natgillin/translations-raw huggingface dataset:
Ansøgeren forpligter sig til at fremsende følgende oplysninger til den nationale kompetente myndighed for referencemedlemsstaten:
The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State:
Analyse af 30% - og 50% - responsraterne efter 10 og 15 minutter for forsøg EN- 3267- 005
Analysis of the 30% and 50% responder rates at 10 and 15 minutes for the study EN-3267- 005,
Endelige resultater af forsøg EN3267- 005 og 3267- 007, herunder detaljerede data om eksponering hos patienter samt en komplet sikkerhedsanalyse.
Final results of studies EN3267-005 and 3267-007, including detailed exposure of patients and full safety analysis.
London, den 12. september 2008 EMEA/ CHMP/ 495838/ 2008
London, 12 September 2008 EMEA/ CHMP/ 495857/ 2008
UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK.
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
41, OM Rapinyl og tilknyttede navne
Rapinyl and associated names
Den decentrale procedure, SE/ H/ 575/ 07/ DC, indledtes den 1. september 2006.
The Decentralised Procedure, SE/ H/ 575/ 07/ DC, started on 1 September 2006.
Der er konstateret en signifikant meningsforskel for så vidt angår behovet for yderligere oplysninger vedrørende den kliniske virkning og sikkerhed til belysning af benefit/ risk- forholdet og manglen på farmakokinetiske data under normal brug af produktet.
Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/ risk and the lack of PK data under normal conditions of use of the product.
Pierre Demolis (F).
The Rapporteur was Dr Tomas Salmonson (SE) and Dr Pierre Demolis (FR) was Co-Rapporteur.
Efter gennemgang af alle fremlagte oplysninger og den faglige drøftelse i udvalget vurderede CHMP på sit møde i juni 2008, at benefit/ risk- forholdet for Rapinyl og tilknyttede navne er positivt, at de indvendinger, som Tyskland, Frankrig, Norge og Det Forenede Kongerige havde rejst, ikke skulle stå i vejen for udstedelse af en markedsføringstilladelse, og at produktresuméet, etiketteringen og indlægssedlen i referencemedlemsstaten skulle ændres.
During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
Udvalget vedtog ved konsensus en positiv udtalelse den 26. juni 2008.
A positive opinion was adopted by consensus on 26 June 2008
Listen over de pågældende produktnavne fremgår af bilag I.
The list of the product names concerned is given in Annex I.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
1 Medlemslande
1 Member State
Indehaver af markedsføringstilladelsen
Marketing Authorisation INN Holder
Navneforslag
Invented Name
Farmaceutisk Form
Pharmaceutical Form
Administrations - vej
Route of administration
Smeltetabletter
Orodispersible tablets
15 mg
15 mg 30 mg 45 mg 15 mg 30 mg
Filmovertrukne tabletter
Film-coated tablets Film-coated tablets Film-coated tablets Orodispersible tablets Orodispersible tablets
5349AB Oss, The Netherlands
Organon België n. v.,
30 mg
45 mg
Filmovertrukne tabletter
Orodispersible tablets
Delegation of power:
Terhulpsesteenweg 166, 1170 Brussels, Belgium
Remergon
Remergon
Oral opløsning
Oral use
Oral anvendelse 990 mg/ 66 ml
990 mg/ 66 ml
REMERON 45 MG
REMERON 15 MG REMERON 30 MG REMERON 45 MG REMERON SOLTAB 15 MG
Filmovertrukne tabletter
Film-coated tablets Film-coated tablets Film-coated tablets Orodispersible tablets
2 Medlemslande
2 Member State
IMI Pharma AS, Literbuen 9, DK - 2740 Skovlunde, Denmark
IMI Pharma AS, Literbuen 9, DK- 2740 Skovlunde, Denmark
Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Mirtazapine Mirtazapine
Mitazon Smelt Mitazon Smelt Mitazon Smelt
Mitazon Smelt Mitazon Smelt Mitazon Smelt
15 mg 30 mg 45 mg
15 mg 30 mg 45 mg
Smeltetabletter Smeltetabletter Smeltetabletter
Orodispersible tablets Orodispersible tablets Orodispersible tablets
Box 20, 5340 BH Oss,
Box 20, 5340 BH Oss,
Remeron Smelt Remeron Smelt Remeron Smelt
Remeron Smelt Remeron Smelt Remeron Smelt
Filmovertrukne tabletter
Film-coated tablets Film-coated tablets Film-coated tablets
Mirtazapine Remeron SolTab Mirtazapine Remeron SolTab Mirtazapine Remeron SolTab
Remeron SolTab Remeron SolTab
15 mg 30 mg 45 mg
30 mg 45 mg
Smeltetabletter Smeltetabletter Smeltetabletter
Orodispersible tablets Orodispersible tablets
Mirtazapine Remeron Soltab Mirtazapine Remeron Soltab Mirtazapine Remeron Soltab
Remeron Soltab Remeron Soltab Remeron Soltab
Indhold (koncentration)
Mirtazapine Mirtazapine
Filmovertrukne tabletter
Film-coated tablets Film-coated tablets
Filmovertrukne tabletter
Oral Solution Film-coated tablets
Oral anvendelse
Content (concentration)
00240 Helsinki, Finland
Maistraatinportti 2 00240 Helsinki, Finland
Mirtazapine Mirtazon Smelt Mirtazapine Mirtazon Smelt Mirtazapine Mirtazon Smelt
Mirtazon Smelt Mirtazon Smelt Mirtazon Smelt
15 mg
15 mg 30 mg 15 mg
Filmovertrukne tabletter
Film-coated tablets Film-coated tablets Orodispersible tablets
10 rue Godefroy 92821 PUTEAUX Cedex
Mirtazapine
France
Norset
Mirtazapine Norset Mirtazapine Norset Mirtazapine Norset Mirtazapine Norset
Mirtazapine
15 mg 30 mg 45 mg 15 mg/ ml
15 mg/ ml
Smeltetabletter Smeltetabletter Smeltetabletter Oral opløsning
Oral solution
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse 990 mg/ 66 ml
990 mg/ 66 ml
Mirtazapine Remergil
Mirtazapine
Grækenland
4 Member State
122, Vouliagmenis Av.
Marketing Authorisation INN Holder
Mirtazapine
Invented Name
Remeron
Strength
15 mg
Pharmaceutical Form
Remeron
Remeron SolTab
Mirtazapine Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Mirtazapine Mirtazapine
Remeron SolTab Remeron SolTab Remeron SolTab Remeron
Remeron SolTab Remeron SolTab Remeron
15 mg 30 mg 45 mg 15 mg/ ml
30 mg 45 mg 15 mg
Smeltetabletter Smeltetabletter Smeltetabletter Oral opløsning
Orodispersible tablets Orodispersible tablets Oral Solution
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse 990 mg/ 66 ml
Oral use Oral use Oral use
Mirtazapine Remeron SolTab Mirtazapine Remeron SolTab
Remeron SolTab
30 mg 45 mg
45 mg
Smeltetabletter Smeltetabletter
Orodispersible tablets
Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Mirtazapine
Remeron Smelt Remeron Smelt Remeron Smelt
Remeron Remeron
Mirtazapine
Mirtazapine Organon Laboratories Ltd, Mirtazapine Cambridge Science Park,
Oral opløsning
Oral Solution Film-coated tablets
Organon Laboratories Ltd, Cambridge Science Park, Milton Road, CB4 0FL,
Milton Road, CB4 0FL, Mirtazapine United Kingdom
Zispin® Filmovertrukne tabletter
Zispin® tablets
Filmovertrukne Oral anvendelse tabletter
Film-coated tablets
Mirtazapine
Organon (Ireland) Limited, Mirtazapine
Zispin® Filmovertrukne tabletter
Zispin®
Filmovertrukne Oral anvendelse tabletter
Oral use
Organon (Ireland) Limited, PO Box 2857,
PO Box 2857,
Mirtazapine
5 Member State
Zispin® Soltab® smeltetabletter
Marketing Authorisation INN Holder
Smeltetabletter
Pharmaceutical Form
Drynam Road, Swords, Co.
Drynam Road, Swords, Co.
Dublin,
Dublin,
Zispin® Soltab® smeltetabletter
Zispin® Soltab® orodispersible tablets
Zispin® Oral opløsning
Zispin® oral solution
mirtazapine Remeron
mirtazapine Mirtazapine
Filmovertrukne tabletter
Oral solution
Oral anvendelse 990 mg/ 66 ml Oral anvendelse Oral anvendelse
990 mg/ 66 ml
Mirtazapine Mirtazapine
Mirtazapine Mirtazapine Mirtazapine Mirtazapine Mirtazapine Mirtazapine
Remeron Mirtazapina Organon
Remeron Remeron Remeron Mirtazapina Organon Mirtazapina Organon Mirtazapina Organon
45 mg 15 mg
15 mg 30 mg 45 mg 15 mg 30 mg 45 mg
Smeltetabletter Smeltetabletter
Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets
Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use
30 mg
30 mg 15 mg 30 mg
Smeltetabletter
Film-coated tablets Orodispersible tablets Orodispersible tablets
Filmovertrukne
Film-coated tablets
Mirtazapine Remeron SolTab Mirtazapine Remeron SolTab Mirtazapine Remeron SolTab
Mirtazapine
15 mg 30 mg 45 mg
15 mg
Smeltetabletter Smeltetabletter Smeltetabletter
Orodispersible tablets
Oral anvendelse Oral anvendelse Oral anvendelse
Oral use
Litauen
The Netherlands
N. V.
Mirtazapine
Mirtazapine Remeron
Remeron Sol Tab
Filmovertrukne Oral anvendelse tabletter
Orodispersible tablets
20, 5340 BH Oss,
Oral use
15 mg
45 mg
Smeltetabletter Oral anvendelse
Orodispersible tablets
The Netherlands
Oral use
Mirtazapine Remeron Sol Tab
6 Member State
Smeltetabletter Oral anvendelse
Marketing Authorisation INN Holder
Mirtazapine Remeron Sol Tab
Invented Name
5349AB Oss, The Netherlands
The Netherlands Delegation of power:
Mirtazapine Remergon
Mirtazapine Mirtazapine
Filmovertrukne tabletter
Orodispersible tablets Orodispersible tablets
Delegation of power:
Organon België n. v.,
Organon België n. v., Terhulpsesteenweg 166, 1170 Brussels, Belgium
Terhulpsesteenweg 166, 1170 Brussels, Belgium
15 mg 30 mg 45 mg
Mirtazapine
Navneforslag
Netherlands
Mirtazapine Mirtazapine Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Mirtazapine Mirtazapine Mirtazapine
Remeron drank Remeron SolTab Remeron SolTab Remeron SolTab Mirtazapine orodispr. geerbare tabletten
Remeron SolTab Remeron SolTab Remeron SolTab Mirtazapine orodispergeerbare tabletten
15 mg/ ml 15 mg 30 mg 45 mg 15 mg
15 mg 30 mg 45 mg 15 mg
Oral opløsning Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter
Orodispersible Tablets Orodispersible Tablets Orodispersible Tablets Orodispersible Tablets
Oral anvendelse 990 mg/ 66 ml Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use
Mirtazapine orodispr. geerbare tabletten
Mirtazapine orodispergeerbare tabletten
Smeltetabletter
Orodispersible Tablets
Organon,
Box 20, 5340 BH Oss,
Filmovertrukne Oral anvendelse
Oral use Oral use Oral use
Kloosterstraat 6, P. O.
30 mg per tablet 45 mg per tablet 15 mg per tablet
Box
7
tabletter
Member State
20, 5340 BH Oss,
Marketing Authorisation INN Holder
45 mg
Pharmaceutical Form
Filmovertrukne Oral anvendelse tabletter
Content (concentration)
Smeltetabletter Oral anvendelse
Oral use
Remeron- S smeltetabletter
Remeron mikstur, oppløsning
Smeltetabletter Oral anvendelse
Oral solution
15 mg/ ml
Oral use
Oral opløsning Oral anvendelse 990 mg/ 66 ml
990 mg/ 66 ml
15 mg
30 mg per tablet
Filmovertrukne Oral anvendelse tabletter
Portugal
Mirtazapine Mirtazapina Organon
Mirtazapine Mirtazapine Mirtazapine
Filmovertrukne Oral anvendelse tabletter
Film-coated tablets Film-coated tablets Film-coated tablets
Mirtazapine Remeron SolTab Mirtazapine Remeron SolTab Mirtazapine Remeron SolTab Mirtazapine Remeron
Remeron SolTab Remeron SolTab Remeron
15 mg 30 mg 45 mg 15 mg/ ml
30 mg 45 mg 15 mg/ ml
Smeltetabletter Oral anvendelse Smeltetabletter Oral anvendelse Smeltetabletter Oral anvendelse Oral opløsning Oral anvendelse
Orodispersible tablets Orodispersible tablets Oral solution
Aacifar Produtos Químicos e Farmacêuticos, Lda Av.
Aacifar Produtos Químicos e Farmacêuticos, Lda Av.
José Malhoa, 16- B - 2º 1070- 159 Lisboa Portugal
José Malhoa, 16-B -2º 1070-159 Lisboa Portugal
Mirtazapine Mirtazon Mirtazapine Mirtazon Mirtazapine Mirtazon
Mirtazapine Mirtazapine Mirtazapine
Smeltetabletter Oral anvendelse Smeltetabletter Oral anvendelse Smeltetabletter Oral anvendelse
Oral use Oral use Oral use
Remeron SolTab 15 mg
Remeron SolTab 15 15 mg mg
Remeron SolTab 30 mg
Remeron SolTab 30 30 mg mg
The Netherlands
8 Member State
Mirtazapine
Marketing Authorisation INN Holder
Remeron SolTab 45 mg
Invented Name
Slovakiet
Content (concentration)
Organon,
The Netherlands
15 mg 15 mg
Remeron mg
9 Medlemslande
SolTab 45
INN
45 mg
Navneforslag
Orodispersible tablets
Farmaceutisk Form
Slovak Republic
Administrations - vej
N. V.
45 mg
REMERON 15 mg
REMERON 30 mg
REMERON 30 mg
Soltab
Soltab
REMERON 45 mg
REMERON 45 mg
Rexer
Rexer Rexer Rexer
Filmovertrukne Oral anvendelse tabletter
Oral use Oral use Oral use
Rexer
Rexer Flas
Spain
Llobregat Barcelona, Spain N. V.
Mirtazapine Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Mirtazapine Mirtazapine Mirtazapine Mirtazapine Mirtazapine
Rexer Flas Rexer Flas Rexer Flas Rexer
Rexer Flas Rexer Flas Rexer Mirtazapina Organon Mirtazapina Organon Mirtazapina Organon
15 mg 30 mg 45 mg 15 mg/ ml
30 mg 45 mg 15 mg/ ml 15 mg 30 mg 45 mg
Smeltetabletter Smeltetabletter Smeltetabletter Oral opløsning
Orodispersible tablets Orodispersible tablets Oral solution Orodispersible tablets Orodispersible tablets Orodispersible tablets
Mirtazapina Organon
Remeron Remeron Remeron
Smeltetabletter
Tablets Tablets Tablets
Mirtazapina Organon
Remeron Remeron-S
45 mg
15 mg/ ml 15 mg
Smeltetabletter
Oral solution Orodispersible tablets
20, 5340 BH Oss,
990 mg/ 66 ml
10 Medlemslande
9 Member State
Mirtazapine Mirtazapine Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Mirtazapine Mirtazapine
Remeron Remeron- S Remeron- S Remeron- S Mirtazapin IP
Remeron-S Remeron-S Mirtazapin Imi Pharma
15 mg/ ml 15 mg 30 mg 45 mg 15 mg
30 mg 45 mg 15 mg
Oral opløsning Smeltetabletter Smeltetabletter Smeltetabletter Filmovertrukne tabletter
Orodispersible tablets Orodispersible tablets Tablets
Oral anvendelse 990 mg/ 66 ml Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use
Filmovertrukne tabletter
Tablets
Mirtazapine 15mg/ ml Oral opløsning
Mirtazapine 15mg/ ml Oral Solution
Zispin SolTab 15mg orodispr. sible tablet
Zispin SolTab 15mg orodispersible tablet
Zispin SolTab 30mg orodispr. sible tablet
Zispin SolTab 30mg orodispersible tablet
Zispin SolTab 45mg orodispr. sible tablet
Zispin SolTab 45mg orodispersible tablet
12 BILAG II
10 ANNEX II
13 FAGLIGE KONKLUSIONER
11 SCIENTIFIC CONCLUSIONS
1, i direktiv 2001/ 83/ EF blev der indbragt en sag med henblik på harmonisering af produktresuméet for Remeron (mirtazapin).
Remeron (mirtazapine) has been referred for the harmonisation of Summary of Product Characteristics, in accordance with Article 30 (1) of Directive 2001/ 83/ EC.
Indbringelsen blev foranlediget af ansøgeren og har til formål at harmonisere større uoverensstemmende områder mellem EU’ s medlemsstater med hensyn til produktresuméer, indlægssedler, etikettering og afsnit 3 for følgende produkter, der indeholder det aktive stof mirtazapin:
The referral was triggered by the applicant and aims to harmonise major areas of discrepancy between the EU member states, with regard to the Summary of Product Characteristics (SPCs), Package Leaflets (PLs), labelling and Module 3 of the following products containing the active substance mirtazapine:
Remeron, tabletter, 15, 30 og 45 mg Remeron, smeltetabletter, 15, 30 og 45 mg Remeron, oral opløsning, 15 mg/ ml
Remeron tablets 15, 30 and 45 mg Remeron orodispersible tablets 15, 30 and 45 mg Remeron oral solution 15 mg/ ml
Den 14. februar 2007 vedtoges en kombineret fornyelse, via den gensidige anerkendelsesprocedure, for Remeron filmovertrukne tabletter, 45 mg, Remeron, 15, 30, 45 mg, Remeron oral opløsning 15 mg/ ml, Mirtazapin smeltetabletter, 15, 30, 45 mg, som omfattede i alt otte medlemsstater, herunder referencemedlemsstaten (RMS).
On 14 February 2007 a combined renewal via MRP was concluded for Remeron film-coated tablets 45 mg, Remeron 15, 30, 45 mg, Remeron oral solution 15 mg/ ml, Mirtazapine orodispersible tablets 15, 30, 45 mg., involving in total 8 Member States, including the Reference Member State (RMS).
Endelig blev de indbragte produktresuméer revideret i henhold til Europa- Kommissionens retningslinje vedrørende produktresuméer fra oktober 2005.
Finally, the referral SPCs were revised in accordance with the European Commission (EC) Guideline on SPC, October 2005.
Produktresumé, afsnit 4. 1 Terapeutiske indikationer
SPC Section 4.1 Therapeutic Indications
I afsnit 4. 1, Terapeutiske indikationer, i produktresuméet vurderede CHMP, at indikationen skulle ændres til:
In section 4.1 Therapeutic Indications of the SPC, the CHMP considered that the indication should be amended to:
Svære depressive episoder (eller behandling af svære depressive episoder) i henhold til den vedtagne formulering for denne indikation for andre produkter, som produktresuméet er harmoniseret for i Europa.
Episodes of major depression (or treatment of episodes of major depression) in accordance with the wording agreed for this indication for other products of which the SPC is harmonised in Europe.
CHMP vurderede, at tilføjelsen af "hos voksne" ikke var acceptabel.
The CHMP considered that the addition of “ in adults” was not acceptable.
Dette forslag blev godkendt af ansøgeren/ indehaveren af markedsføringstilladelsen, og problemet blev løst.
This proposal was adopted by the applicant/ MAH and the issue was resolved.
Produktresumé, afsnit 4. 2 Dosering og indgivelsesmåde
SPC Section 4.2 Posology and Method of Administration
(i henhold til formuleringen for andre antidepressiva).
In Section 4.2 Posology and method of administration of the SPC, the CHMP considered that the sentence “ Treatment should preferably be continued until the patient has been completely symptom- free for 4-6 months” should be replaced by “ Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms .” (in accordance with the wording of other antidepressants).
Forslaget blev godkendt af ansøgeren/ indehaveren af markedsføringstilladelsen, og spørgsmålet blev således afklaret.
The proposal was adopted by the applicant/ MAH and the issue was resolved.
CHMP vurderede desuden, at udskillelsen af mirtazapin kan reduceres hos patienter med moderat til svær nyrebeskadigelse (kreatinin- udskillelse < 40 ml/ min.).
Additionally, the CHMP considered that the clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/ min).
Der skal tages højde for dette, når Remeron ordineres til denne gruppe patienter (se afsnit 4. 4).
This should be taken into account when prescribing Remeron to this category of patients (see section 4.4).
(moderat nyrebeskadigelse).
The applicant/ MAH was therefore asked to provide support for the cut-off at 40 ml/ min as the range is normally defined as 30- 50 ml/ min (moderate renal impairment).
For at undersøge virkningen af nyrebeskadigelse på farmakokinetikken for mirtazapin henviser ansøgeren/ indehaveren af markedsføringstilladelsen til en klinisk undersøgelse, som blev udformet specifikt til dette formål (undersøgelse 22503).
To investigate the impact of renal impairment on the pharmacokinetics of mirtazapine, the applicant/ MAH made reference to a clinical trial that was designed specifically for that purpose (trial 22503).
I denne undersøgelse blev forsøgspersonerne inddelt i fire kategorier med følgende grænseværdier:
In this study, subjects were divided into 4 categories using the following cut-off values:
Gruppe 1 Normalt sunde kontrolpersoner med en glomerulær filtrationshastighed på > 80 ml/ min. / 1, 73 m2 Gruppe 2 Mild nyreinsufficiens med en glomerulær filtrationshastighed på 40- 79 ml/ min. / 1, 73 m2
Group 1 Normal healthy controls with a glomerular filtration rate (GFR) of > 80 ml/ min/ 1.73 m2 Group 2 Mild renal insufficiency with a GFR of 40-79 ml/ min/ 1.73 m2 Group 3 Moderate/ marked renal insufficiency with a GFR 10-39 ml/ min/ 1.73 m2 Group 4 Severe renal insufficiency with a GFR < 10 ml/ min/ 1.73 m2 In each subgroup 10 subjects were included.
På dette tidspunkt, i 1989, var grænseværdierne for niveauet af nyrebeskadigelse på linje med udkastet til FDA’ s branchevejledning for farmakokinetik og farmakodynamik hos patienter med nedsat nyrefunktion: undersøgelsesopbygning, dataanalyse og indvirkning på dosering och etikettering.
12 At that time, in 1989, the cut-off values for the level of renal impairment were in line with FDA draft Guidance for Industry on “ Pharmacokinetics and Pharmacodynamics in patients with Impaired renal function: study design, data analysis, and impact on dosing and labelling”.
Dette er årsagen til grænseværdien på 40 ml/ min. / 1, 73 m2.
That is the reason for the cut-off value of 40 ml/ min/ 1.73 m2.
Denne FDA- vejledning blev erstattet i 1998.
This FDA Guidance was superseded in 1998.
Desuden blev den seneste EU- vejledning for vurdering af farmakokinetikken for lægemidler hos patienter med nedsat nyrefunktion først fastlagt i 1994 (Note for Guidance on the evaluation on the pharmacokinetics of medicinal products in patients with impaired renal function, CHMP/ EWP/ 225/ 02).
In addition, the most recent EU Guideline was only established in 1994 (Note for Guidance on the evaluation on the pharmacokinetics of medicinal products in patients with impaired renal function, CHMP/ EWP/ 225/ 02).
Produktresumé, afsnit 4. 3 Kontraindikationer
SPC Section 4.3 Contraindications
Ansøgeren/ indehaveren af markedsføringstilladelsen begrænsede kontraindikationen til overfølsomhed i henhold til EU- vejledningen vedrørende produktresuméer, da kun absolutte kontraindikationer skal nævnes, og relative kontraindikationer skal flyttes til advarselsafsnit 4. 4.
The applicant/ MAH restricted the contra-indication to hypersensitivity only, in accordance with the EC Guideline on SPC, as only absolute contraindications should be mentioned and relative contra- indications should move to the warning section 4.3 or section.
Men CHMP vurderede ikke denne forklaring til at være acceptabel og anmodede om, at ansøgeren/ indehaveren af markedsføringstilladelsen skal argumentere for, hvorfor disse kontraindikationer ikke er absolutte.
However, the CHMP did not consider this explanation acceptable and requested that the applicant/ MAH should argue why these contra- indications are not absolute.
CHMP var af den holdning, at fenylketonuri, MAO- inhibitorer og patologiske ændringer i blodtællingen anses for at være absolutte kontraindikationer.
The CHMP was of the opinion that Phenylketonuria, MAO inhibitors, and pathological alterations of blood count are considered absolute contra-indications.
Fenylketonuri Ansøgeren/ indehaveren af markedsføringstilladelsen argumenterede for inkluderingen af kontraindikationer, "som opstår ved tilstedeværelsen af visse hjælpestoffer (under henvisning til retningslinjen vedrørende hjælpestoffer på etiketten og indlægssedlen for humanmedicinske lægemidler)", i henhold til retningslinjen for produktresuméer (oktober 2005).
Phenylketonuria The applicant/ MAH argued that, according to the Guideline on SPC (October 2005) contraindications “ arising from the presence of certain excipients (under reference to the Guideline on excipients in the label and package leaflet of medicinal products for human use )” should be included.
Retningslinjen vedrørende hjælpestoffer i dokumentationen til en ansøgning om markedsføringstilladelse for et lægemiddel (EMEA/ CHMP/ QWP/ 396951/ 2006) samt ovennævnte retningslinje (CHMP/ 463/ 00) angiver, hvilke hjælpestoffer og oplysninger der skal fremgå af etiketteringen.
The Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product (EMEA/ CHMP/ QWP/ 396951/ 2006) and the above mentioned guideline (CHMP/ 463/ 00) indicate which excipients and information should appear in the labelling.
Bilaget angiver udtrykkeligt de hjælpestoffer, der skal nævnes som en kontraindikation (f. eks. overfølsomhed over for jordnødde - eller soyaolie).
The Annex explicitly mentions those excipients that require to be mentioned as a contraindication (e. g. hypersensitivity to peanut or soya oil).
Disse omfatter ikke arvelige stofskiftesygdomme på grund af aminosyremangel (fenylalanin), f. eks. fenylketonuri.
These do not include hereditary deficiencies of amino acid (phenylalanine) metabolism, such as phenylketonuria.