natgillin/translations-raw huggingface dataset:
Forbedring af surrogatmarkører for betacellefunktionen, inklusive HOMA - (Homøostatisk modelvurdering -), proinsulin/ insulin ratio samt resultater fra en frequently sampled meal tolerance test blev observeret.
Improvement of surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Den observerede incidens af hypoglykæmi hos de patienter, der blev behandlet med TESAVEL var den samme som for placebo.
The observed incidence of hypoglycaemia in patients treated with TESAVEL was similar to placebo.
Desuden var reduktionerne i HbA1c og FPG for sitagliptin, sammenlignet med placebo, generelt de samme som dem, der er observeret i andre monoterapiundersøgelser hos patienter med normal nyrefunktion (se afsnit 5. 2).
In addition, the reductions in HbA1c and FPG with sitagliptin compared to placebo were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
I to 24- ugers undersøgelser gav sitagliptin 100 mg én gang dagligt som supplerende behandling, den ene i kombination med metformin og den anden med pioglitazon, en signifikant glykæmisk forbedring, sammenlignet med placebo.
Sitagliptin 100 mg once daily provided significant improvements in glycaemic parameters compared with placebo in two 24-week studies of sitagliptin as add-on therapy, one in combination with metformin and one in combination with pioglitazone.
I en 24- ugers placebokontrolleret faktoriel undersøgelse af initial behandling gav sitagliptin 50 mg to gange dagligt i kombination med metformin (500 mg eller 1. 000 mg to gange dagligt) en signifikant
In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
HbA1c resultater i placebokontrollerede monoterapi - og kombinationsterapiundersøgelser *
HbA1c results in placebo-controlled monotherapy and combination therapy studies*
Undersøgelse
Mean change from
Gennemsnitlig baseline HbA1c (%)
baseline HbA1c (%)
Gennemsnitlig ændring fra baseline HbA1c (%) i 24. uge †
baseline HbA1c (%) † at Week 24
Placebokontrolleret gennemsnitlig ændring (%) i 24. uge † (95% CI)
Week 24† (95% CI)
Monoterapiundersøgelser Sitagliptin 100 mg én gang dagligt§
Monotherapy Studies Sitagliptin 100 mg once daily§
(N=193) Sitagliptin 100 mg én gang dagligt (N=229) Kombinationsterapiundersøgelser Sitagliptin 100 mg én gang dagligt
(N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies Sitagliptin 100 mg once daily added to
(- 0, 8; - 0, 4) - 0, 8 ‡ (- 1, 0; - 0, 6) - 0, 7 ‡
(-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
som supplement til metforminbehandling (N=453) Sitagliptin 100 mg én gang dagligt
ongoing metformin therapy (N=453)
- 0, 7
(-0.8, -0.5)
(- 0, 8; - 0, 5) - 0, 7 ‡
8
som supplement til pioglitazonbehandling (N=163) Sitagliptin 100 mg én gang dagligt
Sitagliptin 100 mg once daily added to -0.7‡ ongoing pioglitazone therapy (N=163) Sitagliptin 100 mg once daily added to
som supplement til glimepirid + metforminbehandling (N=115) Initialbehandling (to gange
ongoing glimepiride + metformin therapy (N=115) Initial therapy (twice daily):
Sitagliptin 50 mg + metformin 500 mg (N=183) Initialbehandling (to gange
Sitagliptin 50 mg + metformin 500 mg (N=183) Initial therapy (twice daily):
(- 1, 8; - 1, 3)
(-1.8, -1.3)
- 2, 1 ‡ (- 2, 3; - 1, 8)
-2.1‡ (-2.3, -1.8)
Population; alle behandlede patienter (analyse med henblik på behandling) † Mindste kvadratsmetode betyder justeret mht. tidligere antihyperglykæmisk behandlingsstatus og baseline- værdi. ‡ p < 0, 001 sammenlignet med placebo eller placebo + kombinationsbehandling. § HbA1c (%) i 18. uge
* All Patients Treated Population (an intention-to-treat analysis). † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value. ‡ p < 0.001 compared to placebo or placebo + combination treatment. § HbA1c (%) at week 18.
I en undersøgelse af effekt og sikkerhed af tillægsbehandling med TESAVEL 100 mg én gang dagligt eller glipizid (et sulfonylurinstof) til patienter med utilstrækkelig glykæmisk kontrol på metforminmonoterapi, var sitagliptin sammenlignelig med glipizid mht. reduktion af HbA1c.
In a study comparing the efficacy and safety of the addition of TESAVEL 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
9 effektiviteten af insulinsyntese og - sekretion, med sitagliptin og forværredes med glipizidbehandling.
In this study, the proinsulin to insulin ratio, a marker of efficiency of insulin synthesis and release, improved with sitagliptin and deteriorated with glipizide treatment.
Eftersom samtidig administration af et fedtrigt måltid sammen med TESAVEL ikke havde nogen effekt på farmakokinetikken, kan TESAVEL administreres med eller uden mad.
Since coadministration of a high-fat meal with TESAVEL had no effect on the pharmacokinetics, TESAVEL may be administered with or without food.
10 Nyreinsufficiens I en åben undersøgelse med enkeltdosis blev farmakokinetikken for en reduceret dosis sitagliptin (50 mg) vurderet hos patienter med varierende grader af kronisk nyreinsufficiens sammenlignet med normale raske kontrolpersoner.
Renal insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50-mg) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Undersøgelsen omfattede patienter med nyreinsufficiens klassificeret på basis af kreatinin- clearance som mild (50 til < 80 ml/ min), moderat (30 til < 50 ml/ min) og svær (< 30 ml/ min) samt patienter med ESRD i hæmodialyse.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to < 80 ml/ min), moderate (30 to < 50 ml/ min), and severe (< 30 ml/ min), as well as patients with end-stage renal disease (ESRD) on hemodialysis.
TESAVEL anbefales ikke til patienter med moderat eller svær nyreinsufficiens, inklusive patienter med ESRD, da erfaringen med disse patientgrupper er for begrænset (se afsnit 4. 2.).
(See section 4.2.)
Leverinsufficiens Dosisjustering af TESAVEL er ikke nødvendig hos patienter med mild eller moderat leverinsufficiens (Child- Pugh score 9).
Hepatic insufficiency No dosage adjustment for TESAVEL is necessary for patients with mild or moderate hepatic insufficiency (Child-Pugh score ≤ 9).
Eftersom hepatotoksicitet har
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
11 vist sig at korrelere med induktion af hepatisk neoplasi hos rotter, var denne øgede forekomst af hepatiske tumorer sandsynligvis sekundær til kronisk hepatisk toksicitet ved denne høje dosis.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Der blev ikke observeret bivirkninger i fertiliteten hos han - og hunrotter, der blev behandlet med sitagliptin før og under parringsperioden.
No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
6. 1 Fortegnelse over hjælpestoffer
Tablet core: microcrystalline cellulose (E460)
Tabletkerne Mikrokrystallinsk cellulose (E460) Calciumhydrogenphosphat, vandfrit (E341) Croscarmellosenatrium (E468) Magnesiumstearat (E470b) Natriumstearylfumarat
11 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
12 6. 6 Særlige forholdsregler ved bortskaffelse
6.6 Special precautions for disposal
14 Patienter med nyreinsufficiens Til patienter med mild nyreinsufficiens (kreatinin- clearance [CrCl] ≥50 ml/ min,), er dosisjustering for TESAVEL ikke nødvendig.
14 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
Hypersensitivitetsreaktioner Efter markedsføring er der rapporteret om alvorlige hypersensitivitetsreaktioner hos patienter, der er blevet behandlet med Tesavel.
Hypersensitivity Reactions Postmarketing reports of serious hypersensitivity reactions in patients treated with TESAVEL have been reported.
Disse reaktioner startede inden for de første 3 måneder efter initiering af behandling med Tesavel, og nogle rapporter kom efter første dosis.
Onset of these reactions occurred within the first 3 months after initiation of treatment with TESAVEL, with some reports occurring after the first dose.
Hvis der er mistanke om en hypersensitivitetsreaktion, skal Tesavel seponeres, og det skal vurderes, om der er andre potentielle årsager til hændelsen.
If a hypersensitivity reaction is suspected, discontinue TESAVEL, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
4. 8).
4.5 Interaction with other medicinal products and other forms of interaction
15 4. 5 Interaktion med andre lægemidler og andre former for interaktion
15 Metformin:
4. 8 Bivirkninger
16 4.8 Undesirable effects
I 9 store kliniske undersøgelser af op til 2 års varighed er mere end 2. 700 patienter blevet behandlet med TESAVEL 100 mg dagligt, alene eller i kombination med metformin, et sulfonylurinstof (med eller uden metformin) eller en PPARγ agonist.
In 9 large clinical trials of up to 2 years in duration, over 2700 patients have received treatment with TESAVEL 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin) or a PPARγ agent.
I en supplerende 1- års undersøgelse af sitagliptin 100 mg én gang dagligt i kombination med metformin var incidensen af formodede bivirkninger hos de patienter, der blev behandlet med sitagliptin/ metformin sammenlignet med de patienter, der fik et sulfonylurinstof/ metformin henholdsvis 14, 5% og 30, 3%.
17 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
I en 24- ugers undersøgelse af den initiale kombinationsbehandling med sitagliptin og metformin to gange dagligt (sitagliptin/ metformin 50 mg/ 500 mg eller 50 mg/ 1. 000 mg) var den totale bivirkningsincidens, som blev anset for at være lægemiddelrelateret, henholdsvis 14, 0% og 9, 7% hos 18 de patienter, der blev behandlet med kombinationen af sitagliptin og metformin sammenlignet med de patienter, der fik placebo.
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
Efter markedsføring:
18 Post-marketing Experience:
Behandling med GLP- 1 eller DPP- 4 hæmmere i dyremodeller af type 2 - diabetes har vist sig at forbedre betacellernes reaktion på glucose og at stimulere syntesen samt frigivelsen af insulin.
Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
Målt som klinisk relevante reduktioner i HbA1c i forhold til baseline ved study endpoint (se Tabel 2) forbedrer sitagliptin totalt set den glykæmiske kontrol, når det gives som monoterapi, i kombination med metformin (initialt eller som tillægsterapi), i kombination med sulfonylurinstof (med eller uden metformin) og i kombination med et glitazon.
19 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
Sammenlignet med placebo gav behandling med sitagliptin 100 mg én gang dagligt som monoterapi signifikante forbedringer i HbA1c i faste- plasmaglucose (FPG) og 2- timers postprandial glucose (2 - timers PPG), når det blev sammenlignet med placebo i to undersøgelser, hvor den ene var af 18 ugers varighed og den anden af 24 ugers varighed.
Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
Gennemsnitlig baseline HbA1c (%)
change in HbA1c (%) at
Gennemsnitlig ændring fra baseline HbA1c (%) i 24. uge †
baseline HbA1c (%)
Placebokontrolleret gennemsnitlig ændring (%) i 24. uge † (95% CI)
Week 24†
Monoterapiundersøgelser Sitagliptin 100 mg én gang dagligt§
Monotherapy Studies
- 0, 5
at Week 24†
- 0, 6 ‡
(95% CI)
(N=193) Sitagliptin 100 mg én gang dagligt (N=229) Kombinationsterapiundersøgelser Sitagliptin 100 mg én gang dagligt
Sitagliptin 100 mg once daily§ (N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies Sitagliptin 100 mg once daily added to
- 0, 6
-0.5 -0.6
(- 0, 8; - 0, 4) - 0, 8 ‡ (- 1, 0; - 0, 6) - 0, 7 ‡
-0.6‡ (-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
(- 0, 8; - 0, 5) - 0, 7 ‡
HbA1c (%)
21 for effektiviteten af insulinsyntese og - sekretion, med sitagliptin og forværredes med glipizidbehandling.
In this study, the proinsulin to insulin ratio, a marker of efficiency of insulin synthesis and release, improved with sitagliptin and deteriorated with glipizide treatment.
22 Nyreinsufficiens I en åben undersøgelse med enkeltdosis blev farmakokinetikken for en reduceret dosis sitagliptin (50 mg) vurderet hos patienter med varierende grader af kronisk nyreinsufficiens sammenlignet med normale raske kontrolpersoner.
Renal insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50-mg) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
23 vist sig at korrelere med induktion af hepatisk neoplasi hos rotter, var denne øgede forekomst af hepatiske tumorer sandsynligvis sekundær til kronisk hepatisk toksicitet ved denne høje dosis.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Tabletkerne Mikrokrystallinsk cellulose (E460) Calciumhydrogenphosphat, vandfrit (E341) Croscarmellosenatrium (E468) Magnesiumstearat (E470b) Natriumstearylfumarat
23 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
24 6. 6 Særlige forholdsregler ved bortskaffelse
6.6 Special precautions for disposal
26 Patienter med nyreinsufficiens Til patienter med mild nyreinsufficiens (kreatinin- clearance [CrCl] ≥50 ml/ min, er dosisjustering for TESAVEL ikke nødvendig.
26 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
27 4. 5 Interaktion med andre lægemidler og andre former for interaktion
27 Metformin:
28 Amning Det vides ikke, om sitagliptin udskilles i modermælk hos mennesker.
Lactation It is unknown whether sitagliptin is excreted in human breast milk.
4. 8 Bivirkninger
28 4.8 Undesirable effects
sulfonylurinstof3
Metabolism and nutrition disorders
Perifert ødem Undersøgelser
General disorders peripheral oedema
1 I denne placebo- kontrollerede 24- ugers undersøgelse af sitagliptin 100 mg én gang dagligt i kombination med metformin var incidensen af formodede bivirkninger 9, 3% hos de patienter, der blev behandlet med sitagliptin/ metformin sammenlignet med 10, 1% hos de patienter, der fik placebo/ metformin.
1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to treatment with placebo/ metformin was 9.3% and 10.1%, respectively.
I en supplerende 1- års undersøgelse af sitagliptin 100 mg én gang dagligt i kombination med metformin var incidensen af formodede bivirkninger hos de patienter, der blev behandlet med sitagliptin/ metformin sammenlignet med de patienter, der fik et sulfonylurinstof/ metformin henholdsvis 14, 5% og 30, 3%.
29 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
I en 24- ugers undersøgelse af den initiale kombinationsbehandling med sitagliptin og metformin to gange dagligt (sitagliptin/ metformin 50 mg/ 500 mg eller 50 mg/ 1. 000 mg) var den totale bivirkningsincidens, som blev anset for at være lægemiddelrelateret, henholdsvis 14, 0% og 9, 7% hos 30 de patienter, der blev behandlet med kombinationen af sitagliptin og metformin sammenlignet med de patienter, der fik placebo.
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
Efter markedsføring:
30 Post-marketing Experience:
4. 4).
During post-marketing experience the following additional side effects have been reported (frequency not known): hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
TESAVEL tilhører en klasse af orale anti- hyperglykæmiske lægemidler, der kaldes dipeptidylpeptidase - hæmmere.
TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Målt som klinisk relevante reduktioner i HbA1c i forhold til baseline ved study endpoint (se Tabel 2) forbedrer sitagliptin totalt set den glykæmiske kontrol, når det gives som monoterapi, i kombination med metformin (initialt eller som tillægsterapi), i kombination med sulfonylurinstof (med eller uden metformin) og i kombination med et glitazon.
31 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
Sammenlignet med placebo gav behandling med sitagliptin 100 mg én gang dagligt som monoterapi signifikante forbedringer i HbA1c i faste- plasmaglucose, (FPG) og 2- timers postprandial glucose (2 - timers PPG), når det blev sammenlignet med placebo i to undersøgelser, hvor den ene var af 18 ugers varighed og den anden af 24 ugers varighed.
Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
I en undersøgelseaf effekt og sikkerhed af tillægsbehandling med TESAVEL 100 mg én gang dagligt eller glipizid (et sulfonylurinstof) til patienter med utilstrækkelig glykæmisk kontrol på metforminmonoterapi, var sitagliptin sammenlignelig med glipizid mht. reduktion af HbA1c.
In a study comparing the efficacy and safety of the addition of TESAVEL 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
33 for effektiviteten af insulinsyntese og - sekretion, med sitagliptin og forværredes med glipizidbehandling.
In this study, the proinsulin to insulin ratio, a marker of efficiency of insulin synthesis and release, improved with sitagliptin and deteriorated with glipizide treatment.
34 Nyreinsufficiens I en åben undersøgelse med enkeltdosis blev farmakokinetikken for en reduceret dosis sitagliptin (50 mg) vurderet hos patienter med varierende grader af kronisk nyreinsufficiens sammenlignet med normale raske kontrolpersoner.
Renal insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50-mg) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Undersøgelsen omfattede patienter med nyreinsufficiens klassificeret på basis af kreatinin- clearance som mild (50 til < 80 ml/ min), moderat (30 til < 50 ml/ min) og svær (< 30 ml/ min) samt patienter med ESRD i hæmodiayse.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to < 80 ml/ min), moderate (30 to < 50 ml/ min), and severe (< 30 ml/ min), as well as patients with end-stage renal disease (ESRD) on hemodialysis.
35 vist sig at korrelere med induktion af hepatisk neoplasi hos rotter, var denne øgede forekomst af hepatiske tumorer sandsynligvis sekundær til kronisk hepatisk toksicitet ved denne høje dosis.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Tabletkerne Mikrokrystallinsk cellulose (E460) Calciumhydrogenphosphat, vandfrit (E341) Croscarmellosenatrium (E468) Magnesiumstearat (E470b) Natriumstearylfumarat
35 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
36 6. 6 Særlige forholdsregler ved bortskaffelse
6.6 Special precautions for disposal
Pharmacovigilance- systemet Indehaveren af markedsføringstilladelsen skal sikre, at systemet for pharmacovigilance, som beskrevet i version 2 i Modul 1. 8. 2 i ansøgningen om markedsføringstilladelse, er på plads og i funktion, før produktet kommer på markedet og efter markedsføring.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application and any subsequent updates, is in place and functioning before and whilst the product is on the market.
Risk Management Plan Indehaveren af markedsføringstilladelsen forpligter sig til at udføre undersøgelser og supplerende pharmacovigilance- aktiviteter som beskrevet i pharmacovigilance- planen, og som det fremgår af version 1. 1 af Risk Management Planen (RMP), der er beskrevet i Modul 1. 8. 2 i ansøgningen om markedsføringstilladelse og alle efterfølgende opdateringer af RMP, som er vedtaget 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 1.1 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.
I henhold til CHMP Guideline for Risk Management Systemer for lægemidler til human brug skal den opdaterede RMP indsendes samtidigt med den næste Periodic Safety Update Report (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).