INN Invented Name Strength Pharmaceutical Form. 0,5 mg - Tabletten. 1mg - Tabletten. 2 mg - Tabletten. 3 mg - Tabletten.
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- Jemima Warner
- 7 years ago
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1 ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1
2 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Austria Austria Austria Austria Austria Austria Austria Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Risperidon Risperidon Risperidon Risperidon Risperidon Risperdal Quicklet 0,5 mg - Tabletten Risperdal Quicklet 1mg - Tabletten Risperdal Quicklet 2 mg - Tabletten Risperdal Quicklet 3 mg - Tabletten Risperdal Quicklet 4 mg - Tabletten Risperidon Risperdal 0,5 mg - Filmtabletten Risperidon Risperdal 1 mg - Filmtabletten Risperidon Risperdal 2 mg - Filmtabletten 0,5 mg Orodispersible tablet Oral use 1 mg Orodispersible tablet Oral use 2 mg Orodispersible tablet Oral use 3 mg Orodispersible tablet Oral use 4 mg Orodispersible tablet Oral use 0,5 mg Film-coated tablet Oral use 1 mg Film-coated tablet Oral use 2 mg Film-coated tablet Oral use 2
3 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Austria Austria Austria Austria Austria Austria Austria Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Risperidon Risperdal 3 mg - Filmtabletten Risperidon Risperdal 4 mg - Filmtabletten Risperidon Risperdal 6 mg - Filmtabletten Risperidon Risperdal 1 mg/ml - orale Lösung Risperidon Rispolin Quicklet 0,5 mg - Tabletten Risperidon Rispolin Quicklet 1 mg - Tabletten Risperidon Rispolin Quicklet 2 mg - Tabletten Risperidon Rispolin Quicklet 3 mg - Tabletten 3 mg Film-coated tablet Oral use 4 mg Film-coated tablet Oral use 6 mg Film-coated tablet Oral use 1 mg Oral solution Oral use 1 mg/ 1 ml 0,5 mg Orodispersible tablet Oral use 1 mg Orodispersible tablet Oral use 2 mg Orodispersible tablet Oral use 3 mg Orodispersible tablet Oral use 3
4 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Austria Austria Austria Austria Austria Austria Austria Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria Risperidon Rispolin Quicklet 4 mg - Tabletten Risperidon Rispolin 0,5 mg - Filmtabletten Risperidon Rispolin 1 mg- Filmtabletten Risperidon Rispolin 2 mg - Filmtabletten Risperidon Rispolin 3 mg - Filmtabletten Risperidon Rispolin 4 mg - Filmtabletten Risperidon Rispolin 6 mg - Filmtabletten Risperidon Rispolin 1 mg/ml - orale Lösung 4 mg Orodispersible tablet Oral use 0,5 mg Film-coated tablet Oral use 1 mg Film-coated tablet Oral use 2 mg Film-coated tablet Oral use 3 mg Film-coated tablet Oral use 4 mg Film-coated tablet Oral use 6 mg Film-coated tablet Oral use 1 mg Oral solution Oral use 1 mg/ 1 ml 4
5 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Risperidone Risperidone J-C Instasolv 0.5 mg Orodispersible tablet Oral use Risperidone Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Risperdal 0.5 mg Film-coated tablet Oral use Risperidone Risperdal 1 mg Film-coated tablet Oral use Risperidone Risperdal 2 mg Film-coated tablet Oral use Risperidone Risperdal 3 mg Film-coated tablet Oral use Risperidone Risperdal 4 mg Film-coated tablet Oral use Risperidone Risperdal 6 mg Film-coated tablet Oral use Risperidone Risperdal Instasolv 0.5 mg Orodispersible tablet Oral use Risperidone Risperdal Instasolv 1 mg Orodispersible tablet Oral use Risperidone Risperdal Instasolv 2 mg Orodispersible tablet Oral use 5
6 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Berchem, Bulgaria Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Janssen Cilag N.V. Roderveldlaan 1 B-2600 Berchem, Johnson & Johnson D.O.O. Smartinska cesta Ljubljana Slovenia Risperidone Risperidone J-C 0.5 mg Film-coated tablet Oral use Risperidone Risperidone J-C 1 mg Film-coated tablet Oral use Risperidone Risperidone J-C 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Risperidone J-C 2 mg Film-coated tablet Oral use Risperidone Risperidone J-C 3 mg Film-coated tablet Oral use Risperidone Risperidone J-C 4 mg Film-coated tablet Oral use Risperidone Risperidone J-C 6 mg Film-coated tablet Oral use Risperidone Risperidone Risperidone J-C Instasolv Risperidone J-C Instasolv 1 mg Orodispersible tablet Oral use 2 mg Orodispersible tablet Oral use Risperidone Rispolept 1mg Oral solution Oral use 1 mg/ 1 ml 6
7 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Bulgaria Bulgaria Bulgaria Bulgaria Cyprus Cyprus Cyprus Cyprus Cyprus Czech Republic Czech Republic Johnson & Johnson D.O.O. Smartinska cesta 53, 1000 Ljubljana, Slovenia Risperidone Rispolept 1 mg Film coated tablet Oral use Johnson & Johnson D.O.O. Risperidone Rispolept 2 mg Film coated tablet Oral use Smartinska cesta 53, 1000 Ljubljana, Slovenia Johnson & Johnson D.O.O. Risperidone Rispolept 3 mg Film coated tablet Oral use Smartinska cesta 53, 1000 Ljubljana, Slovenia Johnson & Johnson D.O.O. Risperidone Rispolept 4 mg Film coated tablet Oral use Smartinska cesta 53, 1000 Ljubljana, Slovenia Janssen-Cilag International NV, Risperidone Risperdal 1 mg Film-coated tablets Oral use Turnhoutseweg 30, B-2340, Beerse, Janssen-Cilag International NV, Risperidone Risperdal 2 mg Film-coated tablets Oral use Turnhoutseweg 30, B-2340, Beerse, J Janssen-Cilag International Risperidone Risperdal 3 mg Film-coated tablets Oral use NV, Turnhoutseweg 30, B-2340, Beerse, Janssen-Cilag International NV, Risperidone Risperdal 4mg Film-coated tablets Oral use Turnhoutseweg 30, B-2340, Beerse, Janssen-Cilag International NV, Risperidone Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml Turnhoutseweg 30, B-2340, Beerse, Janssen-Cilag s.r.o. Risperidonum Risperdal 1 mg 1 mg Film-coated tablet oral use Karla Engliše 3201/ Praha 5 Czech Republic Janssen-Cilag s.r.o. Risperidonum Risperdal 2 mg 2 mg Film-coated tablet oral use Karla Engliše 3201/6 7
8 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Praha 5 Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Denmark Denmark Denmark Denmark Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 Janssen-Cilag A/S Postboks 149 Hammerbakken Birkerød Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Risperidonum Risperdal 3 mg 3 mg Film-coated tablet oral use Risperidonum Risperdal 4 mg 4 mg Film-coated tablet oral use Risperidonum Risperdal 1 mg Oral solution oral use 1 mg/ 1 ml Risperidonum Risperdal Quicklet 2 mg Orodispersible tablet oral use Risperidonum 3 mg Orodispersible tablet Risperidonum Risperdal Quicklet 4 mg Orodispersible tablet oral use Risperidone Belivon 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Belivon 1 mg Film-coated Oral use Risperidone Belivon 2 mg Film-coated Oral use Risperidone Belivon 3 mg Film-coated Oral use 8
9 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Birkerød, Denmark Denmark Denmark Denmark Denmark Denmark Denmark Denmark Denmark Denmark Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark Janssen-Cilag A/S Postboks 149 Hammerbakken Birkerød Risperidone Belivon 4 mg Film-coated Oral use Risperidone Risperdal 0,5 mg Film-coated tablets Oral use Risperidone Risperdal 1 mg Film-coated tablets Oral use Risperidone Risperdal 2 mg Film-coated tablets Oral use Risperidone Risperdal 3 mg Film-coated tablets Oral use Risperidone Risperdal 4 mg Film-coated tablets Oral use Risperidone Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Risperdal 0,5 mg Oral lyophilisate Oral use Risperidone Risperdal 1 mg Oral lyophilisate Oral use Risperidone Risperdal 2 mg Oral lyophilisate Oral use 9
10 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Denmark Estonia Estonia Estonia Estonia Estonia Estonia Estonia Finland Johnson & Johnson UAB Šeimyniškių g. 1A LT Vilnius Lithuania Johnson & Johnson UAB Šeimyniškių g. 1A LT Vilnius Lithuania Johnson & Johnson UAB Šeimyniškių g. 1A LT Vilnius Lithuania Johnson & Johnson UAB Šeimyniškių g. 1A LT Vilnius Lithuania Johnson & Johnson UAB Šeimyniškių g. 1A LT Vilnius Lithuania Johnson & Johnson UAB Šeimyniškių g. 1A LT Vilnius Lithuania Johnson & Johnson UAB Šeimyniškių g. 1A LT Vilnius Lithuania Jansen-Cilag Oy Metsänneidonkuja Espoo Risperidone Rispolept 1 mg Film-coated tablet Oral use Risperidone Rispolept 2 mg Film-coated tablet Oral use Risperidone Rispolept 3 mg Film-coated tablet Oral use Risperidone Rispolept 4 mg Film-coated tablet Oral use Risperidone Rispolept 1 mg/ml Oral solution Oral use 1 mg/ 1 ml Risperidone Rispolept Quicklet 1 mg Orodispersible tablet Oral use Risperidone Rispolept Quicklet 2 mg Orodispersible tablet Oral use Risperidone Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml 10
11 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Finland Finland Finland Finland Finland Finland Finland Finland Finland Finland Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Risperidone Risperdal 0.25 mg Film-coated tablet Oral use Risperidone Risperdal 0.5 mg Film-coated tablet Oral use Risperidone Risperdal 1 mg Film-coated tablet Oral use Risperidone Risperdal 2 mg Film-coated tablet Oral use Risperidone Risperdal 3 mg Film-coated tablet Oral use Risperidone Risperdal 4 mg Film-coated tablet Oral use Risperidone Risperdal 6 mg Film-coated tablet Oral use Risperidone Risperdal Instasolv 0.5 mg Orodispersible tablet Oral use Risperidone Risperdal Instasolv 1 mg Orodispersible tablet Oral use Risperidone Risperdal Instasolv 2 mg Orodispersible tablet Oral use 11
12 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Finland Finland France France France France France France Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Jansen-Cilag Oy Metsänneidonkuja Espoo Finland Laboratorires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratorires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratorires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins Risperidone Risperdal Instasolv 3 mg Orodispersible tablet Oral use Risperidone Risperdal Instasolv 4 mg Orodispersible tablet Oral use Risperidone Belivon 1 mg Scored tablet Oral use Risperidone Belivon 2 mg Scored tablet Oral use Risperidone Belivon 3 mg Scored tablet Oral use Risperidone Belivon 4 mg Scored tablet Oral use Risperidone Risperdal 0.5 mg Film coatedtablet Oral use Risperidone Risperdal 1 mg Half-Scored tablet Oral use 12
13 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) France France France France France France TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Risperidone Risperdal 2 mg Half-Scored tablet Oral use Risperidone Risperdal 3 mg Half-Scored tablet Oral use Risperidone Risperdal 4 mg Half-Scored tablet Oral use Risperidone Risperdal 1mg/ml Oral solution Oral use 1 mg/ 1 ml Risperidone Risperdaloro 0.5 mg Orodispersible Tablet Risperidone Risperdaloro 1 mg Orodispersible Tablet Oral use Oral use 13
14 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) France France France Germany Germany Germany Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Laboratoires Janssen Cilag 1 rue Desmoulins TSA Issy les Moulineaux Cedex 9, France Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Risperidone Risperdaloro 2 mg Orodispersible Tablet Risperidone Risperdaloro 3 mg Orodispersible Tablet Risperidone Risperdaloro 4 mg Orodispersible Tablet Oral use Oral use Oral use Risperidon Risperdal 1 mg 1 mg Film-coated tablet Oral use Risperidon Risperdal 2 mg 2 mg Film-coated tablet Oral use Risperidon Risperdal 3 mg 3 mg Film-coated tablet Oral use 14
15 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Germany Germany Germany Germany Germany Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Risperidon Risperdal 4 mg 4 mg Film-coated tablet Oral use Risperidon Risperidon Risperidon Risperdal Filmtabletten 0,25 mg Risperdal Filmtabletten 0,5 mg Risperdal Filmtabletten 6 mg Risperidon Risperdal Lösung 1 mg/ml Risperidon Risperdal Quicklet 1 mg 0.25 mg Film-coated tablet Oral use 0.5 mg Film-coated tablet Oral use 6 mg Film-coated tablet Oral use 1 mg Oral solution Oral use 1 mg/ 1 ml 1 mg Orodispersible tablet Oral use 15
16 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Germany Germany Germany Germany Germany Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Risperidon Risperidon Risperidon Risperidon Risperidon Risperdal Quicklet 2 mg Risperdal Quicklet 3 mg Risperdal Quicklet 4 mg Risperidon-Janssen Filmtabletten 6 mg Risperidon-Janssen Loesung 1 mg/ml 2 mg Orodispersible tablet Oral use 3 mg Orodispersible tablet Oral use 4 mg Orodispersible tablet Oral use 6 mg Film-coated tablet Oral use 1 mg Oral solution Oral use 1 mg/ 1 ml 16
17 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Germany Germany Germany Germany Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Risperidon Risperidon Risperidon Risperidon Risperidon Belivon 0,5 mg Filmtabletten Belivon 1 mg Filmtabletten Belivon 1mg/ml Lösung Belivon 2 mg Filmtabletten Belivon 3 mg Filmtabletten 0.5 mg Film-coated tablet Oral use 1 mg Film-coated tablet Oral use 1 mg Oral solution Oral use 1 mg/ 1 ml 2 mg Film-coated tablet Oral use 3 mg Film-coated tablet Oral use 17
18 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Germany Germany Germany Germany Germany Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss. Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss Risperidon Risperidon Belivon 4 mg Filmtabletten Belivon 6 mg Filmtabletten 4 mg Film-coated tablet Oral use 6 mg Film-coated tablet Oral use Risperidon Rehablit 1 mg 1 mg Film-coated tablet Oral use Risperidon Rehablit 2 mg 2 mg Film-coated tablet Oral use Risperidon Rehablit 3 mg 3 mg Film-coated tablet Oral use Risperidon Rehablit 4 mg 4 mg Film-coated tablet Oral use 18
19 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Germany Germany Greece Greece Greece Greece Greece or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag GmbH Neuss or Janssen-Cilag GmbH Raiffeisenstr Neuss, Germany Janssen-Cilag Pharmaceutical S.A.C.I 56 Eirinis Avenue 56 Pefki, Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Risperidon Rehablit Filmtabletten 6 mg Risperidon Rehablit Lösung 1 mg/ml 6 mg Film-coated tablet Oral use 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Risperdal 1 mg Film-coated tablet Oral use Risperidone Risperdal 2 mg Film-coated tablet Oral use Risperidone Risperdal 3 mg Film-coated tablet Oral use Risperidone Risperdal 4 mg Film-coated tablet Oral use Risperidone Risperdal 6 mg Film-coated tablet Oral use 19
20 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Greece Janssen-Cilag Pharmaceutical S.A.C.I, 56 Eirinis Avenue, Pefki, 15121, Greece Hungary Janssen- Cilag Kft Törökbálint Tó park Hungary Hungary Janssen- Cilag Kft Törökbálint Tó park, Hungary Hungary Janssen- Cilag Kft Törökbálint Tó park, Hungary Hungary Janssen- Cilag Kft Törökbálint Tó park, Hungary Hungary Janssen- Cilag Kft Törökbálint Tó park, Hungary Risperidone Risperdal 8 mg Film-coated tablet Oral use Risperidone Risperdal 1 mg/1 ml Oral Solution Oral use 1 mg/ 1 ml Risperidone Risperdal Quicklet 0.5 mg Lingual tablet Oral use Risperidone Risperdal Quicklet 1 mg Lingual tablet Oral use Risperidone Risperdal Quicklet 2 mg Lingual tablet Oral use Risperidone Risperdal Quicklet 3 mg Lingual tablet Oral use Risperidone Risperdal Quicklet 4 mg Lingual tablet Oral use Risperidone Risperdal 1 mg Film coated tablet Oral use Risperidone Risperdal 2 mg Film coated tablet Oral use Risperidone Risperdal 3 mg Film coated tablet Oral use Risperidone Risperdal 4 mg Film coated tablet Oral use Risperidone Risperdal 1mg Oral solution Oral use 1 mg/ 1 ml 20
21 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Hungary Janssen- Cilag Kft Törökbálint Tó park, Hungary Hungary Janssen- Cilag Kft Törökbálint Tó park, Hungary Hungary Janssen- Cilag Kft Törökbálint Tó park Hungary Iceland Janssen-Cilag AB Box Sollentuna Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Iceland Janssen-Cilag AB, Box Sollentuna, Sverige Risperidone Risperdal Quicklet 2 mg Orodispersible tablet Oral use Risperidone Risperdal Quicklet 3 mg Orodispersible tablet Oral use Risperidone Risperdal Quicklet 4 mg Orodispersible tablet Oral use Risperidonum Risperdal 0,5 mg Oral lyophilisate Oral use Risperidonum Risperdal 1 mg Oral lyophilisate Oral use Risperidonum Risperdal 2 mg Oral lyophilisate Oral use Risperidonum Risperdal 3 mg Oral lyophilisate Oral use Risperidonum Risperdal 4 mg Oral lyophilisate Oral use Risperidonum Risperdal 0,5 mg Film coated tablet Oral use Risperidonum Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidonum Risperdal 1 mg Film Coated tablet Oral use Risperidonum Risperdal 2 mg Film Coated tablet Oral use Risperidonum Risperdal 3 mg Film Coated tablet Oral use Risperidonum Risperdal 4 mg Film Coated tablet Oral use 21
22 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Ireland Ireland Ireland Ireland Ireland Ireland Ireland Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Risperidone Risperdal Liquid 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Risperdal 6 mg Film Coated Tablet Oral use Risperidone Risperdal 1 mg Film Coated Tablet Oral use Risperidone Risperdal 2 mg Film Coated Tablet Oral use Risperidone Risperdal 3 mg Film Coated Tablet Oral use Risperidone Risperdal 4 mg Film Coated Tablet Oral use Risperidone Risperdal 0.25 mg Film Coated Tablet Oral use 22
23 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Ireland Ireland Ireland Ireland Ireland Ireland Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom Risperidone Risperdal 0.5 mg Film Coated Tablet Oral use Risperidone Risperidone Risperidone Risperidone Risperidone Risperdal Quicklet 0.5 mg Risperdal Quicklet Risperdal Quicklet Risperdal Quicklet 1 mg 2 mg 3 mg Risperdal Quicklet 4 mg Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Oral use Oral use Oral use Oral use Oral use 23
24 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Italy Italy Italy Italy Italy Italy Italy Janssen Cilag Spa Via Michelangelo Buonarroti n. 23 Cologno Monzese 20093, Milano Italy Risperidone Risperdal 1 mg Film coated tablet Oral use Janssen Cilag Spa Risperidone Risperdal 2 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 3 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 4 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 0,5 mg Tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 0,25 mg Tablet Oral use Via Michelangelo Buonarroti n. 24
25 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Italy Italy Italy Italy Italy Italy 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 6 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 0,5 mg Orodispersible tablet Oral Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 1 mg Orodispersible tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Janssen Cilag Spa Risperidone Risperdal 2 mg Orodispersible tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy J.C. HEALTHCARE srl Risperidone BELIVON 1 mg Oral solution Oral use 1 mg/ 1 ml Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy J.C. HEALTHCARE srl Risperidone BELIVON 1 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese 25
26 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Italy Italy Italy Italy Italy Milano Italy J.C. HEALTHCARE srl Risperidone BELIVON 2 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy J.C. HEALTHCARE srl Risperidone BELIVON 3 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy J.C. HEALTHCARE srl Risperidone BELIVON 4 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy J.C. HEALTHCARE srl Risperidone ACTASE 1 mg Oral solution Oral use 1 mg/ 1 ml Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy J.C. HEALTHCARE srl Risperidone ACTASE 1 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy 26
27 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Italy Italy Italy Latvia Latvia Latvia Latvia Latvia J.C. HEALTHCARE srl Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy Risperidone ACTASE 2 mg Film coated tablet Oral use J.C. HEALTHCARE srl Risperidone ACTASE 3 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy J.C. HEALTHCARE srl Risperidone ACTASE 4 mg Film coated tablet Oral use Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy UAB Johnson &Johnson Risperidone Rispolept 1 mg Tablets Oral use Šeimyniškių g.1a LT Vilnius Lithuania UAB Johnson &Johnson, Risperidone Rispolept 2 mg Tablets Oral use Šeimyniškių g.1a, LT Vilnius, Lithuania UAB Johnson&Johnson, Risperidone Rispolept 3 mg Tablets Oral use Šeimyniškių g.1a, Vilnius, Lithuania UAB Johnson&Johnson, Risperidone Rispolept 4 mg Tablets Oral use Šeimyniškių g.1a, LT Vilnius, Lithuania UAB Johnson&Johnson, Risperidone Rispolept 1 mg Oral solution Oral use 1 mg/ 1 ml Šeimyniškių g.1a, LT
28 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Vilnius, Lithuania Latvia Latvia Latvia Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania UAB Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania UAB Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania UAB Johnson & Johnson, Šeimyniškių g.1a, LT Vilnius, Lithuania UAB,,Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania UAB,,Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania UAB,,Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania UAB,,Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania UAB,,Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania UAB,,Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania UAB,,Johnson & Johnson, Šeimyniškių g. 1A, LT Vilnius, Lithuania Risperidone Risperdal Quicklet 1 mg Orodispersible tablets Risperidone Risperdal Quicklet 2 mg Orodispersible tablets Risperidone Risperdal Quicklet 4 mg Orodispersible tablets Oral use Oral use Oral use Risperidone Rispolept 1 mg Film-coated tablets Oral use Risperidone Rispolept 2 mg Film-coated tablets Oral use Risperidone Rispolept 3 mg Film-coated tablets Oral use Risperidone Rispolept 4 mg Film-coated tablets Oral use Risperidone Rispolept 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Rispolept Quicklet 1 mg Orodispersible tablets Risperidone Rispolept Quicklet 2 mg Orodispersible tablets Oral use Oral use 28
29 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Janssen Cilag N.V. Risperidone Roderveldlaan Berchem Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Janssen Cilag N.V. Roderveldlaan Berchem, Risperidone J-C Instasolv 0.5 mg Orodispersible tablet Oral use Risperidone Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Risperdal 0.5 mg Film-coated tablet Oral use Risperidone Risperdal 1 mg Film-coated tablet Oral use Risperidone Risperdal 2 mg Film-coated tablet Oral use Risperidone Risperdal 3 mg Film-coated tablet Oral use Risperidone Risperdal 4 mg Film-coated tablet Oral use Risperidone Risperdal 6 mg Film-coated tablet Oral use Risperidone Risperdal Instasolv 0.5 mg Orodispersible tablet Oral use Risperidone Risperdal Instasolv 1 mg Orodispersible tablet Oral use Risperidone Risperdal Instasolv 2 mg Orodispersible tablet Oral use 29
30 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Malta Janssen Cilag N.V. Roderveldlaan Berchem, Risperidone Risperidone J-C 0.5 mg Film-coated tablet Oral use Janssen Cilag N.V. Risperidone Risperidone J-C 1 mg Film-coated tablet Oral use Roderveldlaan Berchem, Janssen Cilag N.V. Risperidone Risperidone J-C 1 mg Oral solution Oral use 1 mg/ 1 ml Roderveldlaan Berchem, Janssen Cilag N.V. Risperidone Risperidone J-C 2 mg Film-coated tablet Oral use Roderveldlaan Berchem, Janssen Cilag N.V. Risperidone Risperidone J-C 3 mg Film-coated tablet Oral use Roderveldlaan Berchem, Janssen Cilag N.V. Risperidone Risperidone J-C 4 mg Film-coated tablet Oral use Roderveldlaan Berchem, Janssen Cilag N.V. Risperidone Risperidone J-C 6 mg Film-coated tablet Oral use Roderveldlaan Berchem, Janssen Cilag N.V. Risperidone Risperidone J-C 1 mg Orodispersible tablet Oral use Roderveldlaan Berchem, Instasolv Janssen Cilag N.V. Roderveldlaan Berchem, Janssen-Cilag International NV Turnhoutseweg Beerse Risperidone Risperidone J-C Instasolv 2 mg Orodispersible tablet Oral use Risperidone Risperdal 1mg Tablets Oral use 30
31 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Malta Malta Malta Malta Malta Malta Netherlands Netherlands Janssen-Cilag International NV Turnhoutseweg Beerse Janssen-Cilag International NV Turnhoutseweg Beerse Janssen-Cilag International NV Turnhoutseweg Beerse Janssen-Cilag International NV Turnhoutseweg Beerse Janssen-Cilag International NV Turnhoutseweg Beerse Janssen-Cilag International NV Turnhoutseweg Beerse Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg Risperidone Risperdal 2 mg Tablets Oral use Risperidone Risperdal 3 mg Tablets Oral use Risperidone Risperdal 1 mg Oral Solution Oral use 1 mg/ 1 ml Risperidone Risperdal Quicklets 0.5mg Orodispersible tablets Risperidone Risperdal Quicklets 1 mg Orodispersible tablets Risperidone Risperdal Quicklets 2 mg Orodispersible tablets Risperidon Risperidon Risperdal Risperdal omhulde tabletten 0,5 mg Oral use Oral use Oral use 0.5 mg Filmcoated talbets Oral use Risperdal Risperdal 1 mg Filmcoated tablets Oral use omhulde tabletten 1 mg 31
32 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) The Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Risperidon Risperidon Risperidon Risperidon Risperidon Risperidon Risperdal Risperdal omhulde tabletten 2 mg Risperdal Risperdal omhulde tabletten 3 mg Risperdal Risperdal omhulde tabletten 4 mg Risperdal Risperdal omhulde tabletten 6 mg Risperdal Risperdal omhulde tabletten 8 mg Belivon Belivon omhulde tabletten 1 mg 2 mg Filmcoated tablets Oral use 3 mg Filmcoated tablets Oral use 4 mg Filmcoated tablets Oral use 6 mg Filmcoated tablets Oral use 8 mg Filmcoated tablets Oral use 1 mg Filmcoated tablets Oral use 32
33 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box Risperidon Risperidon Belivon Belivon omhulde tabletten 2 mg Belivon Belivon omhulde tabletten 3 mg 2 mg Filmcoated tablets Oral use 3 mg Filmcoated tablets Oral use Risperidon Belivon 4 mg Filmcoated tablets Oral use Risperidon Risperidon Risperidon Risperidon Risperdal Risperdal 1 mg/ml, drank Belivon Belivon 1 mg/ml Risperdal Quicklet Risperdal Quicklet 0,5 mg Risperdal Quicklet Risperdal Quicklet 1 mg 1 mg Oral solution Oral use 1 mg/ 1 ml 1 mg Oral solution Oral use 1 mg/ 1 ml 0.5 mg Orodisperable tablet Oral use 1 mg Orodisperable tablet Oral use 33
34 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Netherlands Netherlands Netherlands Norway Norway Norway Norway Norway 5000 LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 PO Box LT Tilburg The Netherlands Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D Risperidon Risperidon Risperidon Risperdal Quicklet Risperdal Quicklet 2 mg Risperdal Quicklet Risperdal Quicklet 3 mg Risperdal Quicklet Risperdal Quicklet 4 mg 2 mg Orodisperable tablet Oral use 3 mg Orodisperable tablet Oral use 4 mg Orodisperable tablet Oral use Risperidone Belivon 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Belivon 1 mg Film-coated tablet Oral use Risperidone Belivon 2 mg Film-coated tablet Oral use Risperidone Belivon 3 mg Film-coated tablet Oral use Risperidone Belivon 4 mg Film-coated tablet Oral use 34
35 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) 0275 Oslo Norway Norway Norway Norway Norway Norway Norway Norway Norway Norway Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Risperidone Risperdal 0,5 mg Orodispersible tablet Oral use Risperidone Risperdal 1 mg Orodispersible tablet Oral use Risperidone Risperdal 2 mg Orodispersible tablet Oral use Risperidone Risperdal 3 mg Orodispersible tablet Oral use Risperidone Risperdal 4 mg Orodispersible tablet Oral use Risperidone Risperdal 0,5 mg Film-coated tablet Oral use Risperidone Risperdal 1 mg Film-coated tablet Oral use Risperidone Risperdal 2 mg Film-coated tablet Oral use Risperidone Risperdal 3 mg Film-coated tablet Oral use Risperidone Risperdal 4 mg Film-coated tablet Oral use 35
36 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Norway Poland Poland Poland Poland Poland Poland Poland Poland Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway Risperidone Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml Janssen-Cilag International N.V. Risperidone Rispolept 1 mg Oral solution Oral use 1 mg/ 1 ml Turnhauseveg 30 B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept 1 mg Film-coated tablet Oral use Turnhauseveg 30 B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept 2 mg Film-coated tablet Oral use Turnhauseveg 30 B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept 3 mg Film-coated tablet Oral use Turnhauseveg 30 B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept 4 mg Film-coated tablet Oral use Turnhauseveg 30 B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept Quicklet 0,5 mg Orodispersible tablet Oral use Turnhauseveg 30 B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept Quicklet 1 mg Orodispersible tablet Oral use Turnhauseveg 30 B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept Quicklet 2 mg Orodispersible tablet Oral use Turnhauseveg 30 36
37 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Poland Poland Portugal Portugal Portugal Portugal B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept Quicklet 3 mg Orodispersible tablet Oral use Turnhauseveg 30 B-2340 Beerse Janssen-Cilag International N.V. Risperidone Rispolept Quicklet 4 mg Orodispersible tablet Oral use Turnhauseveg 30 B-2340 Beerse Janssen Farmacêutica Portugal Risperidona Risperdal 1 mg Film-coated tablet Oral use Lda. Estrada Consiglieri Pedroso 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Risperidona Risperdal 2 mg Film-coated tablet Oral use Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Risperidona Risperdal 3 mg Film-coated tablet Oral use Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Risperidona Risperdal 4 mg Film-coated tablet Oral use Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal 37
38 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Portugal Portugal Portugal Portugal Portugal Portugal Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 Risperidona Risperdal 1 mg Oral solution Oral use Risperidona Risperdal 0.25 mg Film-coated tablet Oral use Risperidona Risperdal 0.5 mg Film-coated tablet Oral use Risperidona Risperdal Quicklet 0.5 mg Orodispersible tablet Oral use Risperidona Risperdal Quicklet 1 mg Orodispersible tablet Oral use Risperidona Risperdal Quicklet 2 mg Orodispersible tablet Oral use Risperidona Risperdal Quicklet 3 mg Orodispersible tablet Oral use 38
39 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Portugal Romania Romania Romania Romania Romania Romania Romania Slovak Republic A - Queluz de Baixo Barcarena Portugal Janssen Farmacêutica Portugal, Risperidona Risperdal Quicklet 4 mg Orodispersible tablet Oral use Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo Barcarena Portugal Janssen Pharmaceutica N.V. Risperidone Rispolept 1 mg 1 mg Film-coated tablets Oral use Turnhoutseweg Beerse Janssen Pharmaceutica N.V. Risperidone Rispolept 2 mg 2 mg Film-coated tablets Oral use Turnhoutseweg Beerse Janssen Pharmaceutica N.V. Risperidone Rispolept 3 mg 3 mg Film-coated tablets Oral use Turnhoutseweg 30, 2340 Beerse, Janssen Pharmaceutica N.V. Risperidone Rispolept 4 mg 4 mg Film-coated tablets Oral use Turnhoutseweg 30, 2340 Beerse, Janssen Pharmaceutica N.V. Risperidone Rispolept 1 mg Oral solution Oral use 1 mg/ 1 ml Turnhoutseweg 30, 2340 Beerse, Janssen Pharmaceutica N.V. Risperidone Rispolept Quicklet 1 mg Dispersible tablets Oral use Turnhoutseweg 30, 2340 Beerse, Janssen Pharmaceutica N.V. Risperidone Rispolept Quicklet 2 mg Dispersible tablets Oral use Turnhoutseweg 30, 2340 Beerse, Johnson & Johnson s.r.o. Risperidone Risperdal 1 mg Film coated tablet Oral use Plynárenská 7/B Bratislava 39
40 Member State Marketing Authorisation Holder INN Invented Name Strength Pharmaceutical Form Route of administration Content (concentration) Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava Slovak Republic Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava Slovak Republic Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava Slovak Republic Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava Slovak Republic Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava Slovak Republic Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava Slovak Republic Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava Slovak Republic Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava Risperidone Risperdal 2 mg Film coated tablet Oral use Risperidone Risperdal 3 mg Film coated tablet Oral use Risperidone Risperdal 4 mg Film coated tablet Oral use Risperidone Risperdal 1 mg Oral solution Oral use 1 mg/ 1 ml Risperidone Risperdal Quicklet 1 mg Orodispersible tablet Oral use Risperidone Risperdal Quicklet 2 mg Orodispersible tablet Oral use Risperidone Risperdal Quicklet 3 mg Orodispersible tablet Oral use Risperidone Risperdal Quicklet 4 mg Orodispersible tablet Oral use 40
Name. Priligy 30 mg Filmtabletten. Priligy 60 mg Filmtabletten. Priligy 30 mg filmomhulde tablet. Priligy 60 mg filmomhulde tablet
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