FrancophonIA/ELRC3.0 huggingface dataset:
English: Ramtvedt et al. (2013) have reported that in a cross-over clinical study including 36 children with a diagnostic of ADHD (as per Norwegian diagnostic guidelines), who received, in sequence, 2 weeks each of methylphenidate, dexamfetamine and placebo, dexamfetamine and methylphenidate each produced a favourable response in 26 children (72%), but not always the same child.
Danish: Ramtvedt et al. (2013) har beskrevet en klinisk overkrydsningsundersøgelse med 36 børn med diagnosen ADHD (i henhold til norske diagnostiske retningslinjer), som hver blev behandlet i to uger med methylphenidat, dexamfetamin og placebo i nævnte rækkefølge.
English: • The Committee is also of the opinion that the proposed risk minimisation measures are appropriate to mitigate the risks of misuse and diversion.
Danish: • udvalget finder desuden de foreslåede risikominimeringsforanstaltninger tilstrækkelige til at afbøde risikoen for misbrug og ulovlig anvendelse.
English: However, the Committee also considered that the risk minimisation measures proposed are appropriate to mitigate the risk.
Danish: Udvalget fandt imidlertid de foreslåede risikominimeringsforanstaltninger tilstrækkelige til at afbøde denne risiko.
English: Taking into account all the available data, the Committee considered that there is sufficient evidence to conclude that non-responders to methylphenidate may benefit from dexamfetamine.
Danish: Udvalget fandt i de foreliggende data som helhed tilstrækkelig evidens til at konkludere, at personer, der ikke responderer på methylphenidat, kan have fordel af dexamfetamin.
English: It is accepted that dexamfetamine has potential for misuse, diversion and also dependence.
Danish: Det accepteres, at dexamfetamin har potentiale for misbrug og ulovlig anvendelse foruden afhængighed.
English: Indeed it is agreed that stimulants, including dexamfetamine, have potential for misuse, diversion and dependence.
Danish: Medlemsstaten fandt således, at stimulerende midler, herunder dexamfetamin, har potentiale for misbrug, ulovlig anvendelse og afhængighed.
English: Having considered the data submitted by the applicant, the CHMP considered that there is sufficient evidence to conclude that non-responders to methylphenidate may benefit from dexamfetamine.
Danish: Efter gennemgang af oplysningerne fra ansøgeren fandt udvalget tilstrækkelig evidens for, at dexamfetamin kan være til fordel for patienter, der ikke responderer på methylphenidat.
English: • Undertake a DUS to follow the use of prescribed dexamfetamine in the European Union using multiple data sources.
Danish: • at udføre en undersøgelse af lægemiddelanvendelse, der ved hjælp af en række datakilder følger anvendelsen af det dexamfetamin, der ordineres i EU.
English: The objecting Member State considered that, based on the pharmacodynamics and pharmacokinetics of dexamfetamine, the potential risk for dependence and abuse associated to this product is higher than that of other treatment options for ADHD.
Danish: Den indsigende medlemsstat fandt den potentielle risiko for afhængighed og misbrug af produktet større end af andre behandlingsmuligheder for ADHD på baggrund af dexamfetamins farmakodynamik og farmakokinetik.
English: Overall, the Committee considered that the risk minimisation measures proposed to mitigate the risk of abuse are appropriate.
Danish: Udvalget fandt, at de foreslåede risikominimeringsforanstaltninger tilsammen er tilstrækkelige til at afbøde risikoen.
English: In the current application, the use of dexamfetamine as second line treatment of ADHD is a measure introduced to mitigate this concern.
Danish: I den aktuelle ansøgning imødegås denne betænkelighed ved dexamfetamins anvendelse som andetvalgsbehandling til ADHD.
English: The Committee also noted that dexamfetamine-containing products have been available in the EU for several years without a risk management plan and therefore the introduction of a dexamfetamine product with a risk management plan is expected to represent a significant improvement for patients.
Danish: Introduktion af et dexamfetaminprodukt med en risikostyringsplan forventes derfor at være en væsentlig forbedring for patienterne.
English: • Conduct a PASS to evaluate the long-term safety profile of dexamfetamine in children with ADHD, specifically targeting key issues such as cardiovascular events, growth and psychiatric related adverse events.
Danish: • at udføre en sikkerhedsundersøgelse efter markedsføring (PASS) af dexamfetamins langsigtede sikkerhedsprofil hos børn med ADHD, navnlig med henblik på hovedproblemer såsom kardiovaskulære hændelser og bivirkninger af vækstmæssig og psykiatrisk art. I denne retrospektive undersøgelse (af nye brugere) skal dexamfetamin desuden sammenlignes med andre centralt stimulerende midler hvad angår risiko hos patientpopulationen.
English: The clinical data available, when taken together with clinical guidelines and the fact that the mechanism of action is different from that of other therapeutic options, supports the efficacy of dexamfetamine in second line treatment of ADHD.
Danish: Virkningen af dexamfetamin som andetvalgsbehandling ved ADHD støttes af de foreliggende kliniske data sammen med kliniske retningslinjer og det forhold, at virkningsmekanismen adskiller sig fra andre behandlingsmuligheder.
English: --1 Live recombinant E2 gene deleted bovine viral diarrhoea virus containing classical swine fever E2 (CP7_E2alf) 104.8 to 106.5 TCID50* * Tissue culture infectious dose 50%
Danish: --1 Levende, rekombinant E2-gendeleteret bovin viral diarré virus indeholdende klassisk svinefeber E2 (CP7_E2alf) 104,8 til 106,5 TCID*50
English: Packaging Content
Danish: Emballage Indhold
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelfor m
English: Target species
Danish: Pakningsst ørrelse
English: Date of first authorisation: 26/04/2019
Danish: Dato for første markedsføringstilladelse: 26/04/2019
English: Local reactions resolve within two to five days without treatment.
Danish: Lokale reaktioner fortager sig inden for to til fem dage uden behandling.
English: No data available.
Danish: Der er ingen tilgængelige data.
English: from the beginning of the gestational period.
Danish: Fra begyndelsen af drægtighedsperioden
English: The second dose being given at least 3 weeks before mating.
Danish: Anden dosis skal gives mindst 3 uger før løbning.
English: Transient redness or swelling (up to 4 cm) caused by the injection procedure is very common.
Danish: Forbigående rødme eller hævelse (op til 4 cm) forårsaget af injektionsproceduren er meget almindelig.
English: Each bottle is closed with a rubber stopper and an aluminium cap.
Danish: Hver flaske er lukket med gummiprop og en aluminiumshætte.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after ‘EXP'.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på den ydre emballage og flasken efter 'EXP'.
English: Avoid introduction of contamination during use.
Danish: Undgå kontaminering ved brug.
English: DATE OF AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with ReproCyc PRRS EU and administered at one injection site.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan blandes med ReproCyc PRRS EU og administreres på ét injektionssted.
English: Ensure that the lyophilisate is completely reconstituted before use.
Danish: Sørg for at lyofilisatet er fuldstændig rekonstitueret før brug.
English: ReproCyc PRRS EU (lyophilisate)
Danish: ReproCyc PRRS EU (lyofilisat)
English: Overdose (symptoms, emergency procedures, antidotes): No data available.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): Der er ingen data tilgængelige data.
English: The following corresponding presentations (doses) can be mixed:
Danish: De følgende tilsvarende doser kan blandes:
English: An elevation in the body temperature after vaccination is common which resolves spontaneously within 24 to 48 hours.
Danish: En øgning af legemstemperaturen efter vaccination er almindelig og fortager sig spontant inden for 24 til 48 timer.
English: The package leaflet of ReproCyc PRRS EU should also be consulted before the administration of the mixed product.
Danish: Indlægssedlen for ReproCyc PRRS EU bør også læses før administration af det blandede produkt.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRLværdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Adjuvant: Carbomer 2 mg.
Danish: Adjuvans: Carbomer 2 mg.
English: For pigs previously non-vaccinated against porcine parvovirus: Two intramuscular injections of one dose, 3 weeks apart.
Danish: Svin, som ikke tidligere er vaccineret mod porcin parvovirus: To intramuskulære injektioner af én dosis med 3 ugers mellemrum.
English: Re-vaccination scheme:
Danish: Re-vaccinationsplan:
English: Administer a single dose (2 ml) of the mixture intramuscularly.
Danish: Administrer en enkelt dosis (2 ml) af blandingen intramuskulært.
English: This vaccine is designed to stimulate the development of an active immune response in pigs to porcine parvovirus.
Danish: Denne vaccine er udformet til at stimulere udviklingen af et aktivt immunrespons i svin overfor porcin parvovirus.
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines, porcine parvovirus ATCvet code: QI09AA02
Danish: Farmakoterapeutisk gruppe: Immunologica til svin, inaktiverede virale vacciner, parvovirus vaccine ATCvet-kode: QI09AA02
English: Shelf life after first opening of the bottle: use within 8 hours.
Danish: Opbevaringstid efter første åbning af flasken: anvendes indenfor 8 timer.
English: Pregnancy and lactation: Can be used during pregnancy and lactation.
Danish: Drægtighed og Laktation: Kan anvendes under drægtighed og laktation.
English: Store and transport refrigerated (2 °C - 8 C).
Danish: Opbevares og transporteres nedkølet (2°C - 8°C).
English: Shelf life after first opening the immediate packaging:
Danish: Opbevaringstid efter første åbning af den indre emballage:
English: Adjuvant: Carbomer 2 mg
Danish: Adjuvans: Carbomer 2 mg
English: One dose (2 ml): Porcine Parvovirus VP2 subunit antigen Carbomer
Danish: Én dosis (2 ml): Porcin parvovirus VP2 subunit antigen Carbomer
English: Store and transport refrigerated (2 C-8 C).
Danish: Opbevares og transporteres nedkølet (2 C-8 C).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu.)
English: One intramuscular injection of one dose at least every six months is recommended in a whole herd programme (see section “Indications”).
Danish: Én intramuskulær injektion af én dosis anbefales mindst hver 6. måned, som en del af besætningens vaccinationsprogram (se afsnittet ”Indikationer”).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated , including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: The full content of one vial of ReproCyc ParvoFLEX should be used to reconstitute the lyophilisate of one vial of ReproCyc PRRS EU.
Danish: Det fulde indhold af ét hætteglas ReproCyc ParvoFLEX skal benyttes til at rekonstituere lyofilisatet af ét hætteglas ReproCyc PRRS EU.
English: Incompatibilities: Do not mix with any other veterinary medicinal product, except with ReproCyc PRRS EU.
Danish: Uforligeligheder: Må ikke blandes med lægemidler til dyr, undtaget med ReproCyc PRRS EU.
English: Sodium chloride Water for injections Potassium chloride Potassium dihydrogen phosphate Disodium phosphate anhydrous
Danish: Natriumchlorid Vand til injektionsvæsker Kaliumchlorid Kaliumdihydrogenphosphat Dinatriumphosphat, vandfri
English: Mixing with ReproCyc PRRS EU:
Danish: Blanding med ReproCyc PRRS EU:
English: 4.7 Use during pregnancy, lactation and lay
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning
English: Duration of immunity: 6 months
Danish: Indtræden af immunitet: Fra begyndelsen af drægtighedsperioden Varighed af immunitet: 6 måneder
English: Special precautions for use in animals: Not applicable.
Danish: Special forholdsregler til brug hos dyr: Ikke relevant.
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Vetmedica Inc.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Boehringer Ingelheim Vetmedica Inc.
English: Do not mix with any other veterinary medicinal product, except with ReproCyc PRRS EU.
Danish: Må ikke blandes med lægemidler til dyr, undtaget med ReproCyc PRRS EU.
English: One dose (2 ml) contains:
Danish: Én dosis (2 ml) indeholder:
English: ReproCyc ParvoFLEX hereby replaces the solvent of ReproCyc PRRS EU.
Danish: ReproCyc ParvoFLEX erstatter herved opløsningsmidlet for ReproCyc PRRS EU.
English: 20 ml bottle
Danish: 20 ml flaske
English: Shelf life of the veterinary medicinal product as packaged for sale:
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning:
English: EXP {month/year} Once broached use within 8 hours.
Danish: EXP {måneder/år} Efter anbrud: anvendes indenfor 8 timer
English: For active immunisation of gilts and sows from the age of 5 months to protect progeny against transplacental infection caused by porcine parvovirus.
Danish: Til aktiv immunisering af gylte og søer fra 5 måneders alderen for at beskytte afkom mod transplacental infektion forårsaget af porcin parvovirus.
English: 20 ml (10 doses) 100 ml (50 doses) 200 ml (100 doses) 12 x 20 ml (12 x 10 doses) 12 x 100 ml (12 x 50 doses) 12 x 200 ml (12 x 100 doses)
Danish: 20 ml (10 doser) 100 ml (50 doser) 200 ml (100 doser) 12 x 20 ml (12 x 10 doser) 12 x 100 ml (12 x 50 doser) 12 x 200 ml (12 x 100 doser)
English: Colourless to slightly brown, opalescent suspension for injection.
Danish: Farveløs til let brun, opaliserende suspension til injektion.
English: Shelf life after mixing with ReproCyc PRRS EU:
Danish: Opbevaringstid efter blanding med ReproCyc PRRS EU:
English: 100 ml, 200 ml bottle
Danish: 100 ml, 200 ml flaske
English: 6.6 Special precautions for the disposal of unused medicinal product or waste materials derived from the use of such products
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: Colourless to slightly brown, opalescent suspension.
Danish: Farveløs til let brun, opaliserende suspension.
English: Carton of 20 ml, 100 ml, 200 ml bottles
Danish: Kartonæske med 20 ml, 100 ml, 200 ml flasker
English: Name and address of the manufacturers responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Porcine Parvovirus VP2 subunit antigen: ≥ 1.0 RP* * Relative Potency (ELISA) Carbomer 2 mg.
Danish: Porcin parvovirus VP2 subunit antigen ≥ 1.0 RP* * Relativ styrke (ELISA) Carbomer 2 mg.
English: ReproCyc ParvoFLEX suspension for injection
Danish: ReproCyc ParvoFLEX injektionsvæske, suspension
English: Porcine Parvovirus strain 27a VP2 subunit antigen ≥ 1.0 RP* * Relative Potency (ELISA)
Danish: Porcin parvovirusstamme 27a VP2 subunit antigen ≥ 1.0 RP* *Relativ styrke (ELISA)
English: 100 ml (50 doses) 200 ml (100 doses)
Danish: 100 ml (50 doser) 200 ml (100 doser)
English: ReproCyc ParvoFLEX suspension for injection for pigs
Danish: ReproCyc ParvoFLEX injektionsvæske, suspension til svin
English: 100 doses (200 ml)
Danish: 100 doser (200 ml)
English: Porcine Parvovirus strain 27a VP2 subunit antigen: ≥ 1.0 RP* * Relative potency (ELISA).
Danish: Porcin parvovirusstamme 27a VP2 subunit antigen ≥ 1.0 RP* *Relativ styrke (ELISA).
English: Primary vaccination scheme:
Danish: Basis vaccination:
English: PACKAGE LEAFLET: ReproCyc ParvoFLEX suspension for injection for pigs
Danish: INDLÆGSSEDDEL: ReproCyc ParvoFLEX injektionsvæske, suspension til svin
English: High density polyethylene bottles containing 20 ml (10 doses), 100 ml (50 doses) and 200 ml (100 doses).
Danish: Højdensitet polyethylen flasker indeholdende 20 ml (10 doser), 100 ml (50 doser) og 200 ml (100 doser).
English: 1 bottle of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses).
Danish: 1 flaske á 20 ml (10 doser), 100 ml (50 doser) eller 200 ml (100 doser).
English: 12 bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses).
Danish: 12 flasker á 20 ml (10 doser), 100 ml (50 doser) eller 200 ml (100 doser).
English: Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Boehringer Ingelheim Vetmedica GmbH
English: To be supplied on veterinary prescription.
Danish: Kræver recept.
English: Overall summary of the scientific evaluation of Fanaptum
Danish: Samlet resumé af den videnskabelige vurdering af Fanaptum
English: However, no correction for multiplicity was performed when evaluating individual doses.
Danish: Der blev imidlertid ikke korrigeret for multiplicitet ved evaluering af de enkelte doser.
English: Grounds for refusal
Danish: Begrundelser for afslaget
English: Very little detailed information is available from the post-marketing setting.
Danish: Der foreligger meget få detaljerede oplysninger om erfaringer efter markedsføring.
English: There were 33 deaths of which 3 patients died during sleep, 6 were sudden deaths, and 6 cases were of cardiac origin.
Danish: Der var 33 dødsfald, hvoraf de 3 patienter døde, mens de sov, 6 dødsfald skete pludseligt, og 6 tilfælde var hjerterelaterede.
English: It is not considered that the risk minimization measures proposed would appropriately address the risk identified in this specific case.
Danish: Det vurderes ikke, at de foreslåede risikominimerende foranstaltninger i tilstrækkelig grad imødegår den risiko, der er identificeret i den konkrete sag.
English: As 4423 patients were exposed to Iloperidone, this accounts for 0.14% of all treated patients.
Danish: Med 4 423 patienter eksponeret for iloperidon svarer dette til 0,14 % af alle behandlede patienter.
English: Several approaches to various data sets support the notion that full efficacy of Fanaptum is not achieved before Week 3.
Danish: Flere forskellige tilgange til forskellige datasæt understøtter, at der ikke opnås fuld virkning med Fanaptum før uge 3.
English: This means that, from a precautionary approach, patients could not safely be concomitantly treated with a large number of other medicines.
Danish: Det betyder ud fra et sikkerhedsmæssigt synspunkt, at patienter ikke sikkert kan behandles samtidigt med et stort antal andre lægemidler.
English: In addition, there is at least one literature case report of arrhythmia.
Danish: Derudover er der i litteraturen mindst ét tilfælde af arytmi.
English: Thus, Study 3101 was the only positive short-term study exclusively conducted in schizophrenia patients.
Danish: Undersøgelse 3101 var således den eneste positive kortvarige undersøgelse, der blev udført udelukkende hos skizofrene patienter.
English: Therefore, the CHMP has recommended the refusal of the granting of the marketing authorisation for Fanaptum.
Danish: CHMP har derfor anbefalet afslag på ansøgningen om udstedelse af markedsføringstilladelse for Fanaptum.
English: In conclusion, there was no robust support for statements concerning dose-response relationship below 24 mg/day (the dose used in study 3101).
Danish: Derfor var der ikke noget solidt grundlag for at fremsætte erklæringer vedrørende dosis-respons-forhold under 24 mg/dag (den dosis, der blev anvendt i undersøgelse 3101).
English: The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the SmPC.
Danish: Kvaliteten af dette produkt vurderes at være acceptabel, når det bruges efter anvisningerne i produktresuméet.
English: Unfortunately, the CYP2D6 genotype was not known in the patients that died during the clinical studies or post-marketing.
Danish: Desværre kendte man ikke CYP2D6-genotypen hos de patienter, der døde under de kliniske undersøgelser eller efter markedsføring.
English: The efficacy of daily doses lower than 24 mg was insufficiently characterised.
Danish: Virkningen af daglige doser under 24 mg var ikke tilstrækkeligt karakteriseret.
English: However, post-hoc analyses presented in support of this argument were based on patients completing at least 2 weeks of treatment, which is a different population from that originally assigned to treatment.
Danish: Post-hoc-analyser, der blev fremlagt til støtte for dette argument, var imidlertid baseret på patienter, der havde gennemført minimum to ugers behandling, dvs. en anden population end den, der oprindeligt blev valgt til behandling.
English: In addition, whether the correct implementation of the complete set of measures would be feasible in all clinical settings is questionable due to practical reasons (for example the availability of suitably trained cardiologists), as also mentioned by the Experts in the ad-hoc meeting.
Danish: Hvorvidt det er muligt at implementere det fulde sæt foranstaltninger korrekt i alle kliniske situationer, er desuden tvivlsomt af praktiske grunde (f.eks. tilgængeligheden af tilstrækkeligt uddannede kardiologer), som også eksperterne bemærkede på ad hoc-mødet.
English: Similarly, at Week 2 it was 4.2 for ziprasidone i.e. almost full efficacy, whereas the difference was still only 2.8 for Fanaptum.
Danish: På samme måde var forskellen for ziprasidon 4,2 i uge 2, dvs. næsten fuld virkning, mens forskellen stadig kun var 2,8 for Fanaptum.
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Danish: De fysisk-kemiske og biologiske aspekter, hvad angår en ensartet klinisk effekt af lægemidlet, er tilstrækkeligt undersøgt og kontrolleret.
English: Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Danish: Videnskabelige konklusioner og begrundelser for afslag fremlagt af Det Europæiske Lægemiddelagentur
English: The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Danish: CHMP er af den opfattelse, at sikkerheden ved ovennævnte lægemiddel ikke er dokumenteret på passende og tilstrækkelig vis som fastsat i artikel 12 i forordning (EF) nr. 726/2004.