natgillin/translations-raw huggingface dataset:
Vectibix 'effekt hos patienter med metastatisk colorectal cancer (mCRC), der havde sygdomsprogression under eller efter tidligere kemoterapi, blev undersøgt i et randomiseret, kontrolleret forsøg (463 patienter) og open- label, enkeltgruppe- forsøg (384 patienter).
The efficacy of Vectibix in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in a randomised controlled trial (463 patients) and open-label, single-arm trials (384 patients).
Vectibix 'sikkerhed for patienter med mCRC, der fik mindst én dosis Vectibix, blev undersøgt hos 920 patienter.
The safety of Vectibix in patients with mCRC who received at least one dose of Vectibix was evaluated in 920 patients.
7 tumorer og i kombination med kemoterapi med og uden bevacizumab til patienter med mCRC eller i kombination med kemoterapi til patienter med ikke- småcellet lungecancer.
Additional studies were performed with Vectibix as a single agent in patients with other solid tumours and in combination with chemotherapy with and without bevacizumab in patients with mCRC or in combination with chemotherapy in patients with non-small cell lung cancer.
Et multinationalt, randomiseret, kontrolleret forsøg blev udført med 463 patienter med EGFR - udtrykkende metastatisk carcinom i colon eller rectum efter bekræftet manglende effekt af regimener, der indeholdt oxaliplatin og irinotecan.
7 A multinational, randomised, controlled trial was conducted in 463 patients with EGFR-expressing metastatic carcinoma of the colon or rectum after confirmed failure of oxaliplatin and irinotecan- containing regimens.
Patienterne blev randomiseret i forholdet 1: 1 til at få Vectibix ved en dosis på 6 mg/ kg indgivet én gang hver anden uge plus bedste understøttende behandling (herunder ikke kemoterapi) (BSC) eller BSC alene.
Patients were randomised 1:1 to receive Vectibix at a dose of 6 mg/ kg given once every two weeks plus best supportive care (not including chemotherapy) (BSC) or BSC alone.
Ved sygdomsprogression kunne patienterne, der fik BSC alene, fortsætte i et sideløbende forsøg og få Vectibix ved en dosis på 6 mg/ kg indgivet én gang hver anden uge.
Upon disease progression BSC alone patients were eligible to crossover to a companion study and receive Vectibix at a dose of 6 mg/ kg given once every two weeks.
Af de 463 patienter var 63% mænd.
Of 463 patients, 63% were male.
Medianalderen var 62 år (fra 27 til 83 år), og 99% var kaukasiske.
The median age was 62 years (range 27 to 83), and 99% were Caucasian.
396 (86%) patienter havde en ECOG Performance Status ved baseline på 0 eller 1.
Three hundred and ninety-six (86%) patients had a baseline ECOG Performance Status of 0 or 1.
67 procent af patienterne havde coloncancer, og 33% havde rectalcancer.
Sixty-seven percent of patients had colon cancer and 33% had rectal cancer.
Det primære endpoint var progressionsfri overlevelse (PFS).
The primary endpoint was progression-free survival (PFS).
I en analyse, hvor der justeredes for potential bias fra ikke skemalagte vurderinger, var raten af sygdomsprogression eller dødsfald hos patienterne, der fik Vectibix, reduceret med 40% sammenlignet med patienter, som fik BSC (risikoratio = 0, 60 (95% CI 0, 49; 0, 74), stratificeret log- rank p < 0, 0001).
In an analysis adjusting for potential bias from unscheduled assessments, the rate of disease progression or death in patients who received Vectibix was reduced by 40% relative to patients that received BSC [Hazard Ratio = 0.60, (95% CI 0.49, 0.74), stratified log-rank p < 0.0001].
Der sås ingen forskel i PFS - mediantider, idet der forekom progression hos over 50% af patienterne i begge behandlingsgrupper før første skemalagte besøg.
There was no difference seen in median PFS times as more than 50% of patients progressed in both treatment groups before the first scheduled visit.
De progressionsfri overlevelsesrater ved første skemalagte besøg (uge 8) var 45, 5% for Vectibix plus BSC og 24, 6% for BSC alene, en difference på 20, 9% [95% CI:
The progression-free survival rates at the first scheduled visit (week 8) were 45.5% on Vectibix plus BSC and 24.6% on BSC alone, a difference of 20.9% [95% CI:
12, 4; 29, 4].
12.4, 29.4].
Der sås ingen difference mht. generel overlevelse.
No difference was seen in overall survival.
Dette kan skyldes, at patienter blandt dem, der var randomiseret til BSC, overførtes til panitumumab efter progression.
This may be due to patients receiving panitumumab after progression among those randomized to BSC.
Tumorresponsen i henhold til de modificerede RECIST- kriterier blev fastlagt ved hjælp af en central gennemgang.
Tumour response according to modified-RECIST criteria was determined by central review.
Generelt havde 9, 5% (95% CI:
Overall, 9.5% [95% CI:
6, 1; 14, 1) af patienterne på Vectibix plus BSC og 0% (95% CI:
6.1, 14.1] Vectibix plus BSC patients, and 0% [95% CI:
0, 0; 1, 6) af patienterne på BSC alene en bekræftet objektiv respons (delvis respons) med stabil sygdom hos henholdsvis 26% og 10% af patienterne.
0.0, 1.6] BSC alone patients had a confirmed objective response (partial response), with stable disease in 26% and 10% patients, respectively.
Blandt de 176 patienter, der fik Vectibix efter progression på BSC alene, var responsraten (investigators vurdering) 11, 4% (95% CI:
Among the 176 patients who received Vectibix after progression on BSC alone, the response rate (investigator assessment) was 11.4% (95% CI:
PFS – alle patienter
PFS – All Patients
Behandlingsgruppe Events
Vectibix+BSC
Vectibix + BSC 193 / 231 (84( 84) 8. 0 8. 0
Events / N (%) in Weeks 193 / 231 (84) 8.0
Vectibix+BSC BSC alene
Proportion Event-Free
60%
60% Hazard ratio = 0.60
50% Risikorati = 0. 60
50% 40%
0% Forsøgspersoner med risiko: risk:
Subjects at risk:
Vectibix+BSC Vectibix+BSC
Vectibix+BSC
Ikke skemalagte tumorvurderinger er flyttet til nærmeste skemalagte tid.
The relationship between KRAS mutation status determined in archived paraffin embedded tumour tissue and clinical outcome was evaluated in a retrospective analysis.
8 Forbindelsen mellem KRAS- mutationsstatus, der blev fastlagt ud fra arkiveret paraffinindlejret tumorvæv, og det kliniske udfald blev evalueret i en retrospektiv analyse.
8 allele-specific polymerase chain reaction.
427 (92%) patienter var evaluerbare for så vidt angår KRAS - status, og af disse havde 184 patienter mutationer.
427 (92%) patients were evaluable for KRAS status of which 184 had mutations.
I en analyse, hvor der justeredes for ikke - skemalagte vurderinger, var risikoratio for PFS 0, 49 (95% CI:
In an analysis adjusting for potential bias from unscheduled assessments the hazard ratio for PFS was 0.49 (95% CI:
0, 37- 0, 65) i panitumumabs favør i gruppen med KRAS- vildtypen og 1, 07 (95% CI:
0.37-0.65) in favour of panitumumab in the KRAS wild-type group and 1.07 (95% CI:
0, 77- 1, 48) i gruppen med KRAS- mutationer.
0.77-1.48) in the KRAS mutant group.
Forskellen i PFS- median i gruppen med KRAS- vildtypen var 8 uger.
The difference in median PFS in the KRAS wild-type group was 8 weeks.
De progressionsfri overlevelsesrater for første skemalagte besøg (uge 8) i gruppen med KRAS- vildtypen var 59, 7% for Vectibix plus BSC og 21, 0% for BSC alene, en difference på 38, 7% (95% CI:
The progression-free survival rates at the first scheduled visit (week 8) in the KRAS wild-type group were 59.7% on Vectibix plus BSC and 21.0% on BSC alone, a difference of 38.7% [95% CI:
27, 4; 50, 0).
27.4, 50.0].
Forskellen i PFS- median i gruppen med KRAS- mutationer var 0 uger.
The difference in median PFS in the KRAS mutant group was 0 weeks.
De progressionsfri overlevelsesrater ved første skemalagte besøg (uge 8) i gruppen med KRAS- vildtypen var 21, 4% for Vectibix plus BSC og 28, 0% for BSC alene, en difference på - 6, 6% (95% CI: - 19, 0; 5, 9).
The progression-free survival rates at the first scheduled visit (week 8) in the KRAS mutant group were 21.4% on Vectibix plus BSC and 28.0% on BSC alone, a difference of -6.6% [95% CI: -19.0, 5.9].
Der var ingen differencer i den generelle overlevelse i nogen af de to grupper.
There were no differences in overall survival seen in either group.
I gruppen med KRAS- vildtypen var responsraten 17% for panitumumab og 0% for BSC.
In the KRAS wild-type group the response rate was 17% for panitumumab and 0% for BSC.
I gruppen med KRAS- mutationer var der ingen respons i nogen af de to behandlingsarme.
In the KRAS mutant group there were no responses in either treatment arm.
Raterne for stabil sygdom i gruppen med KRAS - vildtypen var 34% for panitumumab og 12% for BSC.
Stable disease rates in the KRAS wild-type group were 34% for panitumumab and 12% for BSC.
Raterne for stabil sygdom i gruppen med KRAS mutationer var 12% for panitumumab og 8% for BSC.
The stable disease rates in the KRAS mutant group were 12% for panitumumab and 8% for BSC.
Responsraten (investigators vurdering) for patienter, der overgik til panitumumab efter progression på BSC alene, var 22% (95% CI:
Response rate (investigator assessment) in patients that crossed over to panitumumab after progression on BSC alone was 22% (95% CI:
14, 0; 31, 9) for dem, der havde tumorer med KRAS- vildtypen, og 0% (95% CI:
14.0, 31.9) for those with KRAS wild-type tumours and 0% (95% CI:
0, 0; 4, 3) for dem, der havde tumorer med KRAS- mutationer.
0.0, 4.3) for those with mutant KRAS tumours.
PFS – patienter med KRAS- vildtypen og KRAS- mutationer
PFS – Patients with mutant and wild type KRAS Wild Type KRAS
Behandlingsgruppe Events
Events / N (%) in Weeks
Hændelser/ N (%) Median i uger / N (%) in Weeks
90%
Vectibix+BSC Vectibix + BSC 115 / 124 (93) 115/ 124 (93) 16. 0 16. 0 90% BSC Alone
Vectibix+BSC
BSC alene
BSC Alone
114 /
114 / 119 (96)
119 (96) 114/ 119 (96) 8. 0 8. 0
8.0
Proportion Event- Free Hændelsesfri andel
Proportion Event-Free
60% Risikorati = 0. 49
Hazard ratio = 0.49
0% Forsøgspersoner med at risk:
Subjects at risk:
8 10 12 14 16 18 20 22 24 26 28 30 32 34 36
8 10 12 14 16 18 20 22 24 26 28 30 32 34
38 40 42 44 46 48 50 52
36 38 40 42 44 46 48 50 52 Weeks
44 44 44 24 20 2
44 44 44 24 20 2
BSC alene BSC Alone
BSC Alone
1
15 15 11 11 9 9 6 6 6 6 5
9 118 11
11
6 116 11
9 118 11
4 19 19
6 116 114 19 19 1
1
5 15 11 11 9 9 6 6 6 6 5 4 3 3 2
5 15 11 11 9 9 6 6 6 6 5 4
4 19 19 15 15 11 11 9 9 6 6 6 6 5 4
Ikke skemalagte tumorvurderinger er flyttet til nærmeste skemalagte tid.
Unscheduled tumour assessments were moved to the nearest scheduled timepoint
9 KRAS- mutationer
9 Mutant KRAS
Behandlingsgruppe Events / N (%) in Weeks Hændelser/ N (%) Median i uger Vectibix+BSC
Events / N (%) in Weeks
Vectibix + BSC BSC alene
Vectibix+BSC
76/ 84 (90)) 84 (90
76 / 84 (90)
95/ 100 (95)) 100 (95
95 / 100 (95)
Forsøgspersoner med risiko: uger Weeks Vectibix+BSC
34 36 38 40 42 44 46 48 50 52 Weeks
5 5 5 5 4 4
9 6 6 5 5 5
PACCE- undersøgelsen:
The PACCE study:
I denne randomiserede, åbne, kontrollerede kliniske undersøgelse blev der givet kemoterapi (oxaliplatin eller irinotecan) og bevacizumab med og uden panitumumab som førstevalgsbehandling til patienter med metastatisk colorectal cancer.
In this randomised, open label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and bevacizumab were given with and without panitumumab in the first line treatment of patients with metastatic colorectal cancer.
Panitumumab- behandlingen blev indstillet på grund af en statistisk signifikant reduktion i PFS hos patienter, som fik panitumumab, observeret ved en interimanalyse.
Panitumumab treatment was discontinued due to a statistically significant reduction in PFS in patients receiving panitumumab observed in an interim analysis.
Risikoraten for PFS var 1, 44 (95% CI:
The hazard ratio for PFS was 1.44 (95% CI:
8, 3, 9, 5) og 10, 5 (95% CI:
Median PFS was 8.8 (95% CI:
9, 4, 12, 0) måneder i hhv. panitumumab- armen og ikke - panitumumab- armen.
8.3, 9.5) and 10.5 (95% CI 9.4, 12.0) months in the panitumumab and the non-panitumumab arm, respectively.
Der var en stigning i dødeligheden i Vectibix- armen.
There was an increase in mortality in the Vectibix arm.
Risikoraten for den overordnede overlevelse var 1, 56 (95% CI:
The hazard ratio for overall survival was 1.56 (95% CI:
Den overordnede overlevelsesmedian var 18, 4 (95% CI:
Median overall survival was 18.4 (95% CI:
13, 8, ikke vurderbar) i panitumumab- armen og ikke vurderbar i ikke- panitumumab- armen.
13.8, not estimable) in the panitumumab arm and not estimable in the non-panitumumab arm.
Dette lægemiddel er godkendt under ” betingede omstændigheder ”.
This medicinal product has been authorised under a “ conditional approval” scheme.
Dette gælder især data, som bekræfter effekten hos patienter med tumorer med KRAS- vildtypen, hvilket aktuelt understøttes af en retrospektiv analyse.
This means that further evidence on this medicinal product is awaited, in particular data are required to confirm the effect in patients with wild-type KRAS tumours which is currently supported by a retrospective analysis.
Yderligere evidens afventes også vedrørende effekten af panitumumab i kombination med kemoterapi om PFS hos patienter med tumorer med KRAS- vildtypen.
Further evidence is also awaited regarding the effect of panitumumab in combination with chemotherapy on PFS in patients with wild-type KRAS tumours.
Studier, som undersøger denne effekt, er i gang i øjeblikket.
Studies investigating this effect are currently ongoing.
Vectibix indgivet som et enkelt middel eller kombineret med kemoterapi udviser en ikke- lineær farmakokinetik.
Vectibix administered as a single agent or in combination with chemotherapy exhibits nonlinear pharmacokinetics.
Efter indgivelse af en enkelt dosis panitumumab som 1 times infusion øgedes area under the concentration- curve (AUC) mere end på en dosisproportionel måde, og clearancen (CL) af panitumumab faldt fra 30, 6 til 4, 6 ml/ dag/ kg, da dosis steg fra 0, 75 til 9 mg/ kg.
Following a single-dose administration of panitumumab as a 1-hour infusion, the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner and clearance (CL) of panitumumab decreased from 30.6 to 4.6 ml/ day/ kg as the dose increased from 0.75 to 9 mg/ kg.
Ved doser over 2 mg/ kg stiger AUC for panitumumab dog på en omtrent dosisproportionel måde.
However, at doses above 2 mg/ kg, the AUC of panitumumab increases in an approximately dose-proportional manner.
Efter det anbefalede dosisregimen (6 mg/ kg indgivet én gang hver 2. uge som 1 times infusion) nåede koncentrationerne af panitumumab steady- state- niveauerne ved den tredje infusion med middel - (± SD) maksimum - og minimumskoncentrationer på henholdsvis 213 ± 59 og 39 ± 14 µg/ ml.
Following the recommended dose regimen (6 mg/ kg given once every 2 weeks as a 1-hour infusion), panitumumab concentrations reached steady-state levels by the third infusion with mean (± SD) peak and trough concentrations of 213 ± 59 and 39 ± 14 mcg/ ml, respectively.
Middel - (± SD) - AUC0- tau og - CL var henholdsvis 1306 ± 374 µg/ dag/ ml og 4, 9 ± 1, 4 ml/ kg/ dag.
The mean (± SD) AUC0-tau and CL were 1306 ± 374 mcg• day/ ml and 4.9 ± 1.4 ml/ kg/ day, respectively.
Elimineringstiden var cirka 7, 5 dage (interval:
The elimination half-life was approximately 7.5 days (range:
3, 6 til 10, 9 dage).
3.6 to 10.9 days).
10 Der blev udført en populationsfarmakokinetisk analyse for at udforske de mulige indvirkninger af udvalgte kovariater på panitumumabs farmakokinetik.
10 A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates on panitumumab pharmacokinetics.
Resultaterne tyder på, at alder, køn, tumortype, race, lever - og nyrefunktion, kemoterapeutiske midler og EGFR- ekspression i tumorceller ikke har nogen åbenbar indvirkning på panitumumabs farmakokinetik.
Results suggest that age, gender, tumour type, race, hepatic function, renal function, chemotherapeutic agents, and EGFR expression in tumour cells had no apparent impact on the pharmacokinetics of panitumumab.
Der er ikke udført nogen kliniske forsøg med henblik på at undersøge panitumumabs farmakokinetik hos patienter med nyre - eller leversvækkelse.
No clinical studies have been conducted to examine the pharmacokinetics of panitumumab in patients with renal or hepatic impairment.
Der blev ikke observeret nogen aldersrelaterede forskelle i panitumumabs farmakokinetik i kliniske forsøg med patienter i alderen 26 til 85 år.
No age-related differences in pharmacokinetics of panitumumab were observed in clinical studies in patients 26 to 85 years of age.
Hududslæt og diaré var de væsentligste fund, der blev observeret i toksicitetsforsøg med gentagen dosis af op til 26 ugers varighed i cynomolgusaber.
Skin rash and diarrhoea were the major findings observed in repeat-dose toxicity studies of up to 26 weeks duration in cynomolgus monkeys.
Hududslættet og diaréen, der blev observeret hos aber, betragtes som værende relateret til panitumumabs farmakologiske virkning og svarer til de toksiciteter, der er observeret med andre anti- EGFR - hæmmere.
The skin rash and diarrhoea observed in monkeys are considered related to the pharmacological action of panitumumab and are consistent with the toxicities observed with other anti-EGFR inhibitors.
Der er ikke udført forsøg til evaluering af panitumumabs mutagene og karcinogene potentiale.
Studies to evaluate the mutagenic and carcinogenic potential of panitumumab have not been performed.
Dyreforsøg er utilstrækkelige hvad angår embryoets/ fosterets udvikling, eftersom eksponeringsniveauerne af panitumumab for fosteret ikke er undersøgt.
Animal studies are insufficient with respect to embryo-foetal development since foetal panitumumab exposure levels were not examined.
Det er blevet påvist, at panitumumab forårsager abort og/ eller fosterdød hos cynomolgusaber, når det indgives i løbet af organdannelsesperioden i doser omtrent svarende til den anbefalede humane dosis.
Panitumumab has been shown to cause foetal abortions and/ or foetal deaths in cynomolgus monkeys when administered during the period of organogenesis at doses approximately equivalent to the recommended human dose.
Der er ikke udført formelle fertilitetsforsøg med mænd; mikroskopisk undersøgelse af reproduktive organer hos cynomolgusaber af hankøn i undersøgelser af toksicitet ved gentagen dosis med doser på op til 5 gange den humane dosis på mg/ kg- basis afslørede imidlertid ingen forskel sammenlignet med kontrolgruppen af hanaber.
Formal male fertility studies have not been conducted; however, microscopic evaluation of male reproductive organs from repeat-dose toxicity studies in cynomolgus monkeys at doses up to approximately 5-fold the human dose on a mg/ kg basis, revealed no differences compared to control male monkeys.
Fertilitetsundersøgelser udført med cynomolgusaber af hunkøn viste, at panitumumab måske kan resultere i forlænget menstruationscyklus og/ eller amenorré og reduceret graviditetsrate, hvilket forekom ved alle evaluerede doser.
Fertility studies conducted in female cynomolgus monkeys showed that panitumumab may produce prolonged menstrual cycle and/ or amenorrhea and reduced pregnancy rate which occurred at all doses evaluated.
Der er ikke udført nogen dyreforsøg med panitumumab med henblik på den præ - og postnatale udvikling.
No pre- and post-natal development animal studies have been conducted with panitumumab.
Alle patienter skal inden iværksættelse af behandlingen med Vectibix rådgives om den mulige risiko ved panitumumab for så vidt angår den præ - og postnatale udvikling.
All patients should be advised regarding the potential risk of panitumumab on pre- and post-natal development prior to initiation of Vectibix therapy.
Natriumklorid Natriumacetattrihydrat Iseddikesyre (til regulering af pH) Vand til injektion
Sodium chloride Sodium acetate trihydrate Acetic acid, glacial (for pH-adjustment) Water for injection.
11 Vectibix indeholder ikke noget antimikrobielt konserveringsmiddel eller bakteriehæmmende stof.
Vectibix does not contain any antimicrobial preservative or bacteriostatic agent.
Hvis opløsningen ikke anvendes straks, er opbevaringstid og - forhold før anvendelse brugerens ansvar, og opbevaringstiden må ikke overstige 24 timer ved 2 °C - 8 °C
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C to 8°C.
Hætteglas (type I- glas) til engangsbrug med en elastomerprop, aluminiumsforsegling og en aftagelig plasthætte.
Single-use vial (type I glass) with an elastomeric stopper, aluminium seal and flip-off plastic cap.
Ét hætteglas indeholder:
One vial contains:
100 mg panitumumab i 5 ml, 200 mg panitumumab i 10 ml eller 400 mg panitumumab i 20 ml koncentrat til infusionsvæske, opløsning.
100 mg of panitumumab in 5 ml, 200 mg panitumumab in 10 ml, or 400 mg panitumumab in 20 ml of concentrate for solution for infusion.
Pakning med 1 hætteglas med 5 ml.
Pack of 1 vial containing 5 ml.
Pakning med 1 hætteglas med 10 ml.
Pack of 1 vial containing 10 ml.
Pakning med 1 hætteglas med 20 ml.
Pack of 1 vial containing 20 ml.
Vectibix skal fortyndes i en 0, 9% natriumchloridinjektion af en læge eller sygeplejerske vha. aseptisk teknik.
Vectibix should be diluted in 0.9% sodium chloride injection by healthcare professional using aseptic technique.
Udtag den nødvendige mængde Vectibix til en dosis på 6 mg/ kg.
Withdraw the necessary amount of Vectibix for a dose of 6 mg/ kg.
Fortynd i en samlet mængde på 100 ml.
Dilute in a total volume of 100 ml.
Den endelige koncentration bør ikke overskride 10 mg/ ml.
The final concentration should not exceed 10 mg/ ml.
4. 2).
Doses higher than 1000 mg should be diluted in 150 ml 0.9% sodium chloride injection (see section 4.2).
Der er ikke observeret nogen uforligeligheder mellem Vectibix og 0, 9% natriumchloridinjektion i polyvinylchloridposer eller polyolefinposer.
No incompatibilities have been observed between Vectibix and 0.9% sodium chloride injection in polyvinyl chloride bags or polyolefin bags.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til de lokale retningslinjer.
Any unused product or waste material should be disposed of in accordance with local requirements.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Farmakovigilanssystem Indehaveren af markedsføringstilladelsen skal sikre, at farmakovigilanssystemet som beskrevet i version 3 i Modul 1. 8. 1. i ansøgningen om markedsføringstilladelse er på plads og fungerer, inden og imens produktet er på markedet.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Risikostyringsplan Indehaveren af markedsføringstilladelsen påtager sig at gennemføre undersøgelserne og yderligere farmakovigilans- aktiviteter, der er nærmere beskrevet i farmakovigilansplanen og som aftalt i version 3 af risikostyringsplanen i Modul 1. 8. 2. i ansøgningen om markedsføringstilladelse og eventuelle efterfølgende opdateringer af risikostyringsplanen, som er godkendt af CHMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
15 C.
15 C.