natgillin/translations-raw huggingface dataset:
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE, 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
Janssen- Cilag Pharma GmbH Pfarrgasse 75 A- 1232 Wien Østrig
Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria
Risperidon
Risperidon
Smeltetabletter
Orodispersible tablet Oral use
Filmovertrukne tabletter
Film-coated tablet Oral use
Oral
2
Lægemiddelform
Pharmaceutical Route of Form administration
3 mg -
3 mg - 3 mg
Pfarrgasse 75 A- 1232 Wien Østrig
Pfarrgasse 75 A-1232 Wien Austria
Risperdal 4 mg - Filmtabletten
Risperdal 4 mg - 4 mg Filmtabletten
Risperdal 6 mg - Filmtabletten
Risperdal 6 mg - 6 mg Filmtabletten
Risperdal 1 mg/ ml - 1 orale Lösung
Risperdal 1 mg/ ml - 1 mg orale Lösung
Rispolin Quicklet 0, 5 mg - Tabletten
Rispolin Quicklet 0,5 mg 0,5 mg - Tabletten
Rispolin Quicklet 1 mg - Tabletten
Rispolin Quicklet 1 1 mg mg - Tabletten
Rispolin Quicklet 2 mg - Tabletten
Rispolin Quicklet 2 2 mg mg - Tabletten
Rispolin Quicklet 3 mg - Tabletten
Rispolin Quicklet 3 3 mg mg - Tabletten
Rispolin 1 mg/ ml - orale Lösung
Rispolin 1 mg/ ml - 1 mg orale Lösung
Oral opløsning
Oral solution Oral use
Roderveldlaan 1 B- 2600 Berchem Belgien
Roderveldlaan 1 B-2600 Berchem Belgium
Roderveldlaan 1 B- 2600 Berchem, Belgien
Roderveldlaan 1 B-2600 Berchem, Belgium
Risperdal Instasolv
Risperdal Instasolv 0.5 mg
Risperdal Instasolv
Risperdal Instasolv 1 mg
Roderveldlaan 1 B- 2600
Roderveldlaan 1 B-2600
Oral
5
5 Medlemsstat
Member State
Berchem, Belgien
Berchem, Belgium
Smartinska cesta 53 1000 Ljubljana Slovenien
Smartinska cesta 53 1000 Ljubljana Slovenia
Filmovertrukne tabletter
Film coated tablet
Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340, Beerse, Belgien
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
J Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340, Beerse, Belgien
J Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Karla Engliše 3201/ 6 150 00 Praha 5 Tjekkiet
Karla Engliš e 3201/ 6 150 00 Praha 5 Czech Republic
Risperidon
Risperidonum
Oral
oral use
Karla Engliše 3201/ 6
Karla Engliš e 3201/ 6
Quicklet
Risperdal Quicklet 2 mg
Smeltetabletter
Orodispersible tablet oral use
Quicklet
Risperdal Quicklet 4 mg
Janssen- Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød Danmark
Janssen-Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød Denmark
Janssen- Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Danmark
Janssen-Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark
Filmovertrukne tabletter
Film-coated Oral use
Janssen- Cilag A/ S, Postboks 149, Hammerbakken 19, 3460
Janssen-Cilag A/ S, Postboks 149, Hammerbakken 19, 3460
Birkerød, Danmark
Birkerød, Denmark
Filmovertrukne tabletter
Film-coated
Smeltetabletter
Oral lyophilisate
Janssen- Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød
Janssen-Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød
1A LT- 09312 Vilnius Litauen
1A LT-09312 Vilnius Lithuania
Laboratorires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, Frankrig
Laboratorires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, France
Filmovertrukne tabletter
Scored tablet Oral use
Laboratoires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, Frankrig
Laboratoires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, France
0. 5 mg
Risperdal 0.5 mg
Film coatedtablet
Film coatedtablet Oral use
Laboratoires Janssen Cilag 1 rue Desmoulins
Laboratoires Janssen Cilag 1 rue Desmoulins
Filmovertrukne tabletter
Half-Scored tablet Oral use
Oral
12
12 Medlemsstat
Member State
TSA 91003 92787 Issy les Moulineaux Cedex 9, Frankrig
TSA 91003 92787 Issy les Moulineaux Cedex 9, France
Filmovertrukne tabletter
Half-Scored tablet
Filmtabletten 0, 25 mg
Risperdal Filmtabletten 0,25 mg
tabletter
Film-coated tablet
6 mg
mg
1 mg
mg
Janssen- Cilag GmbH 41457 Neuss or
Janssen-Cilag GmbH 41457 Neuss or
Risperdal Quicklet 1 mg
Risperdal Quicklet 1 mg 1 mg
Risperdal Quicklet 2 mg
Risperdal Quicklet 2 mg 2 mg
Risperdal Quicklet 3 mg
Risperdal Quicklet 3 mg 3 mg
Risperdal Quicklet 4 mg
Risperdal Quicklet 4 mg 4 mg
Risperidon- Janssen Filmtabletten 6 mg
Risperidon-Janssen 6 mg Filmtabletten 6 mg
Risperidon- Janssen Loesung 1 mg/ ml
Risperidon-Janssen 1 mg Loesung 1 mg/ ml
Oral
1 mg/ 1 ml
1 mg / 1 ml
16
16 Medlemsstat
Member State
Belivon 2 mg Filmtabletten
Belivon 2 mg Filmtabletten
Belivon 3 mg Filmtabletten
Belivon 3 mg Filmtabletten
Belivon
Belivon 4 mg Filmtabletten
6 mg
4 mg
Oral
Germany
Filmtabletten
Belivon 6 mg Filmtabletten
18
18 Member State
41470 Neuss, Tyskland
8 41470 Neuss, Germany
Janssen- Cilag GmbH 41457 Neuss or Janssen- Cilag GmbH Raiffeisenstr.
Janssen-Cilag GmbH
Rehablit Filmtabletten 6 mg
Rehablit
Rehablit Lösung 1 mg/ ml
Rehablit Lösung 1 1 mg mg/ ml
Janssen- Cilag Pharmaceutical S. A. C. I 56 Eirinis Avenue 56 Pefki, 15121 Grækenland
Janssen-Cilag Pharmaceutical S. A. C. I 56 Eirinis Avenue 56 Pefki, 15121 Greece
Janssen- Cilag Pharmaceutical S. A. C. I, 56 Eirinis Avenue, Pefki, 15121, Grækenland
Janssen-Cilag Pharmaceutical S. A. C. I, 56 Eirinis Avenue, Pefki, 15121, Greece
Risperdal
Risperdal 6 mg
Risperdal
Oral use
Pefki, 15121, Grækenland
Janssen-Cilag Pharmaceutical S. A. C. I, 56 Eirinis Avenue, Pefki, 15121, Greece
Risperdal Quicklet
Risperdal Quicklet 0.5 mg
Smeltetabletter
Lingual tablet
2045 Törökbálint Tó park Ungarn
2045 Törökbálint Tó park Hungary
2045 Törökbálint Tó park, Ungarn
2045 Törökbálint Tó park, Hungary
1mg
Risperdal 1mg
Janssen- Cilag AB Box 7073 192 07 Sollentuna Sverige
Janssen-Cilag AB Box 7073 192 07 Sollentuna Sverige
Smeltetabletter
Oral lyophilisate Oral use
Janssen- Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen-Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Filmovertrukne tabletter
Film coated tablet Oral use
1 mg
Iceland
Filmovertrukne tabletter
Risperidonum
Oral
Risperdal 2 mg
Filmovertrukne tabletter
Film Coated tablet Oral use
21 Medlemsstat
21
Janssen- Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Risperdal Liquid
Risperdal
1 mg
6 mg
Oral opløsning
Film Coated Tablet
6 mg
1 mg
Filmovertrukne tabletter
Film Coated Tablet
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ Storbritannien
Janssen-Cilag Ltd Saunderton High Wycombe
22
22 Member State
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ Storbritannien
Buckinghamshire HP14 4HJ United Kingdom
Janssen- Cilag Ltd
Janssen-Cilag Ltd
Saunderton High Wycombe Buckinghamshire HP14 4HJ Storbritannien
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Quicklet
Quicklet
23 Cologno Monzese 20093, Milano Italien
23 Cologno Monzese 20093, Milano Italy
0, 5 mg
Italy
Filmovertrukne tabletter
Janssen Cilag Spa Via Michelangelo Buonarroti n.
Oral
Tablet
Smeltetabletter
Orodispersible tablet Oral
Oral
25
25 Medlemsstat
Member State
23 Cologno Monzese 20093 Milano Italien
20093 Milano Italy
UAB Johnson & Johnson Šeimyniškių g. 1A LT- 09312 Vilnius Litauen
UAB Johnson & Johnson Š eimyniš kių g.1A LT-09312 Vilnius Lithuania
UAB Johnson & Johnson, Šeimyniškių g. 1A, LT- 09312 Vilnius, Litauen
UAB Johnson & Johnson, Š eimyniš kių g.1A, LT-09312 Vilnius, Lithuania
UAB Johnson & Johnson, Šeimyniškių g. 1A, Vilnius, Litauen
UAB Johnson & Johnson, Š eimyniš kių g.1A, Vilnius, Lithuania
Filmovertrukne tabletter
UAB Johnson & Johnson, Š eimyniš kių g.1A, LT-09312
Oral
1 mg
27
27 Member State
UAB Johnson & Johnson, Šeimyniškių g. 1A, LT- 09312 Vilnius, Litauen
Vilnius, Lithuania
Risperdal Quicklet
Risperdal Quicklet 1
Rispolept Quicklet
Rispolept Quicklet 1
Rispolept Quicklet
Rispolept Quicklet 2
2 mg
mg
Roderveldlaan 1 2600 Berchem Belgien
Roderveldlaan 1 2600 Berchem Belgium
Roderveldlaan 1 2600 Berchem, Belgien
Roderveldlaan 1 2600 Berchem, Belgium
Roderveldlaan 1 2600 Berchem,
Roderveldlaan 1 2600 Berchem,
29 Medlemsstat
29
Janssen- Cilag International NV Turnhoutseweg 30 2340 Beerse Belgien
Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium
Filmovertrukne tabletter
Tablets Oral use
Risperdal Quicklets
Risperdal Quicklets 0.5mg
Risperdal Quicklets
Risperdal Quicklets 1 mg
Risperdal Quicklets
Risperdal Quicklets 2 mg
Risperdal Risperdal omhulde tabletten 0, 5 mg
Risperdal 0.5 mg Risperdal omhulde tabletten 0,5 mg
Filmcoated talbets
Filmcoated talbets
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg
Risperdal Risperdal omhulde tabletten 1 mg
Risperdal Risperdal 1 mg omhulde tabletten 1 mg
Filmovertrukne tabletter
Filmcoated tablets
31 Medlemsstat
31
Risperdal Risperdal omhulde tabletten 2 mg
Risperdal Risperdal omhulde tabletten 2 mg
Risperdal Risperdal omhulde tabletten 3 mg
Risperdal Risperdal omhulde tabletten 3 mg
Risperdal Risperdal omhulde tabletten 4 mg
Risperdal Risperdal omhulde tabletten 4 mg
Risperdal Risperdal omhulde tabletten 6 mg
Risperdal Risperdal omhulde tabletten 6 mg
Risperdal Risperdal omhulde tabletten 8 mg
Risperdal Risperdal omhulde tabletten 8 mg
Belivon Belivon omhulde tabletten 1 mg
Belivon Belivon omhulde tabletten 1 mg
Belivon Belivon omhulde tabletten 2 mg
Belivon Belivon omhulde tabletten 2 mg
Belivon Belivon omhulde tabletten 3 mg
Belivon Belivon omhulde tabletten 3 mg
Risperdal Risperdal 1 1 mg mg/ ml, drank
Risperdal Risperdal 1 mg 1 mg/ ml, drank
Smeltetabletter
Orodisperable tablet
Paul Janssenweg 150 PO Box 90240
Paul Janssenweg 150 PO Box 90240
Risperdal Quicklet 3 mg Risperdal Quicklet 3 mg
Quicklet 3 mg Quicklet
Risperdal Quicklet 4 mg Risperdal Quicklet 4 mg
Quicklet 4 mg Quicklet
Belivon 2 mg
Belivon
Belivon 3 mg
Belivon
Janssen- Cilag AS Hoffsveien 1D
Janssen-Cilag AS Hoffsveien 1D
Belivon 4 mg
Belivon
0275 Oslo Norge
0275 Oslo Norway
Turnhauseveg 30 B- 2340 Beerse Belgien
Turnhauseveg 30 B-2340 Beerse Belgium
Rispolept Quicklet
Rispolept Quicklet 0,5 mg
Turnhauseveg 30
Turnhauseveg 30
36 Medlemsstat
36
B- 2340 Beerse Belgien
B-2340 Beerse Belgium Poland
Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734- 503 Barcarena Portugal
Turnhauseveg 30 B-2340 Beerse Belgium
Risperdal
Rispolept Quicklet 3 mg
Filmovertrukne tabletter
Orodispersible tablet Oral use
Janssen Farmacêutica Portugal, Lda.
Janssen-Cilag International N. V.
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734- 503 Barcarena Portugal
Turnhauseveg 30 B-2340 Beerse Belgium
Risperdal
Rispolept Quicklet 4 mg
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734- 503 Barcarena Portugal
Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Risperidon
Risperidona
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734- 503 Barcarena Portugal
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Oral opløsning
Film-coated tablet Oral use
Smeltetabletter
Film-coated tablet
Quicklet
Risperdal Quicklet 0.5 mg
Quicklet
Risperdal Quicklet 1 mg
Janssen Pharmaceutica N. V.
Janssen Farmacêutica Portugal, Lda.
Turnhoutseweg 30 2340 Beerse
Estrada Consiglieri Pedroso, 69
Rispolept
Risperdal Quicklet 3 mg
38 Medlemsstat
38
Belgien
A - Queluz de Baixo 2734-503 Barcarena Portugal
Janssen Pharmaceutica N. V.
Janssen Farmacêutica Portugal, Risperidona Lda.
Turnhoutseweg 30 2340 Beerse Belgien
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Risperidon
Risperdal
Rispolept
Quicklet 4 mg
Filmovertrukne tabletter
Orodispersible tablet
Risperidon
Risperidone Turnhoutseweg 30 2340 Beerse Belgium
3 mg
1 mg 1 mg
tabletter
Oral use
Turnhoutseweg 30, 2340 Beerse, Belgien
Risperidone Turnhoutseweg 30 2340 Beerse Belgium
4 mg
2 mg 2 mg
Turnhoutseweg 30, 2340 Beerse, Belgien
Risperidone Turnhoutseweg 30, 2340 Beerse, Belgium
1 mg
3 mg 3 mg
Oral opløsning
Film-coated tablets
Quicklet
4 mg 4 mg
Smeltetabletter
Film-coated tablets
Quicklet
1 mg
2 mg
Oral solution
Smeltetabletter
Oral use
Johnson & Johnson s. r. o.
Janssen Pharmaceutica N. V.
Risperidon
Risperidone Turnhoutseweg 30, 2340 Beerse, Belgium
Risperdal
Rispolept
1 mg
Quicklet 1 mg
Filmovertrukne tabletter
Dispersible tablets
2 mg
Quicklet 2 mg
Plynárenská 7/ B 824 78 Bratislava Slovakiet
Risperidone Plynárenská 7/ B 824 78 Bratislava
3 mg
1 mg
39 Medlemsstat
39
Plynárenská 7/ B 824 78 Bratislava Slovakiet
Plynárenská 7/ B 824 78 Bratislava Slovak Republic
4 mg
2 mg
Oral opløsning
Film coated tablet
Smeltetabletter
Film coated tablet
Johnson & Johnson d. o. o.
Johnson & Johnson s. r. o.
filmsko obložene tablete
Risperdal Quicklet 3 mg
tabletter
Orodispersible tablet Oral use
Johnson & Johnson d. o. o., Šmartinska 53, Ljubljana, Slovenien
Johnson & Johnson s. r. o.
Filmovertrukne tabletter
Plynárenská 7/ B 824 78 Bratislava
Risperdal 3 mg filmsko obložene
Risperdal Quicklet 4 mg
Johnson & Johnson d. o. o.,
Johnson & Johnson d. o. o.
4 mg 4 mg
1 mg 1 mg
Šmartinska 53, Ljubljana, Slovenien
Š martinska 53 Ljubljana Slovenia
Risperdal 1 mg/ ml peroralna raztopina
Risperdal Risperdal 2 mg filmsko oblož ene tablete
1 mg/ ml
2 mg
Risperdal Quicklet 0, 5 mg orodisperzibilna tableta
Risperdal 3 mg filmsko oblož ene tablete
0, 5 mg
3 mg
Risperdal Quicklet 1 mg orodisperzibilna tableta
Risperdal 4 mg filmsko oblož ene tablete
Risperdal Quicklet 2 mg orodisperzibilna tableta
Risperdal 1 mg/ ml peroralna raztopina
2 mg
1 mg/ ml
Smeltetabletter
Oral solution
Spanien
1 mg/ 1 ml
Janssen Cilag, SA Paseo de las Doce Estrellas 5- 7 28042 Madrid Spanien
Johnson & Johnson d. o. o., Š martinska 53, Ljubljana, Slovenia
Risperdal flas
Risperdal Quicklet 0,5 mg orodisperzibilna tableta
3 mg
0,5 mg
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 7 28042 Madrid, Spanien
Johnson & Johnson d. o. o., Š martinska 53, Ljubljana, Slovenia
Risperdal flas
Risperdal Quicklet 1 mg orodisperzibilna tableta
Risperdal flas
Risperdal Quicklet 2 mg orodisperzibilna tableta
0. 5 mg
2 mg
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 7 28042 Madrid, Spanien
Janssen Cilag, SA Paseo de las Doce Estrellas 5-7 28042 Madrid
Smeltetabletter
Orodispersable tablet
28042 Madrid, Spanien
Spain
Janssen Cilag, SA Paseo de las DoceEstrellas, 5- 7 28042 Madrid, Spanien
Janssen Cilag, SA Paseo de las Doce Estrellas, 5-7 28042 Madrid, Spain
Filmovertrukne tabletter
Orodispersable tablet
Janssen Cilag, SA Paseo de las Doce Estrellas, 5 - 728042 Madrid, Spanien
Janssen Cilag, SA Paseo de las Doce Estrellas, 5-7 28042 Madrid, Spain
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 7 28042 Madrid, Spanien
Janssen Cilag, SA Paseo de las Doce Estrellas, 5-7 28042 Madrid, Spain
Janssen Cilag, SA Paseo de las DoceEstrellas, 5- 7 28042 Madrid, Spanien
Janssen Cilag, SA Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain
Janssen Cilag, SA Paseo de las Doce Estrellas 5- 7 28042 Madrid Spanien
Janssen Cilag, SA Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain
Oral opløsning
Film coated tablets
Janssen- Cilag AB Box 7073 192 07 Sollentuna Sverige
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 728042 Madrid, Spain
Belivon
Risperdal
Janssen- Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen Cilag, SA Paseo de las Doce Estrellas, 5-7 28042 Madrid, Spain
Janssen- Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen Cilag, SA Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain
Janssen- Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen Cilag, SA Paseo de las Doce Estrellas 5-7 28042 Madrid Spain
Risperidon
Oral solution
Belivon
Oral use
6 mg
1 mg/ 1 ml
Janssen- Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen-Cilag AB Box 7073 192 07 Sollentuna
0. 5mg
2 mg
1mg
0.5mg
Oral opløsning
Risperidone
0, 5 mg
2 mg
3 mg
1mg
4 mg
0,5 mg
Saunderton High Wycombe Buckinghamshire HP14 4HJ Storbritannien
Janssen-Cilag AB, Box 7073 192 07 Sollentuna, Sverige
0. 25 mg
1 mg
Filmovertrukne tabletter
Oral lyophilisate
Saunderton High Wycombe
Janssen-Cilag AB, Box 7073 192 07 Sollentuna, Sverige
43
43 Member State
Buckinghamshire HP14 4HJ Storbritannien
Janssen-Cilag AB, Box 7073 192 07 Sollentuna, Sverige
1 mg
0.25 mg
Filmovertrukne tabletter
Coated Tablet
6 mg
3 mg
Saunderton High Wycombe Buckinghamshire HP14 4HJ Storbritannien
Saunderton High Wycombe Buckinghamshire HP14 4HJ
Oral opløsning
Coated Tablet
Risperdal Quicklet
Coated Tablet
0. 5 mg
Oral use
Smeltetabletter
Risperdal Liquid
Smeltetabletter
Orodispersible
45 BILAG II
45
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
46 FAGLIGE KONKLUSIONER
46 ANNEX II
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF RISPERDAL OG TILKNYTTEDE NAVNE (SE BILAG I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RISPERDAL AND ASSOCIATED NAMES (SEE ANNEX I)
Risperdal (risperidon) er et benzisoxazolderivativ med stærke kombinerede serotonin 5HT2A og dopamin D2 receptor- blokerende egenskaber.
Risperdal (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties.
Adrenerge α1 og i mindre omfang histamin H1 og adrenerge α2 receptorer modvirkes også af risperidon.
Adrenergic α 1 and, to a lesser extent, histamine H1 and adrenergic α 2 receptors are also antagonised by risperidone.
Godkendte formuleringer af oralt risperidon omfatter orale filmovertrukne tabletter, smeltetabletter og en oral opløsning.
Authorised formulations of oral risperidone include oral film-coated tablets, orodispersible tablets and an oral solution.
Proceduren for indbragte sager i henhold artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer, for Risperdal blev indledt for at løse uoverensstemmelser mellem de nationalt godkendte produktresuméer inden for EU- medlemslandene og EØS- landene, specielt med hensyn til afsnittene om indikation, dosering og indgivelsesvej, kontraindikationer, særlige advarsler og forsigtighedsregler vedrørende brugen samt interaktion med andre lægemidler eller andre former for interaktion.
The Referral procedure under Article 30 of Directive 2001/ 83/ EC, as amended for Risperdal was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to the sections on indication, posology and method of administration, contraindications, special warnings and precautions for use and interactions with other medicinal products or other forms of interactions.
CHMP vurderede den foreslåede formulering, der var fremlagt af indehaveren af markedsføringstilladelsen, og specielt blev der lagt vægt på følgende punkter:
The CHMP assessed the proposed wording provided by the MAH, and particular attention was given to the following issues:
For indikationen skizofreni vurderede CHMP den foreslåede dosering og var af den opfattelse, at selv om 8 mg dosis kunne betragtes som en behandlingsmulighed for visse patienter med skizofreni, bør de behandlende læger individualisere behandlingen og benytte den laveste effektive dosis for hver enkelt patient med en måldosis på 4 til 6 mg/ dag.
For the indication in Schizophrenia, the CHMP assessed the proposed dosing, and was of the opinion that although the 8 mg dose could be considered as a treatment option for particular patients with schizophrenia, treating physicians should individualise treatment and use the lowest efficacious dose for each patient with a target dose of 4 to 6 mg/ day.
Vedrørende doseringen til ældre personer med skizofreni anså CHMP, at dokumentationen for ældre patienter er begrænset, men foreslår, at der anbefales en lavere startdosis med en mere forsigtig dosistitrering end hos yngre voksne og vedtog følgende formulering:
Regarding the posology in elderly with schizophrenia, the CHMP considered that the data in elderly patients is limited but suggests that a lower starting dose with a more conservative dose titration than in younger adults is recommended and adopted the following wording:
“ Der anbefales en startdosis på 0, 5 mg to gange daglig.
“ A starting dose of 0.5 mg twice daily is recommended.
Denne dosis kan individuelt justeres med 0, 5 mg to gange daglig i trin a 1- 2 mg to gange daglig. ”
This dosage can be individually adjusted with 0.5 mg twice-daily increments to 1 to 2 mg twice daily .”
For indikationen maniske episoder i forbindelse med bipolær lidelse vurderede CHMP sikkerhed og effektivitet for de foreslåede startdoser på 2 mg og bemærkede, at der ikke var foretaget nogen sammenligninger af ændring i effektivitetsmåling i de første dage af behandlingen.
For the indication in Manic episodes associated with Bipolar Disorders, the CHMP assessed the safety and efficacy of the proposed 2 mg and 3 mg starting doses and noted that no comparisons on the change in efficacy measurements in the first days of treatment were made.
Derfor var CHMP af den opfattelse, at startdoserne skulle begrænses til 2 mg for den første dag ved bipolær mani.
Therefore the CHMP was of the opinion that starting doses should be restricted to 2 mg for the first day in bipolar mania.
CHMP vurderede også det optimale anbefalede dosisområde for bipolær mani og anså, baseret på den fremlagte effektivitetsanalyse af risperidon- patienter grupperet efter deres form for daglig dosis under undersøgelsen, at effektiviteten var dokumenteret over det anbefalede dosisområde 1 til 6 mg/ dag, og at visse patienter kan behandles effektivt med doser i den lavere ende af dette dosisområde.
The CHMP also assessed the optimal, recommended dose range for bipolar mania and considered, based on the submitted efficacy analysis of risperidone patients, grouped according to their mode daily dose during the study, that efficacy was demonstrated over the recommended dose range 1 to 6 mg/ day, and that some patients can effectively be treated at doses in the lower end of this dose range.
CHMP vurderede også effektivitetsdata for bipolær mani hos ældre patienter.
The CHMP also assessed the efficacy data for bipolar mania in elderly patients.
På grund af det lave antal patienter og baseret på den begrænsede tilgængelige dokumentation anså CHMP det ikke for berettiget at behandle ældre med bipolær mani med den dosering, der anbefales til voksne.
Due to the low number of patients and based on the limited data available, the CHMP did not consider it justified to treat elderly with bipolar mania with the posology recommended in adults.
CHMP konkluderede, at den øvre doseringsgrænse burde begrænses og vedtog følgende doseringsanbefalinger:
The CHMP concluded that the upper limit of dosage should be restricted and adopted the following dosage recommendations:
Denne dosis kan individuelt justeres med 0, 5 mg to gange daglig i trin a 1- 2 mg to gange daglig.
This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Da den kliniske erfaring med ældre patienter er begrænset, bør der udvises forsigtighed. ”
Since clinical experience in elderly is limited, caution should be exercised .”
Endelig vurderede CHMP de oplysninger, der var fremlagt om brugen af risperidon til behandling af milde former for mani.
Finally, the CHMP assessed the data submitted on the use of risperidone in the treatment of mild forms of mania.
På grund af det lille antal patienter med mild mani i kliniske undersøgelser og den begrænsede tilgængelige dokumentation kunne CHMP ikke garantere, at balancen mellem effektivitet og sikkerhed hos patienter med mild mani er den samme som hos patienter med moderat til svær mani.
Given the small number of patients with mild mania in clinical trials and the limited data available, the CHMP could not guarantee that the balance between efficacy and safety in patients with mild mania is the same as in patients with moderate to severe mania.
CHMP vedtog derfor følgende formulering på linje med indikationen for andre godkendte psykofarmaka:
The CHMP therefore adopted the following wording in line with the indication for other approved antipsychotics:
“ Risperdal er indiceret til behandling af moderate til svære maniske episoder i forbindelse med bipolære lidelser. ”
“ Risperdal is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders .”