natgillin/translations-raw huggingface dataset:
Amning er kontraindiceret under administration af Zejula og i 1 måned efter den sidste dosis (se pkt.
Breast-feeding is contraindicated during administration of Zejula and for 1 month after receiving the last dose (see section 4.3).
Hvis en patient udvikler svær vedvarende hæmatologisk toksicitet, der ikke forsvinder i løbet af 28 dages afbrydelse, skal Zejula seponeres.
If a patient develops severe persistent haematologic toxicity that does not resolve within 28 days following interruption, Zejula should be discontinued.
Anden forekomst:
Second occurrence:
Søvnløshed, angst, depression
Insomnia, anxiety, depression
Niraparib hæmmer MATE1 og -2 med en IC50 på hhv. 0,18 µm og ≤ 0,14 µm.
Niraparib is an inhibitor of MATE1 and -2 with IC50 of 0.18 µM and ≤ 0.14 µM, respectively.
Den mediane varighed af trombocytopeni-hændelser af alle grader var 23 dage, og den mediane varighed af trombocytopeni-hændelser af grad 3/4 var 10 dage.
The median duration of thrombocytopenia events of any grade was 23 days, and the median duration of Grade 3/4 thrombocytopenia was 10 days.
I HRDneg-gruppen var hazard ratio 0,58 (95 %-KI, 0,361-0,922, p < 0,0226).
In the HRDneg group, the hazard ratio was 0.58 (95 % CI, 0.361, 0.922; p = 0.0226).
Forhøjet ASAT, forhøjet ALAT, forhøjet alkalisk fosfatase
AST increased, ALT increased, blood alkaline phosphatase increased
Pædiatrisk population Der er ikke gennemført studier til undersøgelse af farmakokinetikken af niraparib hos børn.
Paediatric population No studies have been conducted to investigate the pharmacokinetics of niraparib in paediatric patients.
Der var flere patienter i niraparib-gruppen end i placebogruppen, der fortsatte behandling i mere end 12 måneder (hhv. 54,4 % og 16,9 %).
More patients in the niraparib group continued treatment for more than 12 months than patients in the placebo group (54.4 % and 16.9 % respectively).
I den farmakokinetiske populationsanalyse af data fra kliniske studier hos patienter havde eksisterende let og moderat nedsat leverfunktion ingen indflydelse på clearance af niraparib.
In the population pharmacokinetic analysis of data from clinical studies in patients, pre-existing mild and moderate hepatic impairment did not influence the clearance of niraparib.
Hypertension skal behandles medicinsk med antihypertensiva, og Zejula-dosis skal om nødvendigt justeres (se pkt.
Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Zejula dose (see section 4.2), if necessary.
Trombocytopeni forekom hyppigere hos patienter med et trombocyttal på under 180 x 109/l ved baseline.
Thrombocytopenia occurred more commonly in patients whose baseline platelet count was less than 180 × 109/L.
Niraparib er et substrat for CYP'er (CYP1A2 og CYP3A4) Niraparib er et substrat for carboxylesteraser (CE'er) og UDP-glucuronosyltransferaser (UGT'er) in vivo.
Niraparib as a substrate of CYPs (CYP1A2 and CYP3A4) Niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs) in vivo.
Der blev ikke identificeret patienter med eksisterende svært nedsat nyrefunktion eller terminal nyresygdom i dialyse i de kliniske studier (se pkt.
No patients with pre-existing severe renal impairment or end-stage renal disease undergoing hemodialysis were identified in clinical studies (see section 4.2).
Mundtørhed, udspilet mave, slimhindebetændelse (herunder mucositis), stomatitis
Dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis
Det primære tumorsted hos de fleste patienter (> 80 %) i hver kohorte var ovarierne.
The primary tumour site in most patients (> 80 %) within each cohort was the ovary; most patients (> 84 %) had tumours with serous histology.
CTCAE*-kriterierne), hvor profylakse ikke anses for at være mulig, eller bivirkning varer ved trods behandling.
Non-haematologic CTCAE* ≥ Grade 3 treatment-related adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment
Niraparib var ikke mutagent i en bakteriel revers mutationsanalyse (Ames), men var klastogent i en in vitro-kromosomafvigelsesanalyse hos pattedyr og i en in vivo-analyse af knoglemarvsmikronukleus hos rotter.
Niraparib was not mutagenic in a bacterial reverse mutation assay (Ames) test but was clastogenic in an in vitro mammalian chromosomal aberration assay and in an in vivo rat bone marrow micronucleus assay.
Den hvide uigennemsigtige underdel er påtrykt "100 mg" med sort blæk, og den lilla overdel er påtrykt "Niraparib" med hvidt blæk.
The white opaque capsule body is printed with ‘100 mg' in black ink, and the purple capsule cap is printed with ‘Niraparib' in white ink.
Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
No dose adjustment is necessary for patients with mild to moderate renal impairment.
I HRDpos-gruppen var hazard ratio 0,38 (95 %-KI, 0,243-0,586, p < 0,0001).
In the HRDpos group, the hazard ratio was 0.38 (95 % CI, 0.243, 0.586; p < 0.0001).
• Unormale blodværdier
• Abnormal blood tests
Derfor bør der udvises forsigtighed, når niraparib kombineres med aktive stoffer, hvis metabolisering er CYP3A4-afhængig, og især stoffer, som har et smalt terapeutisk indeks (f.eks. ciclosporin, tacrolimus, alfentanil, ergotamin, pimozid, quetiapin og halofantrin).
Therefore, caution is recommended when niraparib is combined with active substances the metabolism of which is CYP3A4-dependent and, notably, those having a narrow therapeutic range (e.g. ciclosporin, tacrolimus, alfentanil, ergotamine, pimozide, quetiapine, and halofantrine).
Zejula må ikke bruges under graviditet eller til kvinder i den fødedygtige alder, som ikke vil anvende sikker prævention under behandlingen og i 1 måned efter den sidste dosis Zejula (se pkt.
Zejula should not be used during pregnancy or in women of childbearing potential not willing to use reliable contraception during therapy and for 1 month after receiving the last dose of Zejula (see section 4.6).
Derfor bør der udvises forsigtighed, når niraparib kombineres med aktive stoffer, hvis metabolisering er CYP1A2-afhængig, og navnlig stoffer, som har et smalt terapeutisk indeks (f.eks. clozapin, theophyllin og ropinirol).
Therefore, caution is recommended when niraparib is combined with active substances the metabolism of which is CYP1A2-dependent and, notably, those having a narrow therapeutic range (e.g. clozapine, theophylline, and ropinirole).
Hypokaliæmi
Hypokalemia
Hos patienter med et trombocyttal ved baseline på mindre end 180 × 109/l sås trombocytopeni af alle grader hos 76 % af patienterne og af grad 3/4 hos 45 % af patienterne.
In patients with baseline platelet count less than 180 × 109/L, thrombocytopenia of any grade and Grade 3/4 occurred in 76 % and 45 % of the patients, respectively.
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 254,5 mg lactosemonohydrat (se pkt.
Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4).
Ca. 30 % af de patienter, som fik Zejula, oplevede neutropeni af alle grader, og 20 % af patienterne oplevede neutropeni af grad 3/4.
Approximately 30 % of patients receiving Zejula experienced neutropenia of any grade, and 20 % of patients experienced Grade 3/4 neutropenia.
Efter en enkelt oral dosis niraparib på 300 mg lå niraparibs gennemsnitlige terminale halveringstid (t½) på 48-51 timer (ca. 2 dage).
Following a single oral 300-mg dose of niraparib, the mean terminal half-life (t½) of niraparib ranged from 48 to 51 hours (approximately 2 days).
Kvinder i den fødedygtige alder skal anvende sikker prævention under behandlingen og i 1 måned efter den sidste dosis Zejula.
Women of childbearing potential must use effective contraception during therapy and for 1 month after receiving the last dose of Zejula.
I det kliniske program blev neutropeni håndteret ved hjælp af laboratorieovervågning og dosisjusteringer (se pkt.
In the clinical programme, neutropenia was managed with laboratory monitoring and dose modifications (see section 4.2).
Ca. 76 % af patienterne med en lav blodpladeværdi ved baseline (< 180 × 109/l), som fik Zejula, oplevede trombocytopeni (alle grader), og 45 % af patienterne oplevede trombocytopeni af grad 3-4.
Approximately 76 % of patients with lower baseline platelets (< 180 × 109/L) who received Zejula experienced thrombocytopenia of any grade, and 45 % of the patients experienced Grade 3/4 thrombocytopenia.
Trombocytopeni, anæmi, neutropeni
Thrombocytopenia, anaemia, neutropenia
Genoptag Zejula i nedsat dosis.
• Resume Zejula at a reduced dose.
Tilbagehold Zejula i maksimalt 28 dage, og overvåg blodtallene ugentligt, indtil neutrofiltallet igen er ≥ 1.500/µl, eller hæmoglobin igen er ≥ 9 g/dl.
• Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥ 1,500/µL or haemoglobin returns to ≥ 9 g/dL.
Brug ikke dette lægemiddel, hvis emballagen er beskadiget eller brudt.
Do not use this medicine if you notice any damage or signs of tampering to the pack.
(Nir:plac) (95 %-KI*)
(Nir:plac) (95 % CI*) * CI denotes confidence interval.
Hypertension, herunder hypertensiv krise, er indberettet i forbindelse med behandling med Zejula.
Hypertension, including hypertensive crisis, has been reported with Zejula therapy.
Niraparib er ikke et substrat for MATE 1 eller 2,
Niraparib is not a substrate of MATE 1 or 2, while M1 is a substrate of both.
Seponer Zejula, hvis neutrofiltallet og/eller hæmoglobin ikke er vendt tilbage til et acceptabelt niveau i løbet af de 28 dages dosisafbrydelse, eller hvis patientens dosis allerede er nedsat til 100 mg 1 gang dagligt.
• Discontinue Zejula if neutrophils and/or haemoglobin have not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD.
Farmakokinetikken for niraparib hos patienter med svært nedsat leverfunktion er ikke undersøgt (se pkt.
The pharmacokinetics of niraparib have not been assessed in patients with severe hepatic impairment (see section 4.2).
Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer CYP-enzymer (f.eks. itraconazol, ritonavir og clarithromycin) eller inducerer CYP-enzymer (f.eks. rifampicin, carbamazepin og phenytoin).
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit (e.g. itraconazole, ritonavir, and clarithromycin) or induce CYP enzymes (e.g. rifampin, carbamazepine, and phenytoin).
Lave blodtal Zejula giver lave blodtal, f.eks. et lavt antal røde blodlegemer (blodmangel (anæmi)), hvide blodlegemer (neutropeni) eller blodplader (trombocytopeni).
Zejula lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia).
Diarré, obstipation, slimhindebetændelse (herunder mucositis), stomatitis, mundtørhed
Diarrhoea, constipation, mucosal inflammation (including mucositis), stomatitis, dry mouth
Hvis bivirkningen varer ved ud over en dosisafbrydelse på 28 dage, bør Zejula seponeres.
If adverse reactions persist beyond a 28-day dose interruption, it is recommended that Zejula be discontinued.
PFS-median (95 %-KI*)
PFS median (95% CI*)
Kvalme, obstipation, opkastning, mavesmerter, dyspepsi
Nausea, constipation, vomiting, abdominal pain, diarrhoea, dyspepsia
Reproduktionstoksicitet
Reproductive toxicology
Bekræftet diagnose på myelodysplastisk syndrom (MDS) eller akut myeloid leukæmi (AML)
Confirmed diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia
Zejula indeholder tartrazin (E 102)
Zejula contains tartrazine (E 102)
kriterierne), der varer i mere end 28 dage, mens patienten får Zejula 100 mg/dag
CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered Zejula 100 mg/day
I det kliniske program blev trombocytopeni håndteret ved hjælp af laboratorieovervågning, dosisjustering og trombocyttransfusion, hvor det var relevant (se pkt.
In the clinical programme, thrombocytopenia was managed with laboratory monitoring, dose modification and platelet transfusion where appropriate (see section 4.2).
Seponer Zejula, hvis trombocyttallet ikke er vendt tilbage til et acceptabelt niveau i løbet af de 28 dages dosisafbrydelse, eller hvis patientens dosis allerede er nedsat til 100 mg 1 gang dagligt.
• Discontinue Zejula if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD.
Ca. 60 % af de patienter, som fik Zejula, oplevede trombocytopeni af alle grader, og 34 % af patienterne oplevede trombocytopeni af grad 3/4.
Approximately 60 % of patients receiving Zejula experienced thrombocytopenia of any grade, and 34 % of patients experienced Grade 3/4 thrombocytopenia.
Tilfældene var typiske for sekundært myelodysplastisk syndrom/akut myeloid leukæmi relateret til kræftbehandling.
The cases were typical of secondary, cancer therapy-related MDS/AML.
• 56 × 1 hårde kapsler
• 56 × 1 hard capsules
Sådan skal du tage Zejula
How to take Zejula
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
STATEMENT OF ACTIVE SUBSTANCE(S)
Den mediane varighed af neutropeni af alle grader var 26 dage og 13 dage for hændelser af grad 3/4.
The median duration of neutropenia of any grade was 26 days, and 13 days for Grade 3/4 events.
• 28 × 1 hårde kapsler
• 28 × 1 hard capsules
Virkning og anvendelse Det skal du vide, før du begynder at tage Zejula Sådan skal du tage Zejula Bivirkninger
What Zejula is and what it is used for What you need to know before you take Zejula How to take Zejula
Der kræves derfor ingen dosisjustering af Zejula, når det administreres sammen med lægemidler, der hæmmer P-gp (f.eks. amiodaron, verapamil) eller BCRP (f.eks. osimertinib, velpatasvir og eltrombopag).
Therefore, no dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit P-gp (e.g. amiodarone, verapamil) or BCRP (e.g. osimertinib, velpatasvir, and eltrombopag).
Rygsmerter, artralgi, myalgi
Back pain, arthralgia, myalgia
Den mediane tid til starten af neutropeni af alle grader var 27 dage og 29 dage for hændelser af grad 3/4.
The median time to onset of neutropenia of any grade was 27 days, and 29 days for Grade 3/4 events.
• 84 × 1 hårde kapsler
• 84 × 1 hard capsules
Der var flere patienter i niraparibgruppen end i placebogruppen, der fortsatte behandling i mere end 12 måneder (hhv. 34,2 % og
More patients in the niraparib group continued treatment for more than 12 months than patients in the placebo group (34.2 % and 21.1 %, respectively).
Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer optagelsestransportørerne OAT1 (f.eks. probenecid), OAT3 (f.eks. probenecid, diclofenac) eller OCT2 (f.eks. cimetidin, quinidin).
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OAT1 (e.g. probenecid) or OAT3 (e.g. probenecid, diclofenac), or OCT2 (e.g. cimetidine, quinidine) uptake transporters.
Kapselindhold Magnesiumstearat Lactosemonohydrat
Capsule content Magnesium stearate
De systemiske eksponeringer for niraparib (Cmax og AUC) steg proportionalt med dosis, når niraparibdosis blev øget fra 30 mg til 400 mg. Niraparibs absolutte biotilgængelighed er ca. 73 %, hvilket peger på en minimal first-pass effekt.
The systemic exposures (Cmax and AUC) to niraparib increased in a dose-proportional manner when the dose of niraparib increased from 30 mg to 400 mg.
Den mediane tid til starten af anæmi af alle grader var 42 dage og 85 dage for hændelser af grad 3/4.
The median time to onset of anaemia of any grade was 42 days, and 85 days for Grade 3/4 events.
Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer optagelsestransportørerne OATP1B1 eller 1B3 (f.eks. gemfibrozil, ritonavir) eller OCT1 (f.eks. dolutegravir).
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OATP1B1 or 1B3 (e.g. gemfibrozil, ritonavir), or OCT1 (e.g. dolutegravir) uptake transporters.
Den mediane varighed af anæmi af alle grader var 63 dage og 8 dage for hændelser af grad 3/4.
The median duration of anaemia of any grade was 63 days, and 8 days for Grade 3/4 events.
Kapslerne skal synkes hele sammen med vand.
Swallow the capsules whole, with some water.
Niraparib metaboliseres primært af carboxylesteraser (CE'er) og danner en væsentlig inaktiv metabolit, M1. I et massebalancestudie var M1 og M10 (de efterfølgende dannede M1-glucuronider) de væsentligste cirkulerende metabolitter.
In a mass balance study, M1 and M10 (the subsequently formed M1 glucuronides) were the major circulating metabolites.
Anvendes med forsigtighed til disse patienter (se pkt.
There are no data in patients with severe hepatic impairment; use with caution in these patients (see section 5.2).
Hæmning af hepatiske optagelsestransportører (OATP1B1, OATP1B3 og OCT1) Hverken niraparib eller M1 er en hæmmer af organisk aniontransportpolypeptid 1B1 (OATP1B1) eller 1B3 (OATP1B3).
Inhibition of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1) Neither niraparib nor M1 is an inhibitor of organic anion transport polypeptide 1B1 (OATP1B1) or 1B3 (OATP1B3).
Tilbagehold Zejula i maksimalt 28 dage, og overvåg blodtallene ugentligt, indtil trombocyttallet igen er ≥ 100.000/µl.
• Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥ 100,000/µL.
Hvis du har taget for meget Zejula
If you take more Zejula than you should
Der er ikke udført studier af niraparibs reproduktions- og udviklingstoksicitet.
Reproductive and developmental toxicity studies have not been conducted with niraparib.
• Næseblod
• Nose bleed
Efter den første måned bør det komplette blodtal overvåges månedligt og derefter med jævne mellemrum (se pkt.
After the first month, it is recommended to monitor CBCs monthly and periodically after this time (see section 4.4).
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) • Nedsat antal hvide blodlegemer (leukopeni)
Common (may affect up to 1 in 10 people) Reduction in the number of white cells in the blood (leukopenia) Talk to your doctor if you get any other side effects.
Niraparib som et substrat for renale optagelsestransportører (OAT1, OAT3 og OCT2) Hverken niraparib eller M1 er et substrat for organisk aniontransportør 1 (OAT1), 3 (OAT3) og organisk kationtransportør 2 (OCT2).
Niraparib as a substrate of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 is a substrate of organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
PRAC konkluderede derfor, at febril neutropeni bør tilføjes som en ny bivirkning under pkt.
Therefore, the PRAC concluded that “febrile neutropenia” should be added as a new adverse drug reaction in section 4.8 of the SmPC with the frequency “uncommon.” The package leaflet should be updated accordingly.
Hæmning af renale optagelsestransportører (OAT1, OAT3 og OCT2) Hverken niraparib eller M1 hæmmer organisk aniontransportør 1 (OAT1), 3 (OAT3) og organisk kationtransportør 2 (OCT2).
Inhibition of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 inhibits organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Træthed, asteni
Fatigue, asthenia
Alle blødningshændelser, der var samtidige med trombocytopeni, var af sværhedsgrad 1 eller 2, med undtagelse af ét tilfælde af petekkier og hæmatom af grad 3, der blev observeret samtidig med et alvorligt tilfælde af pancytopeni.
In the NOVA study, 48 of 367 (13 %) of patients experienced bleeding with concurrent thrombocytopenia; all bleeding events concurrent with thrombocytopenia were Grade 1 or 2 in severity except for one event of Grade 3 petechiae and haematoma observed concurrently with a serious adverse event of pancytopenia.
• Vægttab
• Dizziness
Dosisændringer ved hæmatologiske bivirkninger
Dose modifications for haematologic adverse reactions
Rygsmerter, artralgi
Back pain, arthralgia
Der foreligger ingen data om patienter med svært nedsat nyrefunktion eller nyresygdom i slutfasen, som får hæmodialyse.
There are no data in patients with severe renal impairment or end stage renal disease undergoing haemodialysis; use with caution in these patients (see section 5.2).
I det kliniske program blev anæmi håndteret ved hjælp af laboratorieovervågning, dosisjustering (se pkt.
In the clinical programme, anaemia was managed with laboratory monitoring, dose modification (see section 4.2), and where appropriate with red blood cell transfusions.
Tilbagehold Zejula i maksimalt 28 dage, og overvåg det komplette blodtal ugentligt, indtil trombocyttallet igen er ≥ 100.000/µl.
• Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to
• Oppustet mave
• Stomach pain
• Øjenbetændelse
• Pink eye
Lave blodtal kan i sjældne tilfælde være tegn på alvorligere problemer med knoglemarven, såsom "myelodysplastisk syndrom" (MDS) eller "akut myeloid leukæmi" (AML).
Myelodysplastic syndrome/acute myeloid leukaemia Rarely, low blood-cell counts may be a sign of more serious problems with the bone marrow such as
Dosisjusteringer ved bivirkninger
Dose adjustments for adverse reactions
Niraparib som et substrat for hepatiske optagelsestransportører (OATP1B1, OATP1B3 og OCT1) Hverken niraparib eller M1 er et substrat for organisk aniontransportpolypeptid 1B1 (OATP1B1), 1B3 (OATP1B3) eller organisk kationtransportør 1 (OCT1).
Neither niraparib nor M1 is a substrate of organic anion transport polypeptide 1B1 (OATP1B1), 1B3 (OATP1B3), or organic cation transporter 1 (OCT1).
• Svaghed
• Feeling of weakness
Europa-Kommissionen traf en afgørelse den 10. juni 2016.
The European Commission issued a decision on 10 June 2016.
10. juni 2016
10 June 2016
Virksomheden ønskede at få godkendelsen anerkendt i Bulgarien, Kroatien, Frankrig, Tyskland, Irland, Italien, Nederlandene, Polen, Portugal, Rumænien, Slovenien, Spanien og Det Forenede Kongerige (de "berørte medlemsstater").
The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the ‘concerned Member States').
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den belgiske sundhedsstyrelse indbragte sagen til CVMP med henblik på voldgift den 29. september 2015.
However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015.
Den 17. marts 2016 gennemførte Det Europæiske Lægemiddelagentur (Agenturet) en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet CattleMarker IBR Inactivated, emulsion til injektion til kvæg (herefter kaldet CattleMarker IBR Inactivated).
On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated).
Hvad er CattleMarker IBR Inactivated?
What is CattleMarker IBR Inactivated?
Zoetis Belgium SA indsendte en ansøgning om gensidig anerkendelse af CattleMarker IBR Inactivated på grundlag af den oprindelige godkendelse udstedt af Belgien.
Zoetis Belgium SA submitted an application for CattleMarker IBR Inactivated for mutual recognition on the basis of the initial authorisation granted by Belgium.
Hvorfor blev CattleMarker IBR Inactivated vurderet?
Why was CattleMarker IBR Inactivated reviewed?