Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2010-12-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, pharmaceutical industry, pharmaceutical legislation








C_2010359EN.01001801.xml










31.12.2010   


EN


Official Journal of the European Union


C 359/18





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2010/C 359/03
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




15.10.2010


Xalatan and associated names


See Annex III


See Annex III


18.10.2010




5.10.2010


Norsed Combi D and associated names


See Annex IV


See Annex IV


6.10.2010




16.9.2010


Atacand Plus and associated names


See Annex V


See Annex V


20.9.2010




30.9.2010


Daivobet


See Annex VI


See Annex VI


4.10.2010




5.10.2010


Fortipan Combi D and associated names


See Annex VII


See Annex VII


6.10.2010




1.9.2010


Brinavess







Merck Sharp & Dohme Limited,




Hertford Road,




Hodderson,




Hertfordshire EN11 9BU,




United Kingdom






These Decisions are addressed to the Member States


3.9.2010




28.10.2010


Ruconest







Pharming Group N.V.,




Darwinweg 24,




NL-2333 CR Leiden,




Nederland






These Decisions are addressed to the Member States


4.11.2010







—   Refusal of modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




1.9.2010


Genotropin


See Annex VIII


See Annex VIII


2.9.2010







—   Suspension of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




7.10.2010


Pregsure BVD and associated names


See Annex IX


See Annex IX


8.10.2010




4.10.2010


Octagam


See Annex X


See Annex X


5.10.2010






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Czech Republic


 







Meditop Pharmaceutical Co. Ltd.




Ady Endre u. 1. Pilisborosjenő 2097 Hungary






Myderison


50 mg
150 mg


film-coated tablet


oral use




Germany


 







Meditop Pharmaceutical Co. Ltd.




Ady Endre u. 1. Pilisborosjenő 2097 Hungary






Myderison


50 mg
150 mg


film-coated tablet


oral use




Hungary







Meditop Pharmaceutical Co. Ltd.




Ady Endre u. 1. Pilisborosjenő 2097 Hungary






 


Myderison


50 mg
150 mg


film-coated tablet


oral use




Lithuania


 







Meditop Pharmaceutical Co. Ltd.




Ady Endre u. 1. Pilisborosjenő 2097 Hungary






Myderison


50 mg
150 mg


film-coated tablet


oral use




Poland


 







Meditop Pharmaceutical Co. Ltd.




Ady Endre u. 1. Pilisborosjenő 2097 Hungary






Myderison


50 mg
150 mg


film-coated tablet


oral use




Romania


 







Meditop Pharmaceutical Co. Ltd.




Ady Endre u. 1. Pilisborosjenő 2097 Hungary






Myderison


50 mg
150 mg


film-coated tablet


oral use




Slovak Republic


 







Meditop Pharmaceutical Co. Ltd.




Ady Endre u. 1. Pilisborosjenő 2097 Hungary






Myderison


50 mg
150 mg


film-coated tablet


oral use







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State


Marketing Authorisation Holder


Product name


Pharmaceutical form


Strength


Target animal species


Route of administration




Belgium







Pfizer Animal Health




Rue Laid Burniat 1




1348 - Louvain-la-Neuve




BELGIUM






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Bulgaria







Pfizer Animal Health MA EEIG




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






PregSure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Czech Republic







Pfizer, spol. s r.o.




Stroupežnického 17




150 00 Praha




CZECH REPUBLIC






PregSure BVD injekční emulze


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Estonia







Pfizer Animal Health




Rue Laid Burniat 1




1348 - Louvain-la-Neuve




BELGIUM






PregSure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




France







PFIZER




23/25 Avenue du Docteur Lannelongue




75014 Paris




FRANCE






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Germany







Pfizer GmbH




Linkstraße 10




D-10785 Berlin




GERMANY






PregSure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Greece







PFIZER HELLAS S.A




243 Messogeion Ave.




Neo Psychiko




GR-154 51




GREECE






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Hungary







Pfizer Kft.




Alkotas u 53




MOM Park ‘F’ Épület




Budapest H-1123




HUNGARY






PregSure BVD vakcina A.U.V.


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Ireland







Pfizer Healthcare Ireland trading as Pfizer Animal Health




Ringaskiddy




County Cork




IRELAND






PregSure BVD Emulsion for Injection


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Italy







Pfizer Italia Srl




Via Isonzo 71




04100 – Latina




ITALY






Pregsure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Lithuania







Pfizer Animal Health S.A.




Rue Laid Burniat 1




B-1348 - Louvain-la-Neuve




BELGIUM






PREGSURE BVD, injekcinė emulsija


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Latvia







Pfizer Ltd




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






PregSure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Poland







Pfizer Trading Polska Sp. z o.o.




ul. Rzymowskiego 34




02-697 Warszawa




POLAND






PregSure BVD emulsja do wstrzykiwań


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Portugal







Laboratórios Pfizer Lda




Lagoas Park – Edifício 10




2740-244 Porto Salvo




PORTUGAL






Pregsure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Romania







Pfizer Animal Health MA EEIG




Ramsgate Road, Sandwich, Kent




CT 13 9NJ




UNITED KINGDOM






Pregsure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Slovenia







Pfizer Luxembourg SARL




Gran Duchy of Luxembourg




51, Avenue J.F. Kennedy




L-1855 - Luxembourg






Pregsure BVD emulzija za injiciranje


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Slovak republic







Pfizer Luxembourg SARL o.z.




Pfizer AH




Pribinova 25




81109 Bratislava




SLOVAK REPUBLIC






Pregsure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Spain







Pfizer SA




Avda. De Europa, 20 B




Parque Empresarial la Moraleja (Alcobendas)




28108




SPAIN






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




The Netherlands







Pfizer Animal Health BV




Rivium Westlaan 142




2909 LD Capelle a/d Ijssel




P.O. Box 37




2900 AA Capelle a/d Ijssel




THE NETHERLANDS






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




United Kingdom







Pfizer Ltd




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






Pregsure BVD Emulsion for Injection


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous







ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, 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




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstrasse 1




A - 1210 Wien, Austria






Xalatan


0,005 % w/v


Eye drops, solution


Ocular use


2,5 ml




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels, Belgium






Xalatan


0,005 %


Eye drops, solution


Ocular use


2,5 ml




Bulgaria


Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F. Kennedy, L-1855 Luxembourg, G. D. of Luxembourg


Xalatan


50 micrograms/ ml


Eye drops, solution


Topical use


2,5 ml




Czech Republic


Pfizer. s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic


Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Denmark


Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark


Xalatan


50 microg/ ml


Eye drops, solution


Topical use


2,5 ml




Estonia







Pfizer Enterprises SARL




51, Avenue J.F. Kennedy




Rond-Point du Kirchberg




L-1855 Luxembourg






Xalatan


50 micrograms / ml


Eye drops, solution


Ocular use


2,5 ml




Finland


Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland


Xalatan


50 microg/ml


Eye drops, solution


Topical use


2,5 ml




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75014 Paris




France






Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Germany


Pharmacia GmbH Linkstraße 10 10785 Berlin, Germany


Xalatan


0,005 % w/v


Eye drops, solution


Ocular use


2,5 ml




Germany


Pharmacia GmbH, Linkstraße 10 10785 Berlin, Germany


Latanoprost Pharmacia & Upjohn


0,005 % w/v


Eye drops, solution


Ocular use


2,5 ml




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Xalatan


50 mcg/ ml


Eye drops, solution


Topical use


2,5 ml




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.,




Hungary






Xalatan


0,05 mg/ml


Eye drops, solution


Topical use


2,5 ml




Iceland


Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark


Xalatan


50 microg/ ml


Eye drops, solution


Topical use


2,5 ml




Ireland







Pharmacia Ireland Limited




9 Riverwalk




National Digital Park




Citywest Business Campus




Dublin 24




Ireland






Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina - Italy






Xalatan


0,005


Eye drops, solution


Topical use


2,5 ml




Latvia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Lithuania







Pfizer Europe MA EEIG




Ramsgate Road




Sandwich, Kent CT13 9NJ




United Kingdom






Xalatan


0,005 % w/v


Eye drops, solution


Ocular use


2,5 ml




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels, Belgium






Xalatan


0,005 %


Eye drops, solution


Ocular use


2,5 ml




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Xalatan


50 microgram/ml


Eye drops, solution


Topical use


2,5 ml




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Poland







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Xalatan


0,005 % w/v


Eye drops, solution


Ocular use


2,5 ml




Portugal


Laboratorios Pfizer, Lda., Lagoas Park, Edifício 10, 2740-271 Porto Salvo, Portugal


Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Romania







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Xalatan


0,005 % w/v


Eye drops, solution


Ocular use


2,5 ml




Slovak Republic







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Slovenia


Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg, Luxembourg


Xalatan 50 mikrogramov/ml kapljice za oko, raztopina


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Xalatan


0,005 % w/v


Eye drops, solution


Ocular use


2,5 ml




Sweden







Pfizer AB




Vetenskapsvagen 10,




SE 191 90 Sollentuna




Sweden






Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml




United Kingdom







Pfizer Limited




Ramsgate Road




Sandwich, Kent




CT13 9NJ




United Kingdom






Xalatan


0,005 % w/v


Eye drops, solution


Topical use


2,5 ml







ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State EU/EEA


Marketing authorisation holder


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Bulgaria


 







Sanofi-Aventis Bulgaria EOOD




103, blvd Alexander Stamboliiski




1303 Sofia




Bulgaria






Actonel Combi D


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




France


 







Procter & Gamble Pharmaceuticals France




163-165 Quai Aulagnier




92600 Asnières-sur-Seine




France






Norsedcombi


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




Germany


 







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Strasse 2-4




64331 Weiterstadt




Germany






Norsed plus Calcium D


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




Ireland


 







Warner Chilcott UK Limited,




Old Belfast Road, Millbrook, Larne, County Antrim,




BT40 2SH




United Kingdom






Optinate Plus Ca &D


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




Italy


 







sanofi-aventis S.p.A.




viale Luigi Bodio, 37/B




20158 Milan




Italy






Opticalcio D3


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




Sweden







sanofi-aventis S.p.A.




Viale Luigi Bodio, 37/b




20158 Milano




Italy






 


Norsed Combi D


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use







ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, 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




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Atacand plus mite 8 mg/12,5 mg Tabletten


8 mg/12,5 mg


Tablet


Oral use




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Atacand plus
16 mg/12,5 mg Tabletten


16 mg/12,5 mg


Tablet


Oral use




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Atacand Plus
32 mg/12,5 mg Tabletten


32 mg/12,5 mg


Tablet


Oral use




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Atacand Plus
32 mg/25 mg Tabletten


32 mg/25 mg


Tablet


Oral use




Austria







Takeda Pharma Ges.m.b.H.,




Seidengasse 33-35,




1070 Wien,




Austria






Blopress Plus 8 mg/12,5 mg - Tabletten


8 mg/12,5 mg


Tablet


Oral use




Austria







Takeda Pharma Ges.m.b.H.,




Seidengasse 33-35,




1070 Wien,




Austria






Blopress Plus 16 mg/12,5 mg - Tabletten


16 mg/12,5 mg


Tablet


Oral use




Austria







Takeda Pharma Ges.m.b.H.,




Seidengasse 33-35,




1070 Wien,




Austria






Blopress Plus 32 mg/ 12,5 mg - Tabletten


32 mg/12,5 mg


Tablet


Oral use




Austria







Takeda Pharma Ges.m.b.H.,




Seidengasse 33-35,




1070 Wien,




Austria






Blopress Plus 32 mg/ 25 mg - Tabletten


32 mg/25 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand Plus


8 mg/12,5 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand Plus


32 mg/12,5 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand Plus


32 mg/25 mg


Tablet


Oral use




Cyprus







AstraZeneca AB, S-151 85 Södertälje,




Sweden






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Czech Republic







AstraZeneca UK Ltd.,




Macclesfield,




Cheshire,




United Kingdom






Atacand Plus
16 + 12,5 mg


16 mg/12,5 mg


Tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




DK-2620 Albertslund,




Denmark






Atacand Zid
8 mg/12,5 mg


8 mg/12,5 mg


Tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




DK-2620 Albertslund,




Denmark






Atacand Zid 16 mg/12,5 mg


16 mg/12,5 mg


Tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




DK-2620 Albertslund,




Denmark






Atacand Zid
32 mg/12,5 mg


32 mg/12,5 mg


Tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




DK-2620 Albertslund,




Denmark






Atacand Zid
32 mg/25 mg


32 mg/25 mg


Tablet


Oral use




Estonia







AstraZeneca AB,




Strängnäsvägen 44,




S-151 85 Södertälje,




Sweden






ATACAND PLUS


16 mg/12,5 mg


Tablet


Oral use




Estonia







AstraZeneca AB,




Strängnäsvägen 44,




S-151 85 Södertälje,




Sweden






ATACAND PLUS


32 mg/12,5 mg


Tablet


Oral use




Estonia







AstraZeneca AB, Strängnäsvägen 44,




S-151 85 Södertälje,




Sweden






ATACAND PLUS


32 mg/25 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand Plus


8 mg/12,5 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand Plus


32 mg/12,5 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand Plus


32 mg/25 mg


Tablet


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-Malmaison Cedex




France






Hytacand
8 mg/12,5 mg comprimé


8 mg/12,5 mg


Tablet


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-Malmaison Cedex




France






Hytacand
16 mg/12,5 mg comprimé


16 mg/12,5 mg


Tablet


Oral use




France







Laboratoires Takeda,




11-15, quai de Dion Bouton,




92816 Puteaux Cedex,




France






CoKenzen 8 mg/12,5 mg comprimé


8 mg/12,5 mg


Tablet


Oral use




France







Laboratoires Takeda,




11-15, quai de Dion Bouton,




92816 Puteaux Cedex,




France






CoKenzen 16 mg/12,5 mg comprimé


16 mg/12,5 mg


Tablet


Oral use




Germany







AstraZeneca GmbH




22876 Wedel,




Germany






Atacand Plus 8/12,5 mg


8 mg/12,5 mg


Tablet


Oral use




Germany







AstraZeneca GmbH




22876 Wedel,




Germany






Atacand Plus 16/12,5 mg


16 mg/12,5 mg


Tablet


Oral use




Germany







AstraZeneca GmbH




22876 Wedel,




Germany






Atacand Plus 32/12,5 mg Tabletten


32 mg/12,5 mg


Tablet


Oral use




Germany







AstraZeneca GmbH




22876 Wedel,




Germany






Atacand Plus forte 32/25 mg Tabletten


32 mg/25 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH,




Viktoriaallee 3-5,




52066 Aachen,




Germany






Blopress 8 mg Plus 12,5 mg Tabletten.


8 mg/12,5 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH,




Viktoriaallee 3-5,




52066 Aachen,




Germany






Blopress 16 mg Plus 12,5 mg Tabletten


16 mg/12,5 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH,




Viktoriaallee 3-5,




52066 Aachen,




Germany






Blopress 32 mg Plus 12,5 mg Tabletten


32 mg/12,5 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH,




Viktoriaallee 3-5,




52066 Aachen,




Germany






Blopress forte 32 mg Plus 25 mg Tabletten


32 mg/25 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astronafton




151 25 Maroussi




Greece






Atacand Plus


8 mg/12,5 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astronafton




151 25 Maroussi




Greece






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astronafton




151 25 Maroussi




Greece






Atacand Plus


32 mg/12,5 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astronafton




151 25 Maroussi




Greece






Atacand Plus


32 mg/25 mg


Tablet


Oral use




Hungary







AstraZeneca Kft.




1113 Budapest, Bocskai út 134-146




Hungary






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Iceland







AstraZeneca A/S Roskildevej 22,




DK-2620 Albertslund,




Denmark






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Iceland







AstraZeneca A/S Roskildevej 22,




DK-2620 Albertslund,




Denmark






Atacand Plus


32 mg/12,5 mg


Tablet


Oral use




Iceland







AstraZeneca A/S Roskildevej 22,




DK-2620 Albertslund,




Denmark






Atacand Plus


32 mg/25 mg


Tablet


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green,




Luton,




LU1 3LU,




United Kingdom






Atacand Plus 8/12,5 mg


8 mg/12,5 mg


Tablet


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green,




Luton,




LU1 3LU,




United Kingdom






Atacand Plus 16/12,5 mg


16 mg/12,5 mg


Tablet


Oral use




Ireland







Takeda UK Limited,




Takeda House,




Mercury Park,




Wycombe Lane,




Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom.






Blopress Plus 8 mg/12,5 mg tablets


8 mg/12,5 mg


Tablet


Oral use




Ireland







Takeda UK Limited,




Takeda House,




Mercury Park,




Wycombe Lane,




Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom.






Blopress Plus 16 mg/12,5 mg tablets


16 mg/12,5 mg


Tablet


Oral use




Ireland







Takeda UK Limited,




Takeda House,




Mercury Park,




Wycombe Lane,




Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom.






Blopress Plus 32 mg/12,5 mg tablets


32 mg/12,5 mg


Tablet


Oral use




Ireland







Takeda UK Limited,




Takeda House,




Mercury Park,




Wycombe Lane,




Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom.






Blopress Plus
32 mg/25 mg tablets


32 mg/25 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta-via F Sforza – 20080 Basiglio (MI) –




Italy






Ratacand Plus


8 mg/12,5 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta-via F Sforza – 20080 Basiglio (MI) –




Italy






Ratacand Plus


16 mg/12,5 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta-via F Sforza – 20080 Basiglio (MI) –




Italy






Ratacand Plus


32 mg/12,5 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta-via F Sforza – 20080 Basiglio (MI) –




Italy






Ratacand Plus


32 mg/25 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.,




Via Elio Vittorini, 129




00144 Roma




Italy






Blopresid 8/12,5 mg compresse


8 mg/12,5 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.,




Via Elio Vittorini, 129




00144 Roma




Italy






Blopresid 16/12,5 mg compresse


16 mg/12,5 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.,




Via Elio Vittorini, 129




00144 Roma




Italy






Blopresid 32 mg/12,5 mg compresse


32 mg/12,5 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.,




Via Elio Vittorini, 129




00144 Roma




Italy






Blopresid 32 mg/25 mg compresse


32 mg/25 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand Plus


8 mg/12,5 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand Plus


32 mg/12,5 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand Plus


32 mg/25 mg


Tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Atacand Plus 8/12,5


8 mg/12,5 mg


Tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Atacand Plus 16/12,5


16 mg/12,5 mg


Tablet


Oral use




Norway







AstraZeneca AS




Boks 200 Vinderen




NO-0319 Oslo,




Norway






Atacand Plus Mite


8 mg/12,5 mg


Tablet


Oral use




Norway







AstraZeneca AS




Boks 200 Vinderen




NO-0319 Oslo,




Norway






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Norway







AstraZeneca AS




Boks 200 Vinderen




NO-0319 Oslo,




Norway






Atacand Plus


32 mg/12,5 mg


Tablet


Oral use




Norway







AstraZeneca AS




Boks 200 Vinderen




NO-0319 Oslo,




Norway






Atacand Plus


32 mg/25 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Queluz de Baixo 2730-097 Barcarena,




Portugal






Hytacand


8 mg/12,5 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Queluz de Baixo 2730-097 Barcarena,




Portugal






Hytacand 16 mg


16 mg/12,5 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Queluz de Baixo 2730-097 Barcarena,




Portugal






Hytacand


32 mg/12,5 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Queluz de Baixo 2730-097 Barcarena,




Portugal






Hytacand


32 mg/25 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena,




Portugal






Blopress


8 mg/12,5 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena,




Portugal






Blopress


16 mg/12,5 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena,




Portugal






Blopress


32 mg/12,5 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena,




Portugal






Blopress


32 mg/25 mg


Tablet


Oral use




Slovak Republic







AstraZeneca AB, S-151 85 Södertälje,




Sweden






Atacand Plus 16/12,5 mg


16 mg/12,5 mg


Tablet


Oral use




Slovak Republic







AstraZeneca AB, S-151 85 Södertälje,




Sweden






Atacand Plus


32 mg/12,5 mg


Tablet


Oral use




Slovak Republic







AstraZeneca AB, S-151 85 Södertälje,




Sweden






Atacand Plus


32 mg/25 mg


Tablet


Oral use




Slovenia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Atacand Plus 16/12,5 mg


16 mg/12,5 mg


Tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/ Serrano Galvache 56




28033 Madrid,




Spain






Atacand Plus 16 mg/12,5 mg


16 mg/12,5 mg


Tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/ Serrano Galvache 56




28033 Madrid,




Spain






Atacand Plus
32 mg/12,5 mg


32 mg/12,5 mg


Tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/ Serrano Galvache 56




28033 Madrid,




Spain






Atacand Plus Forte
32 mg/25 mg


32 mg/25 mg


Tablet


Oral use




Spain







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Blopress Plus 8/12,5 mg comprimidos


8 mg/12,5 mg


Tablet


Oral use




Spain







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Blopress Plus 16/12,5 mg comprimidos


16 mg/12,5 mg


Tablet


Oral use




Spain







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Blopress Plus 32 mg/12,5 mg comprimidos


32 mg/12,5 mg


Tablet


Oral use




Spain







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Blopress Forte 32 mg/25 mg comprimidos


32 mg/25 mg


Tablet


Oral use




Spain







Almirall S.A.,




Ronda General Mitre,




151 08022 Barcelona,




Spain






Parapres Plus 16 mg/12,5 mg comprimidos


16 mg/12,5 mg


Tablet


Oral use




Spain







Almirall S.A.,




Ronda General Mitre,




151 08022 Barcelona,




Spain






Parapres Plus 32 mg/12,5 mg comprimidos


32 mg/12,5 mg


Tablet


Oral use




Spain







Almirall S.A.,




Ronda General Mitre,




151 08022 Barcelona,




Spain






Parapres Plus Forte 32 mg/25 mg comprimidos


32 mg/25 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje,




Sweden






Atacand Plus


8 mg/12,5 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje,




Sweden






Atacand Plus


16 mg/12,5 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje,




Sweden






Atacand Plus


32 mg/12,5 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje,




Sweden






Atacand Plus


32 mg/25 mg


Tablet


Oral use




Sweden







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Blopress Comp


8 mg/12,5 mg


Tablet


Oral use




Sweden







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Blopress Comp


16 mg/12,5 mg


Tablet


Oral use




Sweden







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Blopress Comp


32 mg/12,5 mg


Tablet


Oral use




Sweden







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Blopress Comp


32 mg/25 mg


Tablet


Oral use




Sweden







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Parapres Comp Forte


16 mg/12,5 mg


Tablet


Oral use




Sweden







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Parapres Comp


32 mg/12,5 mg


Tablet


Oral use




Sweden







Takeda Global Research and Development Centre (Europe) Ltd,




61 Aldwych,




London,




WC2B 4AE,




United Kingdom






Parapres Comp


32 mg/25 mg


Tablet


Oral use







ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Belgium







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet 50 microgram/0,5 mg/g gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Belgium







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet 50 microgram/g + 0,5 mg/g, zalf


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Bulgaria







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet®


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Cyprus







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet® 50 microgram/g + 0,5 mg/g ointment


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Czech Republic







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet mast


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Denmark







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Denmark







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Estonia







LEO Pharmaceutical Products




Industriparken 55




DK-2750 Ballerup




Denmark






DAIVOBET


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Finland







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50 mikrogram/g + 0,5 mg/g geeli


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Finland







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50/500 mikrog/g voide


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




France







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






DAIVOBET 50 microgrammes/0,5 mg/g, gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




France







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






DAIVOBET 50 microgrammes/0,5 mg/g, pommade


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Germany







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50 Mikrogramm/g + 0,5 mg/g Gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Germany







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet® 50 Mikrogramm/g + 0,5 mg/g Salbe


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Greece







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet 50 microgram/ 0,5 mg/g gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Greece







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet 50 microgram/g + 0,5 mg/g


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Hungary







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet ointment


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Iceland







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50 míkrógrömm/0,5 mg/g hlaup


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Iceland







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50 míkróg/g + 0,5 mg/g smyrsli


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Ireland







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet 50 microgram/g + 0,5 mg/g gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Ireland







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet 50 microgram/g + 0,5 mg/g ointment


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Italy







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Italy







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Latvia







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet® 50 μg/g + 0,5 mg/g ziede


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Lithuania







LEO Pharmaceutical Products




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Luxembourg







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet Scalp 50 microgram/0,5 mg/g gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Luxembourg







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet 50 microgrammes/g + 0,5 mg/g, onguent


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Malta







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet® 50 micrograms/g + 0,5 mg/g ointment


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Netherlands







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet gel 50 microgram/0,5 mg/g gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Netherlands







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet zalf 50 microgram/g + 0,5 mg/g


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Norway







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50 mikrogram/g + 0,5 mg/g gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Norway







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50 mikrogram/g + 0,5 mg/g salve


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Poland







LEO Pharmaceutical Products Ltd. A/S




Industriparken 55




DK-2750 Ballerup




Denmark






DAIVOBET


(50 μg + 0,5 mg)/g


Ointment


Cutaneous use




Portugal







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Portugal







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Romania







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






DAIVOBET® UNGUENT


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Slovenia







Pharmagan, d.o.o.




Vodopivceva 9




SI-4000 Kranj




Slovenia






Daivobet 50 mikrogramov/500 mikrogramov v 1 g mazilo


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Spain







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50 microgramos/g + 0,5 mg/g gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Spain







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet 50 microgramos/g + 0,5 mg/g pomada


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




Sweden







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




Sweden







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Daivobet


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use




United Kingdom







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet 50 microgram/g + 0,5 mg/g gel


50 μg/g + 0,5 mg/g


Gel


Cutaneous use




United Kingdom







LEO Pharmaceutical Products Ltd. A/S




(LEO Pharma A/S)




Industriparken 55




DK-2750 Ballerup




Denmark






Dovobet® 50 microgram/g + 0,5 mg/g ointment


50 μg/g + 0,5 mg/g


Ointment


Cutaneous use







ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing authorisation holder


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Italy


 







Warner Chilcott UK Limited,




Old Belfast Road, Millbrook, Larne, County Antrim,




BT40 2SH




United Kingdom






Actocalcio D3


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




Spain







PROCTER AND GAMBLE PHARMACEUTICALS IBERIA, S.L.




WTC Almeda Park, Ed. 1, 2a pl.




Plaça de la Pau s/n




08940 Cornellà de Llobregat (Barcelona)




Spain






 


Acrelcombi


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




Sweden







Warner Chilcott UK Limited,




Old Belfast Road, Millbrook, Larne, County Antrim,




BT40 2SH




United Kingdom






 


Fortipan Combi D


35 mg +
1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use







ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria







Pfizer Corporation Austria GmbH




Floridsdorfer Hauptstraße 1




A-1210 Wien




Austria






Genotropin 12 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


12 mg


Powder and solvent for solution for injection


Subcutaneous use




Austria







Pfizer Corporation Austria




GmbH




Floridsdorfer Hauptstraße 1




A-1210 Wien




Austria






Genotropin 5,3 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




Austria







Pfizer Corpoation Austria




GmbH




Floridsdorfer Hauptstraße 1




A-1210 Wien




Austria






Genotropin MiniQuick 0,2 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


0,2 mg


Powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm


1,3 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm


5,0 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm


5,3 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm


12 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


0,2 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


0,4 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


0,6 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


0,8 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


1,0 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


1,2 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


1,4 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


1,6 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


1,8 mg


powder and solvent for solution for injection


Subcutaneous use




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels




Belgium






Genotonorm MiniQuick


2,0 mg


powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin


1,3 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin


5 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin


12 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


0,2 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


0,4 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


0,6 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


0,8 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,0 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,2 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,4 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,6 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,8 mg


Powder and solvent for solution for injection


Subcutaneous use




Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


2,0 mg


Powder and solvent for solution for injection


Subcutaneous use




Finland







Pfizer Oy,




Tietokuja 4,




00330 Helsinki,




Finland






Genotropin


5 mg


Powder and solvent for solution for injection


Subcutaneous use




Finland







Pfizer Oy,




Tietokuja 4,




00330 Helsinki,




Finland






Genotropin


12 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM 5 mg, poudre et solvant pour solution injectable


5 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM 5,3 mg, poudre et solvant pour solution injectable


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM 12 mg, poudre et solvant pour solution injectable


12 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 0,2 mg, poudre et solvant pour solution injectable


0,2 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 0,4 mg, poudre et solvant pour solution injectable


0,4 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 0,6 mg, poudre et solvant pour solution injectable


0,6 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 0,8 mg, poudre et solvant pour solution injectable


0,8 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 1 mg, poudre et solvant pour solution injectable


1 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 1,2 mg, poudre et solvant pour solution injectable


1,2 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 1,4 mg, poudre et solvant pour solution injectable


1,4 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 1,6 mg, poudre et solvant pour solution injectable


1,6 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 1,8 mg, poudre et solvant pour solution injectable


1,8 mg


Powder and solvent for solution for injection


Subcutaneous use




France







Pfizer Holding France,




23-25 avenue du Docteur Lannelongue,




75014 Paris




France






GENOTONORM MINIQUICK 2 mg, poudre et solvant pour solution injectable


2 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






Genotropin 5 mg/ml


5,0 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






Genotropin 5,3 mg/ml


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






Genotropin 12 mg/ml


12,0 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 0,2 mg


0,2 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 0,4 mg


0,4 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 0,6 mg


0,6 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 0,8 mg


0,8 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 1,0 mg


1,0 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 1,2 mg


1,2 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 1,4 mg


1,4 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 1,6 mg


1,6 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 1,8 mg


1,8 mg


Powder and solvent for solution for injection


Subcutaneous use




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




Germany






GENOTROPIN MiniQuick 2,0 mg


2,0 mg


Powder and solvent for solution for injection


Subcutaneous use




Greece







PFIZER HELLAS A.E.




MESSOGHION AVE. 243




15451 NEO PSYCHIKO




Greece






GENOTROPIN


1 mg


Powder and Solution for solution for injection


Subcutaneous use




Greece







PFIZER HELLAS A.E.




MESSOGHION AVE. 243




15451 NEO PSYCHIKO




Greece






GENOTROPIN


1,4 mg


Powder and Solution for solution for injection


Subcutaneous use




Greece







PFIZER HELLAS A.E.




MESSOGHION AVE. 243




15451 NEO PSYCHIKO




Greece






GENOTROPIN


2 mg


Powder and Solution for solution for injection


Subcutaneous use




Greece







PFIZER HELLAS A.E.




MESSOGHION AVE. 243




15451 NEO PSYCHIKO




Greece






GENOTROPIN


5 mg


Powder and Solution for solution for injection


Subcutaneous use




Greece







PFIZER HELLAS A.E.




MESSOGHION AVE. 243




15451 NEO PSYCHIKO




Greece






GENOTROPIN (WITH PRESERVATIVE)


5,3 mg


Powder and Solution for solution for injection


Subcutaneous use




Greece







PFIZER HELLAS A.E.




MESSOGHION AVE. 243




15451 NEO PSYCHIKO




Greece






GENOTROPIN (WITH PRESERVATIVE)


12 mg


Powder and Solution for solution for injection


Subcutaneous use




Greece







PFIZER HELLAS A.E.




MESSOGHION AVE. 243




15451 NEO PSYCHIKO




Greece






GENOTROPIN


1,3 mg


Powder and Solution for solution for injection


Subcutaneous use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN 5,3 MG


5,3 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN 12 MG


12 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 0,2 MG


0,2 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 0,4 MG


0,4 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 0,6 MG


0,6 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 0,8 MG


0,8 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1 MG


1 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1,2 MG


1,2 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1,4 MG


1,4 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1,6 MG


1,6 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1,8 MG


1,8 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Ireland







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 2 MG


2 mg


Powder and solvent for Solution for injection


Subcutaneous Use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin


5,3 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin


12 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


0,2 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


0,4 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


0,6 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


0,8 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1,2 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1,4 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1,6 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1,8 mg


powder and solvent for solution for injection


subcutaneous use




Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


2 mg


powder and solvent for solution for injection


subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm


1,3 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm


5 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm


5,3 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm


12 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


0,2 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


0,4 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


0,6 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


0,8 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


1 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


1,2 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


1,4 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


1,6 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


1,8 mg


powder and solvent for solution for injection


Subcutaneous use




Luxembourg







Pfizer SA




17, Boulevard de la Plaine




B-1050 Bruxelles




Belgium






Genotonorm Miniquick


2 mg


powder and solvent for solution for injection


Subcutaneous use




Netherlands







Pfizer BV




Postbus 37




2900AA Capelle aan den Ijssel




The Netherlands






Genotropin 5 mg, poeder en oplosmiddel voor oplossing voor injectie


5 mg


powder and solvent for solution for injection


Subcutaneous use




Netherlands







Pfizer BV




Postbus 37




2900AA Capelle aan den Ijssel




The Netherlands






Genotropin 12 mg, poeder en oplosmiddel voor oplossing voor injectie


12 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin 1,3 mg


1,3 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin 12 mg


12 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin 5,3 mg


5,3 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Mixer


5,3 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


2 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


0,2 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


0,4 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


0,6 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


0,8 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1,2 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1,4 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1,6 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1,8 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin Mixer


1,3 mg


powder and solvent for solution for injection


Subcutaneous use




Portugal







Laboratórios Pfizer, Lda.




Lagoas Park,




Edifício 10




2740-271 Porto Salvo




Portugal






Genotropin


5 mg


powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM KABIPEN 12 mg polvo y disolvente para solución inyectable


12 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM KABIPEN 5,3 mg polvo y disolvente para solución inyectable


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 0,2 mg polvo y disolvente para solución inyectable


0,2 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 0,4 mg polvo y disolvente para solución inyectable


0,4 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 0,6 mg polvo y disolvente para solución inyectable


0,6 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 0,8 mg polvo y disolvente para solución inyectable


0,8 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 1 mg polvo y disolvente para solución inyectable


1 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 1,2 mg polvo y disolvente para solución inyectable


1,2 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 1,4 mg polvo y disolvente para solución inyectable


1,4 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 1,6 mg polvo y disolvente para solución inyectable


1,6 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 1,8 mg polvo y disolvente para solución inyectable


1,8 mg


Powder and solvent for solution for injection


Subcutaneous use




Spain







PFIZER, S.A.




Avda. de Europa,




20 B. Parque Empresarial La Moraleja Alcobendas




28108 MADRID




Spain






GENOTONORM MINIQUICK 2 mg polvo y disolvente para solución inyectable


2 mg


Powder and solvent for solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin


5,3 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin


12 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin


5 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


0,2 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


0,4 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


0,6 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


0,8 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


1 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


1,2 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


1,4 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


1,6 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


1,8 mg


Powder and solution for injection


Subcutaneous use




Sweden







Pfizer AB,




191 90 Sollentuna,




Sverige




Sweden






Genotropin Mini Quick


2 mg


Powder and solution for injection


Subcutaneous use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ






GENOTROPIN 5,3 MG


5,3 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN 12 MG


12 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 0,2 MG


0,2 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 0,4 MG


0,4 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 0,6 MG


0,6 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 0,8 MG


0,8 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1 MG


1 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1,2 MG


1,2 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1,4 MG


1,4 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1,6 MG


1,6 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 1,8 MG


1,8 mg


Powder and solvent for solution for injection


Subcutaneous Use




United Kingdom







Pharmacia Laboratories Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




United Kingdom






GENOTROPIN MINIQUICK 2 MG


2 mg


Powder and solvent for solution for injection


Subcutaneous Use







ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State


Marketing Authorisation Holder


Product name


Pharmaceutical form


Strength


Target animal species


Route of administration




Belgium







Pfizer Animal Health




Rue Laid Burniat 1




1348 - Louvain-la-Neuve




BELGIUM






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Bulgaria







Pfizer Animal Health MA EEIG




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






PregSure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Czech Republic







Pfizer, spol. s r.o.




Stroupežnického 17




150 00 Praha




CZECH REPUBLIC






PregSure BVD injekční emulze


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Estonia







Pfizer Animal Health




Rue Laid Burniat 1




1348 - Louvain-la-Neuve




BELGIUM






PregSure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




France







PFIZER




23/25 Avenue du Docteur Lannelongue




75014 Paris




FRANCE






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Germany







Pfizer GmbH




Linkstraße 10




D-10785 Berlin




GERMANY






PregSure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Greece







PFIZER HELLAS S.A




243 Messogeion Ave.




Neo Psychiko




GR-154 51




GREECE






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Hungary







Pfizer Kft.




Alkotas u 53




MOM Park ‘F’ Épület




Budapest H-1123




HUNGARY






PregSure BVD vakcina A.U.V.


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Ireland







Pfizer Healthcare Ireland trading as Pfizer Animal Health




Ringaskiddy




County Cork




IRELAND






PregSure BVD Emulsion for Injection


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Italy







Pfizer Italia Srl




Via Isonzo 71




04100 – Latina




ITALY






Pregsure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Lithuania







Pfizer Animal Health S.A.




Rue Laid Burniat 1




B-1348 - Louvain-la-Neuve




BELGIUM






PREGSURE BVD, injekcinė emulsija


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Latvia







Pfizer Ltd




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






PregSure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Poland







Pfizer Trading Polska Sp. z o.o.




ul. Rzymowskiego 34




02-697 Warszawa




POLAND






PregSure BVD emulsja do wstrzykiwań


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Portugal







Laboratórios Pfizer Lda




Lagoas Park – Edifício 10




2740-244 Porto Salvo




PORTUGAL






Pregsure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Romania







Pfizer Animal Health MA EEIG




Ramsgate Road, Sandwich, Kent




CT 13 9NJ




UNITED KINGDOM






Pregsure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Slovenia







Pfizer Luxembourg SARL




Gran Duchy of Luxembourg




51, Avenue J.F. Kennedy




L-1855 - Luxembourg






Pregsure BVD emulzija za injiciranje


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Slovak republic







Pfizer Luxembourg SARL o.z.




Pfizer AH




Pribinova 25




81109 Bratislava




SLOVAK REPUBLIC






Pregsure BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




Spain







Pfizer SA




Avda. De Europa, 20 B




Parque Empresarial la Moraleja (Alcobendas)




28108




SPAIN






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




The Netherlands







Pfizer Animal Health BV




Rivium Westlaan 142




2909 LD Capelle a/d Ijssel




P.O. Box 37




2900 AA Capelle a/d Ijssel




THE NETHERLANDS






PREGSURE BVD


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous




United Kingdom







Pfizer Ltd




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






Pregsure BVD Emulsion for Injection


Emulsion for injection


to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2


Cattle at breeding age (cows and heifers)


Subcutaneous







ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM, 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




AT - Austria







Octapharma Pharmazeutika




Produktionsgesellschaft m.b.H.




Oberlaaerstraße 235




A-1100 Wien




Austria






Octagam 100 mg/ml Infusionslösung


100 mg/ml


Solution for infusion


Intravenous Use




AT - Austria







Octapharma Pharmazeutika




Produktionsgesellschaft m.b.H.




Oberlaaerstraße 235




A-1100 Wien




Austria






Octagam 50 mg/ml Infusionslösung


50 mg/ml


Solution for infusion


Intravenous Use




BE - Belgium







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam 10 %, solution pour perfusion


10 % (100 mg/ml)


Solution for infusion


Intravenous Use




BE - Belgium







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam 50 mg/ml solution pour perfusion


50 mg/ml


Solution for infusion


Intravenous Use




BG - Bulgaria







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




CY - Cyprus







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM INFUSION 10 %


10 %


Solution for infusion


Intravenous use




CY - Cyprus







Hospitec Co Ltd




5 Thessalonikis, Block B




2085 Lefkosia




Cyprus






OCTAGAM INFUSION 5 %


5 %


Solution for infusion


Intravenous use




CZ - Czech Republic







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM


50 mg/ml


Solution for infusion


Intravenous Use




CZ - Czech Republic







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM 10 %


100 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 50 mg/ml


50 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




DE - Germany







OCTAPHARMA GmbH




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




DK - Denmark







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagam


50 mg/ml


Solution for infusion


Intravenous Use




DK - Denmark







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagam


100 mg/ml


Solution for infusion


Intravenous Use




EL - Greece







Octapharma Hellas SA




George Kalbitzer




60, posidonos Ave.




166 75 Glyfada Attiki




Greece






OCTAGAM


5 % (W/V)


Solution for infusion


Intravenous Use




EL - Greece







Octapharma Hellas SA




George Kalbitzer




60, posidonos Ave.




166 75 Glyfada Attiki




Greece






OCTAGAM


10 % (100MG/ML)


Solution for infusion


Intravenous Use




ES - Spain







OCTAPHARMA, S.A.




C/ Velázquez, 150




28002 Madrid




ESPAÑA






Octagamocta 100 mg/ml solución para perfusión


100 mg/ml


Solution for infusion


Intravenous use




ES - Spain







OCTAPHARMA, S.A.




C/ Velázquez, 150




28002 Madrid




ESPAÑA






Octagamocta 50 mg/ml solución para perfusión


50 mg/ml


Solution for infusion


Intravenous use




ET - Estonia







Octapharma AB




Elersvägen 40




SE-11275 Stockholm




Sweden






OCTAGAM


50 mg/ml


Solution for infusion


Intravenous Use




ET - Estonia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM 10 %


100 mg/1ml


Solution for infusion


Intravenous Use




FI - Finland







OCTAPHARMA




Rajatorpantie 41 C




01640 Vantaa




FINLAND






OCTAGAM


50 mg/ml
100 mg/ml


Solution for infusion


Intravenous Use




FR - France







Octapharma France SAS




Laurent de Narbonne




62Bis Avenue André Morizet




F- 92100 Boulogne




Billancourt




France






OCTAGAM 100 mg/ml, solution pour perfusion


100 mg/ml


Solution for infusion


Intravenous Use




FR - France







Octapharma France SAS




Laurent de Narbonne




62Bis Avenue André Morizet




F- 92100 Boulogne




Billancourt




France






OCTAGAM 50 mg/ml, solution pour perfusion


50 mg/ml


Solution for infusion


Intravenous Use




HU - Hungary







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM 50 mg/ml oldatos infúzió


50 mg/ml


Solution for infusion


Intravenous Use




HU - Hungary







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM 100 mg/ml oldatos infúzió


100 mg/ml


Solution for infusion


Intravenous Use




IS - Iceland







Octapharma AB




Nordenflychtsvägen 55




SE-112 75 Stockholm




Sweden






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




IS - Iceland







Octapharma AB




Nordenflychtsvägen 55




SE-112 75 Stockholm




Sweden






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




IT - Italy







Octapharma Ltd




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






OCTAGAM


5 %


Solution for infusion


Intravenous Use




LT - Lithuania







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






octagam


100 mg/ml


Solution for infusion


Intravenous Use




LU - Luxembourg







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam


5 %


Solution for infusion


Intravenous use




LU - Luxembourg







OCTAPHARMA BENELUX SA




Rue de Stalle 63




1180 Bruxelles (Brussels)




Belgium






Octagam-10


10 %


Solution for infusion


Intravenous use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


1 g/20 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


2,5 g/50 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


5 g/100 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma AB




Elesvagen 40




Stockholm, S-112 75




Sweden






Octagam 50 mg/ml solution for infusion


10 g/200 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml šķīdums infūzijām, 2 g/20 ml


2 g/20 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml šķīdums infūzijām, 5 g/50 ml


5 g/50 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml šķīdums infūzijām, 10 g/100 ml


10 g/100 ml


Solution for infusion


Intravenous Use




LV - Latvia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 100 mg/ml šķīdums infūzijām, 20 g/200 ml


20 g/200 ml


Solution for infusion


Intravenous Use




MT - Malta







Octapharma (IP) Limited,




The Zenith Building,




26 Spring Gardens, Manchester M2 1AB,




United Kingdom






OCTAGAM 10 %


1ml contains: protein 100mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3mg


Solution for infusion


Intravenous use




NL - Netherlands







Octapharma GmbH




Reinhard Rettinghaus




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




NL - Netherlands







Octapharma GmbH




Reinhard Rettinghaus




Elisabeth-Selbert-Str. 11




40764 Langenfeld




Germany






Octagam 5 %


50 mg/ml


Solution for infusion


Intravenous Use




NO - Norway







Octapharma AG




Kim Björnstrup




Seidenstraße 2




CH-8853 Lachen




Switzerland






Octagam


50 mg/ml


Solution for infusion


Intravenous Use




NO - Norway







Octapharma AG




Kim Björnstrup




Seidenstraße 2




CH-8853 Lachen




Switzerland






Octagam


100 mg/ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


2,5 g/50 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


5 g/100 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


20 g/200 ml


Solution for infusion


Intravenous Use




PL - Poland







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 mg/ml


Solution for infusion


Intravenous Use




PT - Portugal







Octapharma




Produtos Farmaceuticos, Lda.




Paulo Castro




Rua da Graca, 14




P-1170-169 Lisboa




Portugal






Octagam


50 mg/ml


Solution for infusion


Intravenous use




PT - Portugal







Octapharma




Produtos Farmaceuticos, Lda.




Paulo Castro




Rua da Graca, 14




P-1170-169 Lisboa




Portugal






Octagam


100 mg/ml


Solution for infusion


Intravenous use




RO - Romania







OCTAPHARMA (IP) Ltd.




The Zenith Building 26 Spring Gardens




Manchester, M2 1AB




United Kingdom






OCTAGAM


50 mg/ml


Solution for infusion


Intravenous use




RO - Romania







OCTAPHARMA (IP) Ltd.




The Zenith Building 26 Spring Gardens




Manchester, M2 1AB




United Kingdom






OCTAGAM 10 %


100 mg/ml


Solution for infusion


Intravenous use




SE - Sweden







Octapharma AB




Olivier Clairotte




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagem


50 mg/ml


Solution for infusion


Intravenous use




SE - Sweden







Octapharma AB




Olivier Clairotte




Elersvägen 40




SE-11275 Stockholm




Sweden






Octagem


100 mg/ml


Solution for infusion


Intravenous use




SI - Slovenia







Zavod Republike Slovenije za transfuzijsko medicino




Šlajmerjeva 6




1000 Ljubljana




Slovenija






Octagam 50 mg/ml raztopina za infundiranje


50 mg/ ml


Solution for infusion


Intravenous use




SI - Slovenia







Zavod Republike Slovenije za transfuzijsko medicino




Šlajmerjeva 6




1000 Ljubljana




Slovenija






Octagam 100 mg/ml raztopina za infundiranje


100 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


20 ml 50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


50 ml 50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


100 ml 50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam


200 ml 50 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


20 ml 100 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


50 ml 100 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


100 ml 100 mg/ml


Solution for infusion


Intravenous use




SK - Slovakia







Octapharma (IP) Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 %


200 ml 100 mg/ml


Solution for infusion


Intravenous use




UK - United Kingdom







Octapharma Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam Infusion


5 % w/v


Solution for infusion


Intravenous use




UK - United Kingdom







Octapharma Limited




The Zenith Building




26 Spring Gardens




Manchester M2 1AB




United Kingdom






Octagam 10 % solution for Infusion


10 % w/v


Solution for infusion


Intravenous use