.5b
Danish: Patienter (%) der opnåede HbA1c
English: Difference from sitagliptin (adjusted mean) (95% CI)
Danish: glimepiride (justeret gennemsnitstal) [95% CI]
English: % change from baseline (adjusted mean)
Danish: Baseline (gennemsnit) Ændring fra baseline (justeret gennemsnitsændring) Forskel ift.
English: Bone fracturee
Danish: Knoglebrud e
English: Adverse reaction
Danish: Nyrefunktionen
English: • St. John's wort (an herbal medicine to treat depression)
Danish: • perikon (naturlægemiddel mod depression)
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking this medicine.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis et af disse punkter passer på dig (eller hvis du har mistanke om det), før du tager dette lægemiddel.
English: < 60 mL/min/1.73 m2, canagliflozin provided clinically meaningful reduction in HbA1c compared to placebo, with -0.47% for canagliflozin 100 mg and -0.52% for canagliflozin 300 mg.
Danish: Patienter med eGFR 45 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 I en poolet analyse af patienter (N = 721) med eGFR 45 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline, udvirkede canagliflozin en klinisk relevant reduktion i HbA1c sammenlignet med placebo på -0,47 % for canagliflozin 100 mg og -0,52 % for canagliflozin 300 mg.
English: Change from baseline (adjusted mean) Difference from placebo (adjusted mean) (97.5% CI)
Danish: placebo (justeret gennemsnitstal) [95% KI] (97,5% CI)
English: c Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Danish: c Udslæt omfatter termerne erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, kløende udslæt, pustuløst udslæt og vesikuløst udslæt.
English: In patients where DKA is suspected or diagnosed, treatment with canagliflozin should be discontinued immediately.
Danish: Canagliflozin skal straks seponeres hos patienter med formodet eller verificeret DKA.
English: Elimination
Danish: Opbevaring
English: Gastrointestinal disorders common
Danish: Mave-tarm-kanalen Almindelig
English: (Invented) Name
Danish: (Særnavn) Navn
English: Member State EU/EEA Applicant
Danish: Medlemsstat EU/EEA
English: Furthermore BHA is an approved and widely used food additive (E 320) in the European Union.
Danish: BHA er desuden godkendt og bredt anvendt som et tilsætningsstof (E 320) i EU.
English: Because no agreement was reached at Day 60, the procedure was referred to the CHMP.
Danish: Da der ikke var opnået enighed på dag 60, blev sagen henvist til CHMP.
English: GROUNDS FOR POSITIVE OPINION
Danish: BEGRUNDELSER FOR POSITIV UDTALELSE
English: The legal basis under which the application was submitted is Art 10(1) in combination with Art. 28(3) of Directive 2001/83/EC, as amended.
Danish: Retsgrundlaget for indgivelse af ansøgningen er artikel 10, stk. 1, samt artikel 28, stk. 3, i direktiv 2001/83/EF med senere ændringer.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR POSITIV UDTALELSE FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: The Applicant defended the objection that not all possible salts had been considered.
Danish: Ansøgeren forsvarede indsigelsen om, at ikke alle brugbare salte var blevet overvejet.
English: The manufacturing process has been successfully validated with three batches.
Danish: Fremstillingsprocessen er blevet valideret med et godt resultat med tre batcher.
English: Three out of the nineteen adverse events did not require any medical intervention.
Danish: Tre ud af de 19 bivirkninger krævede ikke nogen medicinske indgreb.
English: - Quality issues
Danish: - Kvalitetsspørgsmål
English: - in the view of the CHMP, do not differ with regard to safety relevant properties.
Danish: - er efter CHMP's mening ikke anderledes med hensyn til sikkerhedsrelevante egenskaber.
English: Batch analysis results have demonstrated consistent quality.
Danish: Batchanalyseresultaterne har vist en konsistent kvalitet.
English: - Clinical issues
Danish: - Kliniske spørgsmål
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CLOPIDOGREL ORION
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF CLOPIDOGREL ORION
English: Hence a premix development using a suitable vehicle was considered.
Danish: Derfor overvejede man at udvikle et premix ved hjælp af et passende medium.
English: It was argued by the objecting CHMP members that according to the Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product (EMEA/CHMP/QWP/396951/2006) and the Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products (CPMP/CVMP/QWP/115/95), the use of antioxidants should be avoided whenever possible.
Danish: Det blev fremført af de medlemmer af CHMP, der gjorde indsigelse, at brugen af antioxidanter i henhold til vejledningen vedrørende konstituenser i sagsmappen for ansøgning om markedsføringstilladelse til et lægemiddel (EMEA/CHMP/QWP/396951/2006) og "Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products" (vejledning om tilsætning af antioxidanter og antimikrobielle konserveringsmidler til lægemidler) (CPMP/CVMP/QWP/115/95) så vidt muligt bør undgås.
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Danish: CHMP vurderede dossieret og de tilgængelige data, herunder spørgsmålene rejst af den berørte medlemsstat, der havde gjort indsigelse.
English: It was argued that at that time, the potential to develop a salt with suitable pharmaceutical and pharmacological properties, and free from any FTO (freedom-to-operate) issues later, was thoroughly literature researched.
Danish: Det blev fremført, at muligheden for at udvikle et salt med passende farmaceutiske og farmakologiske egenskaber og fri for alle FTO-spørgsmål (freedom to operate) senere blev grundigt undersøgt i litteraturen på det aktuelle tidspunkt.
English: This was not considered to be acceptable by the objecting Concerned Member State (CMS) as there are stable salts available, and the use of the clopidogrel base was considered to result in an unnecessary exposure of patients to an antioxidant.
Danish: Dette blev ikke anset for at være acceptabelt af den berørte medlemsstat, der havde gjort indsigelse, da der findes stabile salte, og brugen af clopidogrelbasen blev anset for at resultere i en unødvendig eksponering af patienterne for en antioxidant.
English: Out of 19 adverse events observed, 14 were for the reference product and 5 were for the test product.
Danish: Af de 19 observerede bivirkninger vedrørte 14 referencelægemidlet og 5 testlægemidlet.
English: Furthermore the objecting CHMP members pointed out that in both guidelines, it is also stated that antioxidants should not be used to disguise poorly formulated products.
Danish: De medlemmer af CHMP, der gjorde indsigelse, påpegede desuden, at det også fremgik af begge vejledninger, at antioxidanter ikke bør anvendes til at sløre dårligt formulerede lægemidler.
English: The Applicant addressed the long-term safety of BHA at the oral explanation before the CHMP on 17 February 2010, by making reference to the Acceptable Daily Intake (ADI), an estimate of the amount of BHA that can be ingested on a daily basis over a lifetime without appreciable risk to health.
Danish: Ansøgeren behandlede den langsigtede sikkerhed ved BHA i en mundtlig redegørelse for CHMP den 17. februar 2010 ved at henvise til den acceptable daglige indtagelse (ADI), et skøn over den mængde BHA, der kan indtages dagligt gennem et helt liv uden mærkbar sundhedsrisiko.
English: The issue was referred to the CMD(h) and an assessment was carried out by the Reference Member State (RMS).
Danish: Sagen blev henvist til den humanmedicinske koordineringsgruppe CMD(h), og en vurdering blev gennemført af referencemedlemsstaten.
English: In order to circumvene the challenges of using the clopidogrel base, it was essential to convert it into a granular and free flowable material.
Danish: For at omgå udfordringerne i forbindelse med anvendelse af clopidogrelbasen var det vigtigt at omdanne den til et fritflydende, kornet materiale.
English: The drug substance and the drug product manufacturer have been shown to be capable of producing a, stable product essentially similar in efficacy and safety to the reference product.
Danish: Lægemiddelstoffet og lægemiddelproducenten har vist, at de er i stand til at frembringe et stabilt lægemiddel, der i virkning og sikkerhed i det væsentlige svarer til referencelægemidlet.
English: The chosen clopidogrel base necessitated the use of an antioxidant which was not considered to be optimal.
Danish: Den valgte clopidogrelbase nødvendiggjorde brugen af en antioxidant, hvilket ikke blev anset for at være optimalt.
English: The adenylate cyclase-coupled ADP receptor P2Y12 is the main target of clopidogrel and leads to inhibition of platelet activation, aggregation, and Gp IIb/IIIa receptor activation.
Danish: Den adenylatcyklasebundne ADP-receptor P2Y12 er det vigtigste mål for clopidogrel og fører til en hæmning af blodpladeaktiveringen, aggregeringen og Gp IIb/IIIa-receptoraktiveringen.
English: In addition, the CHMP was also concerned that it had not been demonstrated that the proposed production and quality control methods could guarantee that a major deficiency in the quality of the product would not occur.
Danish: CHMP var derudover også betænkeligt ved, at det ikke var blevet dokumenteret, at de foreslåede produktions- og kvalitetskontrolmetoder kunne sikre, at der ikke ville opstå en større kvalitetsmangel ved lægemidlet.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: In the bioequivalence study, a total of 19 adverse events were reported by 13 subjects.
Danish: I bioækvivalensundersøgelsen indberettede 13 forsøgspersoner i alt 19 bivirkninger.
English: When clopidogrel bisulfate (as in Reference product) and clopidogrel base (as in Test product) were administered as a single dose to healthy volunteers in this study, the drug products were well tolerated with no serious adverse events for either, and no relevant difference in the safety profiles of the test and reference formulation was observed with regard to the number and pattern of adverse events.
Danish: Når clopidogrelbisulfat (som i referencelægemidlet) og clopidogrelbasen (som i testlægemidlet) blev givet som en enkelt dosis til raske frivillige i denne undersøgelse, var lægemiddelstofferne godt tolereret, ingen af dem gav anledning til alvorlige bivirkninger, og der blev ikke observeret nogen relevant forskel i sikkerhedsprofilerne for testformuleringen og referenceformuleringen med hensyn til antallet af bivirkninger og bivirkningsmønstrene.
English: The Applicant explained that the amount of BHA from clopidogrel tablets was no more than 0.75% of its ADI, which was argued to be a negligible.
Danish: Ansøgeren forklarede, at mængden af BHA fra clopidogreltabletter kun var 0,75 % af ADI, hvilket blev anset for at være ubetydeligt.
English: The Applicant also claimed that the test product when compared with the reference product Plavix, met the bioequivalence criteria with respect to the rate and extent of absorption of clopidogrel.
Danish: Ansøgeren hævdede også, at testlægemidlet, når det blev sammenlignet med referencelægemidlet Plavix, opfyldte bioækvivalenskriterierne med hensyn til absorptionshastighed og -omfang for clopidogrel.
English: In contrast to the reference product that contains the hydrogen sulphate salt, the generic product contains a clopidogrel base.
Danish: I modsætning til referencelægemidlet, som indeholder hydrogensulfatsalt, indeholder det generiske lægemiddel en clopidogrelbase.
English: Although the clopidogrel free base posed the challenges of converting an unstable, gummy and sticky nature into a granular, free flowing and stable material for use in formulations, the Applicant chose the clopidogrel free base as the suitable candidate for product development.
Danish: Selv om den frie clopidogrelbase indebar udfordringer med at omdanne et ustabilt, gummiagtigt og klæbende materiale til et fritflydende, kornet og stabilt materiale til brug i formuleringer, valgte ansøgeren den frie clopidogrelbase som en egnet kandidat til lægemiddeludvikling.
English: It is also argued that in view of the above, the selection of the clopidogrel base and the development of the clopidogrel premix had been justified for its use in generic formulation.
Danish: Det hævdes ligeledes på baggrund af ovenstående, at valget af clopidogrelbasen og udviklingen af clopidogrelpremix er blevet begrundet til brug i den generiske formulering.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gældende Produktresume, etikettering og indlægsseddel, er de endelige versioner, som opnået ved Koordinationsgruppeprocedure.
English: However in view of the fact that no major concerns were found in relation to quality of the product and that the use of antioxidant did not pose a safety concern, the CHMP accepted the choice of the clopidogrel base.
Danish: Da kvaliteten af lægemidlet imidlertid ikke gav anledning til nogen større betænkeligheder, og brugen af antioxidanten ikke gav anledning til sikkerhedsmæssige betænkeligheder, accepterede CHMP valget af clopidogrelbasen.
English: The product developed with clopidogrel premix was found to be non-hygroscopic.
Danish: Det lægemiddel, der blev udviklet med clopidogrelpremix, blev anset for at være ikkehygroskopisk.
English: Therefore the chosen antioxidant BHA and the concentration in which it is used, was considered to be acceptable by the CHMP, from a safety point of view.
Danish: Derfor anså CHMP den valgte antioxidant BHA og den koncentration, i hvilken den anvendes, for at være acceptabel ud fra et sikkerhedsmæssigt synspunkt.
English: The Applicant attended the CHMP meeting for an oral explanation on 17 February 2010 to present their position with regard to the choice of clopidogrel base as the active substance compared to the more stable clopidogrel salts, and also to discuss the safety of the long-term use of BHA.
Danish: Ansøgeren fremsatte en mundtlig redegørelse på CHMP's møde den 17. februar 2010, hvor udvalget fremlagde sin holdning til valget af clopidogrelbasen som det aktive stof sammenlignet med de mere stabile clopidogrelsalte og drøftede sikkerheden ved en langvarig brug af BHA.
English: Since the nature of the base made it unsuitable to incorporate appropriate in-process quality checks for the clopidogrel base, the Applicant has attempted to control the quality of the base produced by ensuring the quality of the intermediate.
Danish: Da basens art gjorde den uegnet til at indarbejde passende kvalitetskontroller af clopidogrelbasen under processen, har ansøgeren forsøgt at kontrollere kvaliteten af den producerede base ved at sikre kvaliteten af mellemproduktet.
English: Overall, it is claimed by the Applicant that their clopidogrel tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product.
Danish: Generelt hævder ansøgeren, at dennes clopidogreltabletter 75 mg er af tilstrækkelig kvalitet og har et tilstrækkeligt benefit/risk-forhold og er sammenlignelige med referencelægemidlet.
English: Taking into consideration the literature survey, the taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts and free base of clopidogrel were considered.
Danish: På baggrund af litteraturundersøgelsen blev taurocholat, hydrochlorid-, hydrobromid- og hydrogensulfatsalte og den frie clopidogrelbase overvejet.
English: Clopidogrel is a non-competitive inhibitor of adenosine diphosphate (ADP) at the platelet receptors.
Danish: Clopidogrel er en non-kompetitiv hæmmer af adenosindiphosphat (ADP) på blodpladereceptorer.
English: The Clopidogrel Orion 75 mg Film coated Tablets:
Danish: Clopidogrel Orion 75 mg filmovertrukne tabletter:
English: The use of the unstable clopidogrel base as active substance necessitated the use of the antioxidant butylated hydroxyl anisol (BHA) for stabilisation.
Danish: Anvendelsen af den ustabile clopidogrelbase som aktivt stof nødvendiggjorde anvendelsen af antioxidanten butyleret hydroxylanisol (BHA) til stabilisering.
English: The premix approach was thought to help in the flow property of clopidogrel base.
Danish: Premix-fremgangsmåden blev anset for at bidrage til clopidogrelbasens flowegenskab.
English: The CHMP agreed that the Applicant's choice of the clopidogrel base and consequently the use of BHA had been sufficiently explained.
Danish: CHMP var enig i, at ansøgerens valg af clopidogrelbasen og dermed brugen af BHA var blevet tilstrækkeligt forklaret.
English: Based on the information presented, taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts of clopidogrel were found to be unsuitable for product development for various reasons.
Danish: På baggrund af de fremlagte undersøgelser blev taurocholat, hydrochlorid-, hydrobromid- og hydrogensulfatsalte af clopidogrel af forskellige årsager anset for at være uegnede til lægemiddeludvikling.
English: Czech Republic
Danish: Den Tjekkiske Republik
English: The Applicant explained that to make it feasible for better handling, it was decided to add the excipient BHA, which in turn resulted in a stable clopidogrel premix.
Danish: Ansøgeren forklarede, at det for at gøre det nemmere at håndtere clopidogrelbasen blev besluttet at tilsætte hjælpestoffet BHA, som resulterede i et stabilt clopidogrelpremix.
English: Clopidogrel is known to hydrolyse and to form a hydrolytic impurity i.e an acetic acid impurity, which is a major degradant.
Danish: Clopidogrel er kendt for at hydrolysere og danne en hydrolytisk urenhed, dvs. en eddikesyreurenhed, som er en vigtig nedbryder.
English: Clopidogrel is indicated for the prevention of atherothrombotic events in patients suffering from myocardial infarction or acute coronary syndrome.
Danish: Clopidogrel er indiceret til patienter med myokardieinfarkt eller akut koronarsyndrom til forebyggelse af aterotrombotiske hændelser.
English: As the clopidogrel base corresponds to an unstable, viscous mass, the drug substance is stabilized by means of a premix, which contains the antioxidant butylated hydroxy anisol (BHA).
Danish: Da clopidogrelbasen er en ustabil, viskøs masse, stabiliseres lægemiddelstoffet ved hjælp af et premix, der indeholder antioxidanten butyleret hydroxyanisol (BHA).
English: Slovak Republic
Danish: Den Slovakiske Republik
English: The product is formulated as immediate release tablets containing 75 mg clopidogrel.
Danish: Lægemidlet findes som tabletter med umiddelbar frigivelse indeholdende 75 mg clopidogrel.
English: The reference medicinal product for this generic application is Plavix (Clopidogrel Hydrogen sulphate) 75 mg film-coated tablets.
Danish: Referencelægemidlet for dette generiske lægemiddel er Plavix (clopidogrelhydrogensulfat) 75 mg filmovertrukne tabletter.
English: From the data provided the Applicant claimed that clopidogrel tablets 75 mg are stable when compared to Plavix 75 mg (Clopidogrel Bisulphate Tablets 75 mg).
Danish: På grundlag af de fremlagte data hævdede ansøgeren, at clopidogreltabletter 75 mg er stabile sammenlignet med Plavix 75 mg (clopidogrelbisulfattablet 75 mg).
English: The acetic acid impurity (a major degradant) was found to be controlled in the Applicant's clopidogrel Tablets 75 mg as compared to Plavix 75 mg (Clopidogrel Bisulphate Tablet 75 mg).
Danish: Eddikesyreurenheden (en vigtig nedbryder) blev anset for at være kontrolleret i ansøgerens clopidogreltabletter 75 mg sammenlignet med Plavix 75 mg (clopidogrelbisulfattablet 75 mg).
English: The overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base, and the proposed specifications for the clopidogrel base are considered to be acceptable by the CHMP.
Danish: Den overordnede kontrolstrategi for at sikre en passende og reproducerbar lægemiddelkvalitet er blevet dokumenteret med hensyn til håndtering af clopidogrelbasens viskøse masse, og CHMP anser de foreslåede specifikationer for clopidogrelbasen for at være acceptable.