Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2014-09-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014337EN.01001201.xml










26.9.2014   


EN


Official Journal of the European Union


C 337/12





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
2014/C 337/03
—   Issuing, maintenance or modification of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




19.8.2014


Estradiol


See Annex I


See Annex I


See Annex I


20.8.2014




6.8.2014


Dexamed


See Annex II


See Annex II


See Annex II


7.8.2014




26.8.2014


Sandostatin LAR


See Annex III


See Annex III


See Annex III


28.8.2014




26.8.2014


Sandostatin


See Annex IV


See Annex IV


See Annex IV


28.8.2014




6.8.2014


Seroquel-Seroquel XR


See Annex V


See Annex V


See Annex V


7.8.2014






(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.


ANNEX I
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
0,01
% w/w estradiol containing medicinal products for topical use













Member State (in EEA)


Marketing authorisation holder


INN


Invented name


Strength


Pharmaceutical form


Route of administration




Austria


Pharmazeutische Fabrik Montavit GesmbH
Salzbergstraße 96
6067 Absam
Austria


estradiol


Linoladiol Estradiol — Emulsion


10 mg/100 g
(0,01 %)


Vaginal emulsion


Cutaneous use, vaginal use




Austria


Pharmazeutische Fabrik Montavit GesmbH
Salzbergstraße 96
6067 Absam
Austria


estradiol


Montadiol 0,01 % Creme


10 mg/100 g
(0,01 %)


Cream


Cutaneous use, vaginal use




Bulgaria


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol


Linoladiol N


10 mg/100 g
(0,01 %)


Cream


Cutaneous use, vaginal use




Czech Republic


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol


Linoladiol N


10,33 mg/100 g
(10 mg/100 g; 0,01 %)


Cream


Cutaneous use, vaginal use




Estonia


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol


Linoladiol N


10 mg/100 g
(0,01 %)


Cream


Cutaneous use, vaginal use




Germany


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol


Linoladiol N


10 mg/100 g
(0,01 %)


Cream


Topical use




Hungary


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol


Linoladiol 0,1 mg/g gél


0,1 mg/g


Cream


Cutaneous use, vaginal use




Latvia


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol


Linoladiol N 0,1 mg/g vaginal cream


10 mg/100 g
(0,01 %)


Vaginal cream


Vaginal use, topical use




Lithuania


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol


Linoladiol N


10 mg/100 g
(0,01 %)


Cream


Cutaneous use, vaginal use




Slovak Republic


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol


Linoladiol N


10 mg/100 g
(0,01 %)


Cream


Cutaneous use




0,005
% w/w estradiol/0,4 % w/w prednisolone containing medicinal products for topical use













Member State (in EEA)


Marketing authorisation holder


INN


Invented name


Strength


Pharmaceutical form


Route of administration




Estonia


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol
prednisolone


Linoladiol HN


0,05 mg/g
4 mg/g


Cream


Cutaneous use




Germany


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol
prednisolone


Linoladiol HN


0,005 g/100 g (0,005 %)


Cream


Topical use




Latvia


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol
prednisolone


Linoladiol-HN 0,05 mg/4 mg/g cream


0,05 mg/g
4 mg/g


Cream


Cutaneous use




Lithuania


Dr. August Wolff GmbH&Co.
KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany


estradiol
prednisolone


Linoladiol HN


0,05 mg/g
4 mg/g


Cream


Cutaneous use







ANNEX II
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States










Member State EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Denmark


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Dexamed


5 mg


Tablet


Oral use




Finland


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Attentin 5 mg


5 mg


Tablet


Oral use




Ireland


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Dexamed 5 mg tablets


5 mg


Tablet


Oral use




Luxembourg


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Attentin 5 mg


5 mg


Tablet


Oral use




Norway


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Attentin


5 mg


Tablet


Oral use




Spain


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Dexamed 5 mg comprimidos


5 mg


Tablet


Oral use




Sweden


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Attentin 5 mg


5 mg


Tablet


Oral use




The Netherlands


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Tentin 5 mg


5 mg


Tablet


Oral use




United Kingdom


Kohne Pharma GmbH
Schallbruch 1
42781 Haan
Germany


Dexamed 5 mg


5 mg


Tablet


Oral use







ANNEX III
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content (concentration)




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
1020 Wien
Austria


Sandostatin LAR 10 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
1020 Wien
Austria


Sandostatin LAR 20 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
1020 Wien
Austria


Sandostatin LAR 30 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40,
1800 Vilvoorde
Belgium


Sandostatine Long Acting Repeatable


10 mg


Powder and solvent for suspension for injection


Injection


4 mg/ml




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40,
1800 Vilvoorde
Belgium


Sandostatine Long Acting Repeatable


20 mg


Powder and solvent for suspension for injection


Injection


8 mg/ml




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40,
1800 Vilvoorde
Belgium


Sandostatine Long Acting Repeatable


30 mg


Powder and solvent for suspension for injection


Injection


12 mg/ml




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25, 90429
Nuremberg
Germany


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25, 90429
Nuremberg
Germany


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Cyprus


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Injection


4 mg/ml




Cyprus


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Injection


8 mg/ml




Cyprus


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Injection


12 mg/ml




Czech Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin LAR 20 MG


20 mg


Powder and solvent for suspension for injection


Intramuscular use


10 mg/ml




Czech Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin LAR 30 MG


30 mg


Powder and solvent for suspension for injection


Intramuscular use


15 mg/ml




Denmark


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Injection


4 mg/ml




Denmark


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Injection


8 mg/ml




Denmark


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Injection


12 mg/ml




Estonia


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Intramuscular use


5 mg/ml




Estonia


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Intramuscular use


10 mg/ml




Estonia


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Intramuscular use


15 mg/ml




Finland


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Intramuscular use


5 mg/ml




Finland


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Intramuscular use


10 mg/ml




Finland


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Intramuscular use


15 mg/ml




France


Novartis Pharma S.A.S.
2-4, rue Lionel Terray
92500 RUEIL-MALMAISON,
France


Sandostatine LP


10 mg


Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M)


Intramuscular use


4 mg/ml




France


Novartis Pharma S.A.S.
2-4, rue Lionel Terray
92500 RUEIL-MALMAISON,
France


Sandostatine LP


20 mg


Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M)


Intramuscular use


8 mg/ml




France


Novartis Pharma S.A.S.
2-4, rue Lionel Terray
92500 RUEIL-MALMAISON,
France


Sandostatine LP


30 mg


Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M)


Intramuscular use


12 mg/ml




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR — Monatsdepot 10 mg


10 mg/2 ml


Powder and solvent for suspension for injection


Injection


5 mg/ml




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR- Monatsdepot 20 mg


20 mg/2 ml


Powder and solvent for suspension for injection


Injection


10 mg/ml




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR- Monatsdepot 30 mg


30 mg/2 ml


Powder and solvent for suspension for injection


Injection


15 mg/ml




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
Greece


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Intramuscular use


4 mg/ml




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
Greece


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Intramuscular use


8 mg/ml




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
Greece


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Intramuscular use


12 mg/ml




Hungary


Novartis Hungária Kft.
(Pharma részlege)
Bartók Béla út 43-47
1114 Budapest
Hungary


Sandostatin LAR 10 mg por és oldószer szuszpenziós injekcióhoz


10 mg


Powder and solvent for suspension for injection


Intramuscular use


5 mg/ml




Hungary


Novartis Hungária Kft.
(Pharma részlege)
Bartók Béla út 43-47
1114 Budapest
Hungary


Sandostatin LAR 20 mg por és oldószer szuszpenziós injekcióhoz


20 mg


Powder and solvent for suspension for injection


Intramuscular use


10 mg/ml




Hungary


Novartis Hungária Kft.
(Pharma részlege)
Bartók Béla út 43-47
1114 Budapest
Hungary


Sandostatin LAR 30 mg por és oldószer szuszpenziós injekcióhoz


30 mg


Powder and solvent for suspension for injection


Intramuscular use


15 mg/ml




Iceland


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Intramuscular use


5 mg/ml




Iceland


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Intramuscular use


10 mg/ml




Iceland


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Intramuscular use


15 ml/mg




Ireland


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Injection


5 ml/mg




Ireland


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Injection


10 ml/mg




Ireland


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Injection


15 ml/mg




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
Italy


Sandostatina LAR


10 mg


Powder and solvent for suspension for injection


Injection


4 mg/ml




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
Italy


Sandostatina LAR


20 mg


Powder and solvent for suspension for injection


Injection


8 mg/ml




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
Italy


Sandostatina LAR


30 mg


Powder and solvent for suspension for injection


Injection


12 mg/ml




Latvia


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR 10 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Latvia


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR 20 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Latvia


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR 30 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Intramuscular use


5 mg/ml;
4 mg/ml




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Intramuscular use


10 mg/ml;
8 mg/ml




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Intramuscular use


15 mg/ml;
12 mg/ml




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany


Sandostatin Long Acting Repeatable


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany


Sandostatin Long Acting Repeatable


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany


Sandostatin Long Acting Repeatable


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Malta


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR 10 mg Powder and solvent for suspension for injection


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Malta


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR 20 mg Powder and solvent for suspension for injection


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Malta


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR 30 mg Powder and solvent for suspension for injection


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




The Netherlands


Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands


Sandostatine LAR 10 mg, poeder en oplosmiddel voor suspensie voor injectie


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




The Netherlands


Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands


Sandostatine LAR 20 mg, poeder en oplosmiddel voor suspensie voor injectie


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




The Netherlands


Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands


Sandostatine LAR 30 mg, poeder en oplosmiddel voor suspensie voor injectie


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Norway


Novartis Norge AS
Postboks 4284 Nydalen,
0401 Oslo
Norway


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Norway


Novartis Norge AS
Postboks 4284 Nydalen,
0401 Oslo
Norway


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Norway


Novartis Norge AS
Postboks 4284 Nydalen,
0401 Oslo
Norway


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Poland


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Poland


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Poland


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Portugal


Novartis Farma — Produtos
Farmacêuticos S.A.
Av. Professor Doutor Cavaco Silva, 10 E
Taguspark
2740-255 Porto Salvo
Portugal


Sandostatina LAR


10 mg/2 ml


Powder and solvent for suspension for injection


Intramuscular use


5 mg/ml




Portugal


Novartis Farma — Produtos
Farmacêuticos S.A.
Av. Professor Doutor Cavaco Silva, 10 E
Taguspark
2740-255 Porto Salvo
Portugal


Sandostatina LAR


20 mg/2 ml


Powder and solvent for suspension for injection


Intramuscular use


10 mg/ml




Portugal


Novartis Farma — Produtos
Farmacêuticos S.A.
Av. Professor Doutor Cavaco Silva, 10 E
Taguspark
2740-255 Porto Salvo
Portugal


Sandostatina LAR


30 mg/2 ml


Powder and solvent for suspension for injection


Intramuscular use


15 mg/ml




Romania


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR 10 mg pulbere și solvent pentru suspensie injectabilă


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Romania


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR 20 mg pulbere și solvent pentru suspensie injectabilă


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Romania


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR 30 mg pulbere și solvent pentru suspensie injectabilă


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Slovak Republic


Novartis s.r.o.
Na Pankrá ci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml
4 mg/ml




Slovak Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml
8 mg/ml




Slovak Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml
12 mg/ml




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR 10 mg prašek in vehikel za suspenzijo za injiciranje


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR 20 mg prašek in vehikel za suspenzijo za injiciranje


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin LAR 30 mg prašek in vehikel za suspenzijo za injiciranje


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts
Catalanes, 764
08013 Barcelona
Spain


Sandostatin LAR 10 mg polvo para suspensión inyectable


10 mg


Powder and solvent for suspension for injection


Intramuscular use


5 mg/ml




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts
Catalanes, 764
08013 Barcelona
Spain


Sandostatin LAR 20 mg polvo para suspensión inyectable


20 mg


Powder and solvent for suspension for injection


Intramuscular use


10 mg/ml




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts
Catalanes, 764
08013 Barcelona
Spain


Sandostatin LAR 30 mg polvo para suspensión inyectable


30 mg


Powder and solvent for suspension for injection


Intramuscular use


15 mg/ml




Sweden


Novartis Sverige AB
Kemistvägen 1B/Box 1150
183 11 Täby
Sweden


Sandostatin LAR


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




Sweden


Novartis Sverige AB
Kemistvägen 1B/Box 1150
183 11 Täby
Sweden


Sandostatin LAR


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




Sweden


Novartis Sverige AB
Kemistvägen 1B/Box 1150
183 11 Täby
Sweden


Sandostatin LAR


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml




United Kingdom


Novartis Pharmaceuticals UK
Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR 10 mg powder and solvent for suspension for injection


10 mg


Powder and solvent for suspension for injection


Injection


5 mg/ml




United Kingdom


Novartis Pharmaceuticals UK
Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR 20 mg powder and solvent for suspension for injection


20 mg


Powder and solvent for suspension for injection


Injection


10 mg/ml




United Kingdom


Novartis Pharmaceuticals UK
Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin LAR 30 mg powder and solvent for suspension for injection


30 mg


Powder and solvent for suspension for injection


Injection


15 mg/ml







ANNEX IV
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content (concentration)




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
1020 Wien
Austria


Sandostatin 0,05 mg/ml — Ampullen


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,05 mg/ml




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
1020 Wien
Austria


Sandostatin 0,1 mg/ml — Ampullen


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,1 mg/ml




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
1020 Wien
Austria


Sandostatin 0,5 mg/ml — Ampullen


0,5 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,5 mg/ml




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
1020 Wien
Austria


Sandostatin 0,2 mg/ml — Durchstechflasche


0,2 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,2 mg/ml




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40,
1800 Vilvoorde
Belgium


Sandostatine


0,1 mg/ml


Solution for injection


Injection or infusion


0,1 mg/ml




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40,
1800 Vilvoorde
Belgium


Sandostatine


0,5 mg/ml


Solution for injection


Injection or infusion


0,5 mg/ml




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25, 90429
Nuremberg
Germany


Sandostatin


0,1 mg/ml


Solution for injection


Subcutaneous use or intravenous use


0,1 mg/ml




Cyprus


Novartis Pharmaceuticals UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin


0,05 mg/ml


Solution for injection


Injection


0,05 mg/ml




Cyprus


Novartis Pharmaceuticals UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin


0,1 mg/ml


Solution for injection


Injection


0,1 mg/ml




Czech Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin 0,05 mg/ml


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use or intravenous use


0,05 mg/ml




Czech Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin 0,1 mg/ml


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use or intravenous use


0,1 mg/ml




Czech Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin 0,5 mg/ml


0,5 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use or intravenous use


0,5 mg/ml




Czech Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin 0,2 mg/ml


0,2 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use or intravenous use


0,2 mg/ml




Denmark


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,05 mg/ml




Denmark


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,1 mg/ml




Denmark


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin


1 mg/5 ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


1 mg/5 ml




Estonia


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin


0,1 mg/ml


Solution for injection


Subcutaneous use


0,1 mg/ml




Finland


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin


0,05 mg/ml


Solution for injection


Subcutaneous use or intravenous use


0,05 mg/ml




Finland


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin


0,1 mg/ml


Solution for injection


Subcutaneous use or intravenous use


0,1 mg/ml




Finland


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin


0,5 mg/ml


Solution for injection


Subcutaneous use or intravenous use


0,5 mg/ml




France


Novartis Pharma S.A.S.
2-4, rue Lionel Terray
92500 RUEIL-MALMAISON,
France


Sandostatine


0,05 mg/1ml


Solution for injection


Subcutaneous use or intravenous use


0,05 mg/ml




France


Novartis Pharma S.A.S.
2-4, rue Lionel Terray
92500 RUEIL-MALMAISON,
France


Sandostatine


0,1 mg/1ml


Solution for injection


Subcutaneous use or intravenous use


0,1 mg/ml




France


Novartis Pharma S.A.S.
2-4, rue Lionel Terray
92500 RUEIL-MALMAISON,
France


Sandostatine


0,5 mg/1ml


Solution for injection


Subcutaneous use or intravenous use


0,5 mg/ml




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 50 ug


0,05 mg/ml


Solution for injection


Injection


0,05 mg/ml




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 100 ug


0,1 mg/ml


Solution for injection


Injection


0,1 mg/ml




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 500 ug


0,5 mg/1ml


Solution for injection


Injection


0,5 mg/1ml




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 1000 ug


1 mg/5 ml


Solution for injection


Injection


1 mg/5 ml




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
Greece


Sandostatin


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use or intravenous use


0,1 mg/ml




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
Greece


Sandostatin


0,5 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use or intravenous use


0,5 mg/ml




Hungary


Novartis Hungária Kft.
(Pharma részlege)
Bartók Béla út 43-47
1114 Budapest
Hungary


Sandostatin 0,1 mg/ml oldatos injekció


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use or intravenous use


0,1 mg/ml




Hungary


Novartis Hungária Kft.
(Pharma részlege)
Bartók Béla út 43-47
1114 Budapest
Hungary


Sandostatin 0,2 mg/ml oldatos injekció


0,2 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use or intravenous use


0,2 mg/ml




Iceland


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin


50 mcg/ml


Solution for injection


Subcutaneous use or intravenous use


50 mcg/ml




Iceland


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin


100 mcg/ml


Solution for injection


Subcutaneous use or intravenous use


100 mcg/ml




Iceland


Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark


Sandostatin


200 mcg/ml


Solution for injection


Subcutaneous use or intravenous use


200 mcg/ml




Ireland


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin


50 mcg/ml


Solution for s.c. or i.v. injection


Injection or infusion


50 mcg/ml




Ireland


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin


100 mcg/ml


Solution for s.c. injection or concentrate for solution for i.v. injection


Injection or infusion


100 mcg/ml




Ireland


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin


500 mcg/ml


Solution for s.c. injection or concentrate for solution for i.v. injection or concentrate for solution for i.v. infusion


Injection or infusion


500 mcg/ml




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
Italy


Sandostatina


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,05 mg/ml




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
Italy


Sandostatina


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,1 mg/ml




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
Italy


Sandostatina


0,5 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,5 mg/ml




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
Italy


Sandostatina


1 mg/5 ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


1 mg/5 ml




Latvia


Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin 0,1 mg/ml šķīdums injekcijām


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,1 mg/ml




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
02130 Espoo
Finland


Sandostatin


0,1 mg/ml


Solution for injection


Subcutaneous use or intravenous use


0,1 mg/ml




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 50 ug


0 ,05 mg/ml


Solution for injection


Injection


0,05 mg/ml




Luxembourg


N.V. Novartis Pharma S.A.
Medialaan 40,
1800 Vilvoorde
Belgium


Sandostatine


0,1 mg/ml


Solution for injection


Injection


0,1 mg/ml




Luxembourg


N.V. Novartis Pharma S.A.
Medialaan 40,
1800 Vilvoorde
Belgium


Sandostatine


0,5 mg/ml


Solution for injection


Injection


0,5 mg/ml




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 1000 ug


1 mg/5 ml


Solution for injection


Injection


1 mg/5 ml




Malta


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin 0,5 mg/1 ml ampoules


0,5 mg/ml


Solution for injection (s.c) or concentrate for solution for infusion (i.v.infusion)


Injection or infusion


0,5 mg/ml




Malta


Novartis Pharmaceuticals
UNITED KINGDOM Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin multidose vials 1 mg/5 ml (0,2 mg/ml)


0,2 mg/ml


Solution for injection (s.c.) or concentrate for solution for infusion (i.v. infusion)


Injection or infusion


0,2 mg/ml




The Netherlands


Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands


Sandostatine 0,05 mg/ml, injectievloeistof 1 ml


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,05 mg/ml




The Netherlands


Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands


Sandostatine 0,1 mg/ml, injectievloeistof 1 ml


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,1 mg/ml




The Netherlands


Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands


Sandostatine 0,5 mg/ml, oplossing voor injectie 1 ml


0,5 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,5 mg/ml




The Netherlands


Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands


Sandostatine 0,2 mg/ml, injectievloeistof 5 ml


0,2 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,2 mg/ml




Norway


Novartis Norge AS
Postboks 4284 Nydalen,
0401 Oslo
Norway


Sandostatin


0,05 mg/ml


Solution for injection


Injection or infusion


0,05 mg/ml




Norway


Novartis Norge AS
Postboks 4284 Nydalen,
0401 Oslo
Norway


Sandostatin


0,1 mg/ml


Solution for injection


Injection or infusion


0,1 mg/ml




Norway


Novartis Norge AS
Postboks 4284 Nydalen,
0401 Oslo
Norway


Sandostatin


0,2 mg/ml


Solution for injection


Injection or infusion


0,2 mg/ml




Poland


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin


50 mcg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


50 mcg/ml




Poland


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin


100 mcg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


100 mcg/ml




Portugal


Novartis Farma — Produtos
Farmacêuticos S.A.
Av. Professor Doutor Cavaco Silva, 10 E
Taguspark
2740-255 Porto Salvo
Portugal


Sandostatina


0,05 mg/ml


Solution for injection


Subcutaneous use Intravenous use


0,05 mg/ml




Portugal


Novartis Farma — Produtos
Farmacêuticos S.A.
Av. Professor Doutor Cavaco Silva, 10 E
Taguspark
2740-255 Porto Salvo
Portugal


Sandostatina


0,1 mg/ml


Solution for injection


Subcutaneous use Intravenous use


0,1 mg/ml




Portugal


Novartis Farma — Produtos
Farmacêuticos S.A.
Av. Professor Doutor Cavaco Silva, 10 E
Taguspark
2740-255 Porto Salvo
Portugal


Sandostatina


0,5 mg/ml


Solution for injection


Subcutaneous use Intravenous use


0,5 mg/ml




Portugal


Novartis Farma — Produtos
Farmacêuticos S.A.
Avenida Professor Doutor Cavaco Silva, n.o 10E
Taguspark
2740-255 Porto Salvo
Portugal


Sandostatina


0,2 mg/ml


Solution for injection


Subcutaneous use Intravenous use


0,2 mg/ml




Romania


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


SANDOSTATIN 0,1 mg/ml soluţie injectabilă


0,1 mg/ml


Solution for injection


Subcutaneous use Intravenous use


0,1 mg/ml




Slovak Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,05 mg/ml




Slovak Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,1 mg/ml




Slovak Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — Nusle
Czech Republic


Sandostatin


0,5 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,5 mg/ml




Slovak Republic


Novartis s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 — NusleCzech Republic


Sandostatin


1 mg/5 ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


1 mg/5 ml




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 0,05 mg/ml raztopina za injiciranje/infundiranje


0,05 mg/ml


Solution for injection or infusion


Injection or infusion


0,05 mg/ml




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 0,1 mg/ml raztopina za injiciranje/infundiranje


0,1 mg/ml


Solution for injection or infusion


Injection or infusion


0,1 mg/ml




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany


Sandostatin 0,5 mg/ml raztopina za injiciranje/infundiranje


0,5 mg/ml


Solution for injection or infusion


Injection or infusion


0,5 mg/ml




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts
Catalanes, 764
08013 Barcelona
Spain


Sandostatin 50 microgramos/ml solución inyectable


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use Intravenous use


0,05 mg/ml




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts
Catalanes, 764
08013 Barcelona
Spain


Sandostatin 100 microgramos/ml solución inyectable


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use Intravenous use


0,1 mg/ml




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts
Catalanes, 764
08013 Barcelona
Spain


Sandostatin 200 microgramos/ml solución inyectable


0,2 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use Intravenous use


0,2 mg/ml




Sweden


Novartis Sverige AB
Kemistvägen 1B/Box 1150
183 11 Täby
Sweden


Sandostatin


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,05 mg/ml




Sweden


Novartis Sverige AB
Kemistvägen 1B/Box 1150
183 11 Täby
Sweden


Sandostatin


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,1 mg/ml




Sweden


Novartis Sverige AB
Kemistvägen 1B/Box 1150
183 11 Täby
Sweden


Sandostatin


0,5 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,5 mg/ml




Sweden


Novartis Sverige AB
Kemistvägen 1B/Box 1150
183 11 Täby
Sweden


Sandostatin


0,2 mg/ml


Solution for injection or concentrate for solution for infusion


Injection or infusion


0,2 mg/ml




United Kingdom


Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin ampoules 50 mcg/ml solution for injection or concentrate for solution for infusion


0,05 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use Intravenous use


0,05 mg/ml




United Kingdom


Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin ampoules 100 mcg/ml solution for injection or concentrate for solution for infusion


0,1 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use Intravenous use


0,1 mg/ml




United Kingdom


Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin ampoules 500 mcg/ml solution for injection or concentrate for solution for infusion


0,5 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use Intravenous use


0,5 mg/ml




United Kingdom


Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Sandostatin multidose vial 1 mg/5ml solution for injection or concentrate for solution for infusion


0,2 mg/ml


Solution for injection or concentrate for solution for infusion


Subcutaneous use Intravenous use


0,2 mg/ml







ANNEX V
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States










Member State in EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL 25 mg Filmtabletten


25 mg


Film-coated Tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL 100 mg Filmtabletten


100 mg


Film-coated Tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL 150 mg Filmtabletten


150 mg


Film-coated Tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL 200 mg Filmtabletten


200 mg


Film-coated Tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL 300 mg Filmtabletten


300 mg


Film-coated Tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL 4-Day Starter Pack


25 mg Filmtabletten + 100 mg
Filmtabletten + 200 mg
Filmtabletten


Film-coated Tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL XR 50 mg Retardtabletten


50 mg


Prolonged-release tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL XR 150 mg Retardtabletten


150 mg


Prolonged-release tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL XR 200 mg Retardtabletten


200 mg


Prolonged-release tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL XR 300 mg Retardtabletten


300 mg


Prolonged-release tablets


Oral use




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


SEROQUEL XR 400 mg Retardtabletten


400 mg


Prolonged-release tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


150 mg


Film-coated Tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL Starter Pack


25 mg + 100 mg


Film-coated Tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL 4-Day Starter Pack


25 mg + 100 mg + 200 mg


Film-coated Tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Cyprus


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Cyprus


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Cyprus


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Cyprus


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Cyprus


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Cyprus


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Cyprus


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Cyprus


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Czech Republic


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL PROLONG 200 mg tablety s prodlouženým uvolňováním


200 mg


Prolonged-release tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL


150 mg


Film-coated Tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL 4-Day Starter Pack


25 mg + 100 mg + 200 mg


Film-coated Tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL PROLONG


50 mg


Prolonged-release tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL PROLONG


150 mg


Prolonged-release tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL PROLONG


200 mg


Prolonged-release tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL PROLONG


300 mg


Prolonged-release tablets


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S
Denmark


SEROQUEL PROLONG


400 mg


Prolonged-release tablets


Oral use




Estonia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Estonia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Estonia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Estonia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL


150 mg


Film-coated Tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL PROLONG


50 mg


Prolonged-release tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL PROLONG


150 mg


Prolonged-release tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL PROLONG


200 mg


Prolonged-release tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL PROLONG


300 mg


Prolonged-release tablets


Oral use




Finland


AstraZeneca Oy
Luomanportti 3
02200 Espoo
Finland


SEROQUEL PROLONG


400 mg


Prolonged-release tablets


Oral use




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


XEROQUEL LP


50 mg


Prolonged-release tablets


Oral use




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


XEROQUEL LP


150 mg


Prolonged-release tablets


Oral use




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


XEROQUEL LP


200 mg


Prolonged-release tablets


Oral use




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


XEROQUEL LP


300 mg


Prolonged-release tablets


Oral use




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


XEROQUEL LP


400 mg


Prolonged-release tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL 25 mg Filmtabletten


25 mg


Film-coated Tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL 100 mg Filmtabletten


100 mg


Film-coated Tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL 200 mg Filmtabletten


200 mg


Film-coated Tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL 300 mg Filmtabletten


300 mg


Film-coated Tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL PROLONG 50 mg Retardtabletten


50 mg


Prolonged-release tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL PROLONG 150 mg Retardtabletten


150 mg


Prolonged-release tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL PROLONG 200 mg Retardtabletten


200 mg


Prolonged-release tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL PROLONG 300 mg Retardtabletten


300 mg


Prolonged-release tablets


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


SEROQUEL PROLONG 400 mg Retardtabletten


400 mg


Prolonged-release tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL


150 mg


Film-coated Tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL 3-Day Starter Pack


25 mg + 100 mg


Film-coated Tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL 4-Day Starter Pack


25 mg + 100 mg + 200 mg


Film-coated Tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi
Athens, Greece


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Hungary


AstraZeneca Kft.
1113 Budapest
Bocskai út 134-146.
Hungary


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Hungary


AstraZeneca Kft.
1113 Budapest
Bocskai út 134-146.
Hungary


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Hungary


AstraZeneca Kft.
1113 Budapest
Bocskai út 134-146.
Hungary


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Hungary


AstraZeneca Kft.
1113 Budapest
Bocskai út 134-146.
Hungary


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Hungary


AstraZeneca Kft.
1113 Budapest
Bocskai út 134-146.
Hungary


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Iceland


AstraZeneca AB
151 85 Södertälje
Sweden


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Iceland


AstraZeneca AB
151 85 Södertälje
Sweden


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Iceland


AstraZeneca AB
151 85 Södertälje
Sweden


SEROQUEL


150 mg


Film-coated Tablets


Oral use




Iceland


AstraZeneca AB
151 85 Södertälje
Sweden


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Iceland


AstraZeneca AB
151 85 Södertälje
Sweden


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Iceland


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S,
Denmark


SEROQUEL PROLONG


50 mg


Prolonged-release tablets


Oral use




Iceland


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S,
Denmark


SEROQUEL PROLONG


150 mg


Prolonged-release tablets


Oral use




Iceland


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S,
Denmark


SEROQUEL PROLONG


200 mg


Prolonged-release tablets


Oral use




Iceland


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S,
Denmark


SEROQUEL PROLONG


300 mg


Prolonged-release tablets


Oral use




Iceland


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Copenhagen S,
Denmark


SEROQUEL PROLONG


400 mg


Prolonged-release tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL 25 mg compresse rivestite con film


25 mg


Film-coated Tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL 100 mg compresse rivestite con film


100 mg


Film-coated Tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL 150 mg compresse rivestite con film


150 mg


Film-coated Tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL 200 mg compresse rivestite con film


200 mg


Film-coated Tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL 300 mg compresse rivestite con film


300 mg


Film-coated Tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL


25 mg + 100 mg
+200 mg (Confezione Starter)


Film-coated Tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL


50 mg


Prolonged-release tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL


150 mg


Prolonged-release tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL


200 mg


Prolonged-release tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL


300 mg


Prolonged-release tablets


Oral use




Italy


AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
20080 — Basiglio (Milano)
Italy


SEROQUEL


400 mg


Prolonged-release tablets


Oral use




Latvia


AstraZeneca UK Limited,
2 Kingdom Street,
London W2 6BD
United Kingdom


SEROQUEL 100 mg apvalkotās tabletes


100 mg


Film-coated tablets


Oral use




Latvia


AstraZeneca UK Limited,
2 Kingdom Street,
London W2 6BD
United Kingdom


SEROQUEL 200 mg apvalkotās tabletes


200 mg


Film-coated tablets


Oral use




Latvia


AstraZeneca UK Limited,
2 Kingdom Street,
London W2 6BD
United Kingdom


SEROQUEL XR 50 mg ilgstošās darbības apvalkotās tabletes


50 mg


Prolonged-release tablets


Oral use




Latvia


AstraZeneca UK Limited,
2 Kingdom Street,
London W2 6BD
United Kingdom


SEROQUEL XR 150 mg ilgstošās darbības apvalkotās tabletes


150 mg


Prolonged-release tablets


Oral use




Latvia


AstraZeneca UK Limited,
2 Kingdom Street,
London W2 6BD
United Kingdom


SEROQUEL XR 300 mg ilgstošās darbības apvalkotās tabletes


300 mg


Prolonged-release tablets


Oral use




Latvia


AstraZeneca UK Limited,
2 Kingdom Street,
London W2 6BD
United Kingdom


SEROQUEL XR 400 mg ilgstošās darbības apvalkotās tabletes


400 mg


Prolonged-release tablets


Oral use




Lithuania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Lithuania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Lithuania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Lithuania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Lithuania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Lithuania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Lithuania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Lithuania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


150 mg


Film-coated Tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL Starter Pack


25 mg + 100 mg


Film-coated Tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL 4-Day Starter Pack


25 mg + 100 mg + 200 mg


Film-coated Tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Malta


NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel, Belgium


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Malta


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Malta


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Malta


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Malta


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Malta


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Malta


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Malta


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL-25


25 mg


Film-coated Tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL-100


100 mg


Film-coated Tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL-150


150 mg


Film-coated Tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL-200


200 mg


Film-coated Tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL-300


300 mg


Film-coated Tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL
4-daagse startverpakking


6 x 25 mg + 3x 100 mg + 1 x 200 mg


Film-coated Tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL XR 50 mg


50 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL XR 150 mg


150 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL XR 200 mg


200 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL XR 300 mg


300 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


SEROQUEL XR 400 mg


400 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


Quetiapine XR AstraZeneca 50 mg


50 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


Quetiapine XR AstraZeneca 150 mg


150 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


Quetiapine XR AstraZeneca 200 mg


200 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


Quetiapine XR AstraZeneca 300 mg


300 mg


Prolonged-release tablets


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


Quetiapine XR AstraZeneca 400 mg


400 mg


Prolonged-release tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL


150 mg


Film-coated Tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL DEPOT


50 mg


Prolonged-release tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL DEPOT


150 mg


Prolonged-release tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL DEPOT


200 mg


Prolonged-release tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL DEPOT


300 mg


Prolonged-release tablets


Oral use




Norway


AstraZeneca AS
Postboks 6050
Etterstad
0601 OSLO, Norway


SEROQUEL DEPOT


400 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL


25 mg


Film-coated Tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL


150 mg


Film-coated Tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL


300 mg


Film-coated Tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL


25 mg +
100 mg +


Film-coated Tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL


25 mg +
100 mg +
200 mg


Film-coated Tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL SR


50 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL SR


150 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL SR


200 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL SR


300 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


SEROQUEL SR


400 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


ALZEN SR


150 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


ALZEN SR


50 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


ALZEN SR


200 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


ALZEN SR


300 mg


Prolonged-release tablets


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Queluz de Baixo
2730-097 Barcarena, Portugal


ALZEN SR


400 mg


Prolonged-release tablets


Oral use




Romania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


100 mg


Film-coated Tablets


Oral use




Romania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL


200 mg


Film-coated Tablets


Oral use




Romania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Romania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


150 mg


Prolonged-release tablets


Oral use




Romania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Romania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Romania


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Slovak Republic


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


50 mg


Prolonged-release tablets


Oral use




Slovak Republic


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


200 mg


Prolonged-release tablets


Oral use




Slovak Republic


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


300 mg


Prolonged-release tablets


Oral use




Slovak Republic


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL XR


400 mg


Prolonged-release tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL 25 mg filmsko obložene tablete


25 mg


Film-coated Tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL 100 mg filmsko obložene tablete


100 mg


Film-coated Tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL 200 mg filmsko obložene tablete


200 mg


Film-coated Tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL 300 mg filmsko obložene tablete


300 mg


Film-coated Tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL SR 50 mg tablete s podaljšanim sproščanjem


50 mg


Prolonged-release tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


Seroquel SR 150 mg tablete s podaljšanim sproščanjem


150 mg


Prolonged-release tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL SR 200 mg tablete s podaljšanim sproščanjem


200 mg


Prolonged-release tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL SR 300 mg tablete s podaljšanim sproščanjem


300 mg


Prolonged-release tablets


Oral use




Slovenia


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


SEROQUEL SR 400 mg tablete s podaljšanim sproščanjem


400 mg


Prolonged-release tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL 25 mg comprimidos recubiertos con película


25 mg


Film-coated Tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL 100 mg comprimidos recubiertos con película


100 mg


Film-coated Tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL 200 mg comprimidos recubiertos con película


200 mg


Film-coated Tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL 300 mg comprimidos recubiertos con película


300 mg


Film-coated Tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL PROLONG 50 mg
Comprimidos de liberación prolongada


50 mg


Prolonged-release tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL PROLONG 150 mg
Comprimidos de liberación prolongada


150 mg


Prolonged-release tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL PROLONG 200 mg
Comprimidos de liberación prolongada


200 mg


Prolonged-release tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL PROLONG 300 mg
Comprimidos de liberación prolongada


300 mg


Prolonged-release tablets


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache,
56 Edificio Roble
28033 Madrid, Spain


SEROQUEL PROLONG 400 mg
Comprimidos de liberación prolongada


400 mg


Prolonged-release tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel


25 mg


Film-coated Tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel


100 mg


Film-coated Tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel


150 mg


Film-coated Tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel


200 mg


Film-coated Tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel


300 mg


Film-coated Tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel Depot


50 mg


Prolonged-release tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel Depot


150 mg


Prolonged-release tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel Depot


200 mg


Prolonged-release tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel Depot


300 mg


Prolonged-release tablets


Oral use




Sweden


AstraZeneca AB
151 85 Södertälje
Sweden


Seroquel Depot


400 mg


Prolonged-release tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


25 mg


Film-coated Tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


100 mg


Film-coated Tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


150 mg


Film-coated Tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


200 mg


Film-coated Tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL


300 mg


Film-coated Tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XL


50 mg


Prolonged-release tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XL


150 mg


Prolonged-release tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XL


200 mg


Prolonged-release tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XL


300 mg


Prolonged-release tablets


Oral use




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


SEROQUEL XL


400 mg


Prolonged-release tablets


Oral use