ISSN 1725-2423
doi:10.3000/17252423.C_2010.359.eng
Official Journal
of the European Union
C 359
English edition
Information and Notices
Volume 53
31 December 2010
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ISSN 1725-2423 doi:10.3000/17252423.C_2010.359.eng |
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Official Journal of the European Union |
C 359 |
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English edition |
Information and Notices |
Volume 53 |
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Notice No |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2010/C 359/01 |
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2010/C 359/02 |
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2010/C 359/03 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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31.12.2010 |
EN |
Official Journal of the European Union |
C 359/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2010/C 359/01
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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1.9.2010 |
Brinavess |
vernakalant hydrochloride |
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EU/1/10/645/001-002 |
Concentrate for solution for infusion |
C01BG11 |
6.9.2010 |
||||||
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1.9.2010 |
Sycrest |
Asenapine |
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EU/1/10/640/001-006 |
Sublingual tablet |
N05AH05 |
6.9.2010 |
||||||
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6.9.2010 |
Rapiscan |
regadenoson |
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EU/1/10/643/001 |
Solution for injection |
C01EB21 |
8.9.2010 |
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17.9.2010 |
Ibandronic Acid Teva |
Ibandronic acid |
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EU/1/10/642/001-004 |
Film-coated tablet |
M05BA06 |
21.9.2010 |
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30.9.2010 |
Telmisartan Actavis |
telmisartan |
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EU/1/10/639/001-030 |
Tablet |
C09CA07 |
5.10.2010 |
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7.10.2010 |
Myclausen |
mycophenolate mofetil |
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EU/1/10/647/001-002 |
Film-coated tablet |
L04AA06 |
11.10.2010 |
||||||
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7.10.2010 |
Twynsta |
telmisartan/amlodipine |
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EU/1/10/648/001-028 |
Tablet |
C09DB04 |
11.10.2010 |
||||||
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28.10.2010 |
Clopidogrel HCS |
Clopidogrel |
|
EU/1/10/651/001-015 |
Film-coated tablet |
B01AC04 |
2.11.2010 |
||||||
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28.10.2010 |
Clopidogrel Teva Generics B.V. |
Clopidogrel |
|
EU/1/10/650/001-015 |
Film-coated tablet |
B01AC04 |
4.11.2010 |
||||||
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28.10.2010 |
Ruconest |
Conestat alfa |
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EU/1/10/641/001 |
Powder for solution for injection |
Pending |
4.11.2010 |
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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16.9.2010 |
Zeftera |
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20.9.2010 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||||||
|
1.9.2010 |
Altargo |
|
EU/1/07/390/001-004 |
8.9.2010 |
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1.9.2010 |
Ecalta |
|
EU/1/07/416/001-002 |
6.9.2010 |
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1.9.2010 |
Keppra |
|
EU/1/00/146/001-032 |
6.9.2010 |
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1.9.2010 |
Levitra |
|
EU/1/03/248/001-015 |
6.9.2010 |
||||||
|
1.9.2010 |
Prevenar 13 |
|
EU/1/09/590/001-006 |
6.9.2010 |
||||||
|
1.9.2010 |
Regranex |
|
EU/1/99/101/001 |
6.9.2010 |
||||||
|
1.9.2010 |
Relistor |
|
EU/1/08/463/001-003 |
6.9.2010 |
||||||
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1.9.2010 |
Vfend |
|
EU/1/02/212/001-026 |
6.9.2010 |
||||||
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1.9.2010 |
Zypadhera |
|
EU/1/08/479/001-003 |
6.9.2010 |
||||||
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6.9.2010 |
Abraxane |
|
EU/1/07/428/001 |
9.9.2010 |
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6.9.2010 |
Apidra |
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EU/1/04/285/001-036 |
9.9.2010 |
||||||
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6.9.2010 |
Cialis |
|
EU/1/02/237/001-009 |
9.9.2010 |
||||||
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6.9.2010 |
Clopidogrel Winthrop |
|
EU/1/08/465/001-020 |
9.9.2010 |
||||||
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6.9.2010 |
Cymbalta |
|
EU/1/04/296/001-009 |
8.9.2010 |
||||||
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6.9.2010 |
Dynastat |
|
EU/1/02/209/001-008 |
8.9.2010 |
||||||
|
6.9.2010 |
Emadine |
|
EU/1/98/095/001-004 |
9.9.2010 |
||||||
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6.9.2010 |
Insuman |
|
EU/1/97/030/028-195 |
9.9.2010 |
||||||
|
6.9.2010 |
Menveo |
|
EU/1/10/614/001 |
9.9.2010 |
||||||
|
6.9.2010 |
M-M-RVAXPRO |
|
EU/1/06/337/001-013 |
9.9.2010 |
||||||
|
6.9.2010 |
Onglyza |
|
EU/1/09/545/001-010 |
9.9.2010 |
||||||
|
6.9.2010 |
Oslif Breezhaler |
|
EU/1/09/586/001-010 |
9.9.2010 |
||||||
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6.9.2010 |
ProQuad |
|
EU/1/05/323/001-013 |
9.9.2010 |
||||||
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6.9.2010 |
Relistor |
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EU/1/08/463/001-011 |
8.9.2010 |
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6.9.2010 |
Renvela |
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EU/1/09/521/001-007 |
9.9.2010 |
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6.9.2010 |
Thyrogen |
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EU/1/99/122/001-002 |
9.9.2010 |
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6.9.2010 |
Vimpat |
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EU/1/08/470/001-017 |
8.9.2010 |
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6.9.2010 |
Viread |
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EU/1/01/200/001-002 |
9.9.2010 |
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6.9.2010 |
Xeristar |
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EU/1/04/297/001-008 |
8.9.2010 |
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6.9.2010 |
Xolair |
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EU/1/05/319/001-010 |
8.9.2010 |
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6.9.2010 |
Zerit |
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EU/1/96/009/001-009 |
9.9.2010 |
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6.9.2010 |
Zyprexa |
|
EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/009-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 |
8.9.2010 |
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6.9.2010 |
Zyprexa Velotab |
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EU/1/99/125/001-016 |
8.9.2010 |
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10.9.2010 |
Pandemrix |
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EU/1/08/452/001 |
14.9.2010 |
||||||
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10.9.2010 |
Siklos |
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EU/1/07/397/001 |
14.9.2010 |
||||||
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16.9.2010 |
Alimta |
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EU/1/04/290/001 |
20.9.2010 |
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16.9.2010 |
Tracleer |
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EU/1/02/220/001-006 |
20.9.2010 |
||||||
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17.9.2010 |
Xyrem |
|
EU/1/05/312/001 |
21.9.2010 |
||||||
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23.9.2010 |
Kepivance |
|
EU/1/05/314/001 |
27.9.2010 |
||||||
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23.9.2010 |
Levemir |
|
EU/1/04/278/001-011 |
27.9.2010 |
||||||
|
23.9.2010 |
Revatio |
|
EU/1/05/318/001-002 |
27.9.2010 |
||||||
|
27.9.2010 |
Caelyx |
|
EU/1/96/011/001-004 |
29.9.2010 |
||||||
|
27.9.2010 |
Panretin |
|
EU/1/00/149/001 |
29.9.2010 |
||||||
|
30.9.2010 |
Clopidogrel Apotex |
|
EU/1/09/568/001-018 |
5.10.2010 |
||||||
|
30.9.2010 |
Mepact |
|
EU/1/08/502/001 |
6.10.2010 |
||||||
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30.9.2010 |
Noxafil |
|
EU/1/05/320/001 |
5.10.2010 |
||||||
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30.9.2010 |
Rotarix |
|
EU/1/05/330/001-011 |
5.10.2010 |
||||||
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30.9.2010 |
Sprycel |
|
EU/1/06/363/001-015 |
5.10.2010 |
||||||
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30.9.2010 |
Thalidomide Celgene |
|
EU/1/08/443/001 |
5.10.2010 |
||||||
|
5.10.2010 |
APTIVUS |
|
EU/1/05/315/001-002 |
7.10.2010 |
||||||
|
5.10.2010 |
Mircera |
|
EU/1/07/400/001-024 |
7.10.2010 |
||||||
|
5.10.2010 |
Revlimid |
|
EU/1/07/391/001-004 |
7.10.2010 |
||||||
|
7.10.2010 |
Cyanokit |
|
EU/1/07/420/001-002 |
11.10.2010 |
||||||
|
7.10.2010 |
DuoTrav |
|
EU/1/06/338/001-003 |
11.10.2010 |
||||||
|
7.10.2010 |
Soliris |
|
EU/1/07/393/001 |
11.10.2010 |
||||||
|
11.10.2010 |
Retacrit |
|
EU/1/07/431/001-025 |
13.10.2010 |
||||||
|
14.10.2010 |
Alisade |
|
EU/1/08/474/001-003 |
19.10.2010 |
||||||
|
14.10.2010 |
Avamys |
|
EU/1/07/434/001-003 |
19.10.2010 |
||||||
|
14.10.2010 |
Biograstim |
|
EU/1/08/450/001-010 |
18.10.2010 |
||||||
|
14.10.2010 |
Firmagon |
|
EU/1/08/504/001-003 |
18.10.2010 |
||||||
|
14.10.2010 |
Multaq |
|
EU/1/09/591/001-004 |
18.10.2010 |
||||||
|
14.10.2010 |
Ratiograstim |
|
EU/1/08/444/001-012 |
18.10.2010 |
||||||
|
14.10.2010 |
Vidaza |
|
EU/1/08/488/001 |
18.10.2010 |
||||||
|
14.10.2010 |
Xarelto |
|
EU/1/08/472/001-010 |
18.10.2010 |
||||||
|
15.10.2010 |
Riprazo |
|
EU/1/07/409/001-020 |
19.10.2010 |
||||||
|
15.10.2010 |
Silapo |
|
EU/1/07/432/001-022 |
19.10.2010 |
||||||
|
15.10.2010 |
Sprimeo |
|
EU/1/07/407/001-020 |
19.10.2010 |
||||||
|
25.10.2010 |
Axura |
|
EU/1/02/218/001-003 EU/1/02/218/005-030 |
27.10.2010 |
||||||
|
25.10.2010 |
Azilect |
|
EU/1/04/304/001-007 |
29.10.2010 |
||||||
|
25.10.2010 |
Baraclude |
|
EU/1/06/343/001-007 |
27.10.2010 |
||||||
|
25.10.2010 |
Cerezyme |
|
EU/1/97/053/001-005 |
27.10.2010 |
||||||
|
25.10.2010 |
Champix |
|
EU/1/06/360/001-013 |
27.10.2010 |
||||||
|
25.10.2010 |
Ebixa |
|
EU/1/02/219/001-049 |
27.10.2010 |
||||||
|
25.10.2010 |
Epivir |
|
EU/1/96/015/001-005 |
27.10.2010 |
||||||
|
25.10.2010 |
Faslodex |
|
EU/1/03/269/001-002 |
27.10.2010 |
||||||
|
25.10.2010 |
Forsteo |
|
EU/1/03/247/001-002 |
27.10.2010 |
||||||
|
25.10.2010 |
Herceptin |
|
EU/1/00/145/001 |
27.10.2010 |
||||||
|
25.10.2010 |
Irbesartan/Hydrochlorothiazide Teva |
|
EU/1/09/583/001-072 |
27.10.2010 |
||||||
|
25.10.2010 |
Karvea |
|
EU/1/97/049/001-039 |
27.10.2010 |
||||||
|
25.10.2010 |
Mabthera |
|
EU/1/98/067/001-002 |
27.10.2010 |
||||||
|
25.10.2010 |
Mirapexin |
|
EU/1/97/051/001-006 EU/1/97/051/009-033 |
27.10.2010 |
||||||
|
25.10.2010 |
M-M-RVAXPRO |
|
EU/1/06/337/001-013 |
27.10.2010 |
||||||
|
25.10.2010 |
Pradaxa |
|
EU/1/08/442/001-008 |
27.10.2010 |
||||||
|
25.10.2010 |
ProQuad |
|
EU/1/05/323/001-013 |
27.10.2010 |
||||||
|
25.10.2010 |
Puregon |
|
EU/1/96/008/001-041 |
27.10.2010 |
||||||
|
25.10.2010 |
Revlimid |
|
EU/1/07/391/001-004 |
27.10.2010 |
||||||
|
25.10.2010 |
Sifrol |
|
EU/1/97/050/001-006 EU/1/97/050/009-033 |
27.10.2010 |
||||||
|
25.10.2010 |
Simponi |
|
EU/1/09/546/001-004 |
27.10.2010 |
||||||
|
25.10.2010 |
Sprimeo |
|
EU/1/07/407/001-020 |
27.10.2010 |
||||||
|
25.10.2010 |
Sprycel |
|
EU/1/06/363/001-015 |
27.10.2010 |
||||||
|
25.10.2010 |
Toviaz |
|
EU/1/07/386/001-018 |
27.10.2010 |
||||||
|
25.10.2010 |
Vantavo |
|
EU/1/09/572/001-009 |
27.10.2010 |
||||||
|
25.10.2010 |
Vasovist |
|
EU/1/05/313/001-009 |
27.10.2010 |
||||||
|
25.10.2010 |
Vimpat |
|
EU/1/08/470/001-017 |
27.10.2010 |
||||||
|
25.10.2010 |
Zonegran |
|
EU/1/04/307/001-013 |
27.10.2010 |
||||||
|
25.10.2010 |
Zostavax |
|
EU/1/06/341/001-013 |
27.10.2010 |
||||||
|
28.10.2010 |
Ambirix |
|
EU/1/02/224/001-005 |
2.11.2010 |
||||||
|
28.10.2010 |
Aprovel |
|
EU/1/97/046/001-039 |
2.11.2010 |
||||||
|
28.10.2010 |
Fertavid |
|
EU/1/09/510/001-019 |
2.11.2010 |
||||||
|
28.10.2010 |
Hycamtin |
|
EU/1/96/027/001 EU/1/96/027/003-007 |
4.11.2010 |
||||||
|
28.10.2010 |
Mimpara |
|
EU/1/04/292/001-012 |
4.11.2010 |
||||||
|
28.10.2010 |
NovoSeven |
|
EU/1/96/006/001-007 |
4.11.2010 |
||||||
|
28.10.2010 |
Olanzapine Neopharma |
|
EU/1/07/426/001-011 |
1.11.2010 |
||||||
|
28.10.2010 |
Olanzapine Teva |
|
EU/1/07/427/001-057 |
1.11.2010 |
||||||
|
28.10.2010 |
PegIntron |
|
EU/1/00/131/001-050 |
4.11.2010 |
||||||
|
28.10.2010 |
Travatan |
|
EU/1/01/199/001-002 |
4.11.2010 |
||||||
|
28.10.2010 |
ViraferonPeg |
|
EU/1/00/132/001-050 |
4.11.2010 |
||||||
|
29.10.2010 |
Mycamine |
|
EU/1/08/448/001-002 |
5.11.2010 |
— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||||||
|
6.9.2010 |
ImmunoGam |
|
EU/1/10/613/001-002 |
9.9.2010 |
||||||
|
27.9.2010 |
Enviage |
|
EU/1/07/406/001-020 |
29.9.2010 |
||||||
|
28.10.2010 |
NeoSpect |
|
EU/1/00/154/001-002 |
5.11.2010 |
— Suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||||
|
16.9.2010 |
Clopidogrel 1A Pharma |
|
EU/1/09/542/001-007 |
20.9.2010 |
||||
|
16.9.2010 |
Clopidogrel Acino |
|
EU/1/09/532/001-007 |
20.9.2010 |
||||
|
16.9.2010 |
Clopidogrel Acino Pharma |
|
EU/1/09/549/001-007 |
20.9.2010 |
||||
|
16.9.2010 |
Clopidogrel Acino Pharma GmbH |
|
EU/1/09/548/001-007 |
20.9.2010 |
||||
|
16.9.2010 |
Clopidogrel Hexal |
|
EU/1/09/534/001-007 |
20.9.2010 |
||||
|
16.9.2010 |
Clopidogrel ratiopharm |
|
EU/1/09/554/001-008 |
20.9.2010 |
||||
|
16.9.2010 |
Clopidogrel ratiopharm GmbH |
|
EU/1/09/541/001-008 |
20.9.2010 |
||||
|
16.9.2010 |
Clopidogrel Sandoz |
|
EU/1/09/547/001-007 |
20.9.2010 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): Accepted
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||||
|
6.9.2010 |
Bovilis BTV8 |
Inactivated Bluetongue virus |
|
EU/2/10/106/001-014 |
Suspension for injection |
QI02AA08(cattle) QI04AA02(sheep) |
8.9.2010 |
||||
|
16.9.2010 |
Rhiniseng |
inactivated vaccine against atrophic rhinitis in pigs |
|
EU/2/10/109/001-009 |
Suspension for injection |
QI09AB04 |
21.9.2010 |
||||
|
30.9.2010 |
Coxevac |
Inactivated Coxiella burnetii vaccine |
|
EU/2/10/110/001-002 |
Suspension for injection |
QI03AB ngi |
5.10.2010 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||||
|
1.9.2010 |
Acticam |
|
EU/2/08/088/001-004 |
6.9.2010 |
||||
|
17.9.2010 |
Porcilis AR-T DF |
|
EU/2/00/026/001-004 |
21.9.2010 |
||||
|
23.9.2010 |
Porcilis AR-T DF |
|
EU/2/00/026/001-006 |
27.9.2010 |
||||
|
30.9.2010 |
Poulvac FluFend H5N3 RG |
|
EU/2/06/060/001-002 |
13.10.2010 |
||||
|
30.9.2010 |
Prac-Tic |
|
EU/2/06/066/001-012 |
5.10.2010 |
||||
|
5.10.2010 |
Nobilis Influenza H5N2 |
|
EU/2/06/061/001-004 |
7.10.2010 |
||||
|
11.10.2010 |
Equioxx |
|
EU/2/08/083/001-005 |
13.10.2010 |
||||
|
14.10.2010 |
Cerenia |
|
EU/2/06/062/005 |
18.10.2010 |
||||
|
14.10.2010 |
Improvac |
|
EU/2/09/095/001-006 |
18.10.2010 |
||||
|
14.10.2010 |
Novem |
|
EU/2/04/042/001-002 EU/2/04/042/007-010 |
18.10.2010 |
||||
|
14.10.2010 |
Posatex |
|
EU/2/08/081/001-003 |
18.10.2010 |
||||
|
14.10.2010 |
Quadrisol |
|
EU/2/97/005/001 EU/2/97/005/005 |
18.10.2010 |
||||
|
28.10.2010 |
Trocoxil |
|
EU/2/08/084/001-005 |
4.11.2010 |
||||
|
28.10.2010 |
Zactran |
|
EU/2/08/082/001-006 |
4.11.2010 |
— Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||||
|
27.9.2010 |
Flexicam |
|
EU/2/06/058/001-003 |
29.9.2010 |
— Lift of suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||||
|
1.9.2010 |
Porcilis Pesti |
|
EU/2/99/016/001-006 |
6.9.2010 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
|
The European Medicines Agency |
|
7, Westferry Circus, |
|
Canary Wharf |
|
UK - LONDON E14 4H |
(1) OJ L 136, 30.4.2004, p. 1.
(2) OJ L 136, 30.4.2004, p. 1.
|
31.12.2010 |
EN |
Official Journal of the European Union |
C 359/17 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2010/C 359/02
— 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 |
||||
|
31.8.2010 |
PecFent |
|
These Decisions are addressed to the Member States |
3.9.2010 |
— Refusal 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 |
|
6.8.2010 |
Myderison |
See Annex I |
See Annex I |
10.8.2010 |
— 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 |
|
10.8.2010 |
Pregsure BVD and associated names |
See Annex II |
See Annex II |
11.8.2010 |
— Revocation 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 |
|
6.8.2010 |
Myderison |
See Annex I |
See Annex I |
10.8.2010 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
|
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 |
|
These Decisions are addressed to the Member States |
3.9.2010 |
|||||
|
28.10.2010 |
Ruconest |
|
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 |
|
|
Myderison |
50 mg 150 mg |
film-coated tablet |
oral use |
||
|
Germany |
|
|
Myderison |
50 mg 150 mg |
film-coated tablet |
oral use |
||
|
Hungary |
|
|
Myderison |
50 mg 150 mg |
film-coated tablet |
oral use |
||
|
Lithuania |
|
|
Myderison |
50 mg 150 mg |
film-coated tablet |
oral use |
||
|
Poland |
|
|
Myderison |
50 mg 150 mg |
film-coated tablet |
oral use |
||
|
Romania |
|
|
Myderison |
50 mg 150 mg |
film-coated tablet |
oral use |
||
|
Slovak Republic |
|
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Ocular use |
2,5 ml |
||||||
|
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 |
|
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 |
|
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 |
|
Xalatan |
50 mcg/ ml |
Eye drops, solution |
Topical use |
2,5 ml |
||||||
|
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 |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Topical use |
2,5 ml |
||||||
|
Italy |
|
Xalatan |
0,005 |
Eye drops, solution |
Topical use |
2,5 ml |
||||||
|
Latvia |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Topical use |
2,5 ml |
||||||
|
Lithuania |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Ocular use |
2,5 ml |
||||||
|
Luxembourg |
|
Xalatan |
0,005 % |
Eye drops, solution |
Ocular use |
2,5 ml |
||||||
|
Malta |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Topical use |
2,5 ml |
||||||
|
Netherlands |
|
Xalatan |
50 microgram/ml |
Eye drops, solution |
Topical use |
2,5 ml |
||||||
|
Norway |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Topical use |
2,5 ml |
||||||
|
Poland |
|
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 |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Ocular use |
2,5 ml |
||||||
|
Slovak Republic |
|
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 |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Ocular use |
2,5 ml |
||||||
|
Sweden |
|
Xalatan |
0,005 % w/v |
Eye drops, solution |
Topical use |
2,5 ml |
||||||
|
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 |
|
|
Actonel Combi D |
35 mg + 1 000 mg/880 IU |
film-coated tablets + effervescent granules |
Oral use |
||||
|
France |
|
|
Norsedcombi |
35 mg + 1 000 mg/880 IU |
film-coated tablets + effervescent granules |
Oral use |
||||
|
Germany |
|
|
Norsed plus Calcium D |
35 mg + 1 000 mg/880 IU |
film-coated tablets + effervescent granules |
Oral use |
||||
|
Ireland |
|
|
Optinate Plus Ca &D |
35 mg + 1 000 mg/880 IU |
film-coated tablets + effervescent granules |
Oral use |
||||
|
Italy |
|
|
Opticalcio D3 |
35 mg + 1 000 mg/880 IU |
film-coated tablets + effervescent granules |
Oral use |
||||
|
Sweden |
|
|
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 |
|
Atacand plus mite 8 mg/12,5 mg Tabletten |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Austria |
|
Atacand plus 16 mg/12,5 mg Tabletten |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Austria |
|
Atacand Plus 32 mg/12,5 mg Tabletten |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Austria |
|
Atacand Plus 32 mg/25 mg Tabletten |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Austria |
|
Blopress Plus 8 mg/12,5 mg - Tabletten |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Austria |
|
Blopress Plus 16 mg/12,5 mg - Tabletten |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Austria |
|
Blopress Plus 32 mg/ 12,5 mg - Tabletten |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Austria |
|
Blopress Plus 32 mg/ 25 mg - Tabletten |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Belgium |
|
Atacand Plus |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Belgium |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Belgium |
|
Atacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Belgium |
|
Atacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Cyprus |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Czech Republic |
|
Atacand Plus 16 + 12,5 mg |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Denmark |
|
Atacand Zid 8 mg/12,5 mg |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Denmark |
|
Atacand Zid 16 mg/12,5 mg |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Denmark |
|
Atacand Zid 32 mg/12,5 mg |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Denmark |
|
Atacand Zid 32 mg/25 mg |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Estonia |
|
ATACAND PLUS |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Estonia |
|
ATACAND PLUS |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Estonia |
|
ATACAND PLUS |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Finland |
|
Atacand Plus |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Finland |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Finland |
|
Atacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Finland |
|
Atacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
France |
|
Hytacand 8 mg/12,5 mg comprimé |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
France |
|
Hytacand 16 mg/12,5 mg comprimé |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
France |
|
CoKenzen 8 mg/12,5 mg comprimé |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
France |
|
CoKenzen 16 mg/12,5 mg comprimé |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Germany |
|
Atacand Plus 8/12,5 mg |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Germany |
|
Atacand Plus 16/12,5 mg |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Germany |
|
Atacand Plus 32/12,5 mg Tabletten |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Germany |
|
Atacand Plus forte 32/25 mg Tabletten |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Germany |
|
Blopress 8 mg Plus 12,5 mg Tabletten. |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Germany |
|
Blopress 16 mg Plus 12,5 mg Tabletten |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Germany |
|
Blopress 32 mg Plus 12,5 mg Tabletten |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Germany |
|
Blopress forte 32 mg Plus 25 mg Tabletten |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Greece |
|
Atacand Plus |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Greece |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Greece |
|
Atacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Greece |
|
Atacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Hungary |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Iceland |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Iceland |
|
Atacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Iceland |
|
Atacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Ireland |
|
Atacand Plus 8/12,5 mg |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Ireland |
|
Atacand Plus 16/12,5 mg |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Ireland |
|
Blopress Plus 8 mg/12,5 mg tablets |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Ireland |
|
Blopress Plus 16 mg/12,5 mg tablets |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Ireland |
|
Blopress Plus 32 mg/12,5 mg tablets |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Ireland |
|
Blopress Plus 32 mg/25 mg tablets |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Italy |
|
Ratacand Plus |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Italy |
|
Ratacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Italy |
|
Ratacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Italy |
|
Ratacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Italy |
|
Blopresid 8/12,5 mg compresse |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Italy |
|
Blopresid 16/12,5 mg compresse |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Italy |
|
Blopresid 32 mg/12,5 mg compresse |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Italy |
|
Blopresid 32 mg/25 mg compresse |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Luxembourg |
|
Atacand Plus |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Luxembourg |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Luxembourg |
|
Atacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Luxembourg |
|
Atacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Netherlands |
|
Atacand Plus 8/12,5 |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Netherlands |
|
Atacand Plus 16/12,5 |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Norway |
|
Atacand Plus Mite |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Norway |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Norway |
|
Atacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Norway |
|
Atacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Portugal |
|
Hytacand |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Portugal |
|
Hytacand 16 mg |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Portugal |
|
Hytacand |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Portugal |
|
Hytacand |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Portugal |
|
Blopress |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Portugal |
|
Blopress |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Portugal |
|
Blopress |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Portugal |
|
Blopress |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Slovak Republic |
|
Atacand Plus 16/12,5 mg |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Slovak Republic |
|
Atacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Slovak Republic |
|
Atacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Slovenia |
|
Atacand Plus 16/12,5 mg |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Atacand Plus 16 mg/12,5 mg |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Atacand Plus 32 mg/12,5 mg |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Atacand Plus Forte 32 mg/25 mg |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Blopress Plus 8/12,5 mg comprimidos |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Blopress Plus 16/12,5 mg comprimidos |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Blopress Plus 32 mg/12,5 mg comprimidos |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Blopress Forte 32 mg/25 mg comprimidos |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Parapres Plus 16 mg/12,5 mg comprimidos |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Parapres Plus 32 mg/12,5 mg comprimidos |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Spain |
|
Parapres Plus Forte 32 mg/25 mg comprimidos |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Atacand Plus |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Atacand Plus |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Atacand Plus |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Atacand Plus |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Blopress Comp |
8 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Blopress Comp |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Blopress Comp |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Blopress Comp |
32 mg/25 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Parapres Comp Forte |
16 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
Parapres Comp |
32 mg/12,5 mg |
Tablet |
Oral use |
|||||||||
|
Sweden |
|
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 |
|
Dovobet 50 microgram/0,5 mg/g gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Belgium |
|
Dovobet 50 microgram/g + 0,5 mg/g, zalf |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Bulgaria |
|
Daivobet® |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Cyprus |
|
Dovobet® 50 microgram/g + 0,5 mg/g ointment |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Czech Republic |
|
Daivobet mast |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Denmark |
|
Daivobet |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Denmark |
|
Daivobet |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Estonia |
|
DAIVOBET |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Finland |
|
Daivobet 50 mikrogram/g + 0,5 mg/g geeli |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Finland |
|
Daivobet 50/500 mikrog/g voide |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
France |
|
DAIVOBET 50 microgrammes/0,5 mg/g, gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
France |
|
DAIVOBET 50 microgrammes/0,5 mg/g, pommade |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Germany |
|
Daivobet 50 Mikrogramm/g + 0,5 mg/g Gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Germany |
|
Daivobet® 50 Mikrogramm/g + 0,5 mg/g Salbe |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Greece |
|
Dovobet 50 microgram/ 0,5 mg/g gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Greece |
|
Dovobet 50 microgram/g + 0,5 mg/g |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Hungary |
|
Daivobet ointment |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Iceland |
|
Daivobet 50 míkrógrömm/0,5 mg/g hlaup |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Iceland |
|
Daivobet 50 míkróg/g + 0,5 mg/g smyrsli |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Ireland |
|
Dovobet 50 microgram/g + 0,5 mg/g gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Ireland |
|
Dovobet 50 microgram/g + 0,5 mg/g ointment |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Italy |
|
Dovobet |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Italy |
|
Dovobet |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Latvia |
|
Daivobet® 50 μg/g + 0,5 mg/g ziede |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Lithuania |
|
Daivobet |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Luxembourg |
|
Dovobet Scalp 50 microgram/0,5 mg/g gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Luxembourg |
|
Dovobet 50 microgrammes/g + 0,5 mg/g, onguent |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Malta |
|
Daivobet® 50 micrograms/g + 0,5 mg/g ointment |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Netherlands |
|
Dovobet gel 50 microgram/0,5 mg/g gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Netherlands |
|
Dovobet zalf 50 microgram/g + 0,5 mg/g |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Norway |
|
Daivobet 50 mikrogram/g + 0,5 mg/g gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Norway |
|
Daivobet 50 mikrogram/g + 0,5 mg/g salve |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Poland |
|
DAIVOBET |
(50 μg + 0,5 mg)/g |
Ointment |
Cutaneous use |
|||||
|
Portugal |
|
Daivobet |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Portugal |
|
Daivobet |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Romania |
|
DAIVOBET® UNGUENT |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Slovenia |
|
Daivobet 50 mikrogramov/500 mikrogramov v 1 g mazilo |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Spain |
|
Daivobet 50 microgramos/g + 0,5 mg/g gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Spain |
|
Daivobet 50 microgramos/g + 0,5 mg/g pomada |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
Sweden |
|
Daivobet |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
Sweden |
|
Daivobet |
50 μg/g + 0,5 mg/g |
Ointment |
Cutaneous use |
|||||
|
United Kingdom |
|
Dovobet 50 microgram/g + 0,5 mg/g gel |
50 μg/g + 0,5 mg/g |
Gel |
Cutaneous use |
|||||
|
United Kingdom |
|
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 |
|
|
Actocalcio D3 |
35 mg + 1 000 mg/880 IU |
film-coated tablets + effervescent granules |
Oral use |
|||||
|
Spain |
|
|
Acrelcombi |
35 mg + 1 000 mg/880 IU |
film-coated tablets + effervescent granules |
Oral use |
|||||
|
Sweden |
|
|
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 |
|
Genotropin 12 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
12 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
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 |
|
Genotonorm |
1,3 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm |
5,0 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm |
5,3 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm |
12 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
0,2 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
0,4 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
0,6 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
0,8 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
1,0 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
1,2 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
1,4 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
1,6 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
1,8 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Genotonorm MiniQuick |
2,0 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin |
1,3 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin |
5 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin |
5,3 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin |
12 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
0,2 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
0,4 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
0,6 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
0,8 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
1,0 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
1,2 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
1,4 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
1,6 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
1,8 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Genotropin Miniquick |
2,0 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Finland |
|
Genotropin |
5 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Finland |
|
Genotropin |
12 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
France |
|
GENOTONORM 5 mg, poudre et solvant pour solution injectable |
5 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
France |
|
GENOTONORM 5,3 mg, poudre et solvant pour solution injectable |
5,3 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
France |
|
GENOTONORM 12 mg, poudre et solvant pour solution injectable |
12 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 0,4 mg, poudre et solvant pour solution injectable |
0,4 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 0,8 mg, poudre et solvant pour solution injectable |
0,8 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
France |
|
GENOTONORM MINIQUICK 1 mg, poudre et solvant pour solution injectable |
1 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 1,4 mg, poudre et solvant pour solution injectable |
1,4 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 1,8 mg, poudre et solvant pour solution injectable |
1,8 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
France |
|
GENOTONORM MINIQUICK 2 mg, poudre et solvant pour solution injectable |
2 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Genotropin 5 mg/ml |
5,0 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Genotropin 5,3 mg/ml |
5,3 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Genotropin 12 mg/ml |
12,0 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 0,2 mg |
0,2 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 0,4 mg |
0,4 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 0,6 mg |
0,6 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 0,8 mg |
0,8 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 1,0 mg |
1,0 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 1,2 mg |
1,2 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 1,4 mg |
1,4 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 1,6 mg |
1,6 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 1,8 mg |
1,8 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
GENOTROPIN MiniQuick 2,0 mg |
2,0 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
GENOTROPIN |
1 mg |
Powder and Solution for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
GENOTROPIN |
1,4 mg |
Powder and Solution for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
GENOTROPIN |
2 mg |
Powder and Solution for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
GENOTROPIN |
5 mg |
Powder and Solution for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
GENOTROPIN (WITH PRESERVATIVE) |
5,3 mg |
Powder and Solution for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
GENOTROPIN (WITH PRESERVATIVE) |
12 mg |
Powder and Solution for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
GENOTROPIN |
1,3 mg |
Powder and Solution for solution for injection |
Subcutaneous use |
||||||
|
Ireland |
|
GENOTROPIN 5,3 MG |
5,3 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN 12 MG |
12 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 0,2 MG |
0,2 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 0,4 MG |
0,4 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 0,6 MG |
0,6 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 0,8 MG |
0,8 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 1 MG |
1 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 1,2 MG |
1,2 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 1,4 MG |
1,4 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 1,6 MG |
1,6 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 1,8 MG |
1,8 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Ireland |
|
GENOTROPIN MINIQUICK 2 MG |
2 mg |
Powder and solvent for Solution for injection |
Subcutaneous Use |
||||||
|
Italy |
|
Genotropin |
5,3 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin |
12 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
0,2 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
0,4 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
0,6 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
0,8 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
1 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
1,2 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
1,4 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
1,6 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
1,8 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Italy |
|
Genotropin Miniquick |
2 mg |
powder and solvent for solution for injection |
subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm |
1,3 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm |
5 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm |
5,3 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm |
12 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
0,2 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
0,4 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
0,6 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
0,8 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
1 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
1,2 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
1,4 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
1,6 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
1,8 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
Genotonorm Miniquick |
2 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Netherlands |
|
Genotropin 5 mg, poeder en oplosmiddel voor oplossing voor injectie |
5 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Netherlands |
|
Genotropin 12 mg, poeder en oplosmiddel voor oplossing voor injectie |
12 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin 1,3 mg |
1,3 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin 12 mg |
12 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin 5,3 mg |
5,3 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Mixer |
5,3 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
1 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
2 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
0,2 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
0,4 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
0,6 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
0,8 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
1,2 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
1,4 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
1,6 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Miniquick |
1,8 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin Mixer |
1,3 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Genotropin |
5 mg |
powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Spain |
|
GENOTONORM KABIPEN 12 mg polvo y disolvente para solución inyectable |
12 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 0,2 mg polvo y disolvente para solución inyectable |
0,2 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 0,6 mg polvo y disolvente para solución inyectable |
0,6 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 1 mg polvo y disolvente para solución inyectable |
1 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 1,4 mg polvo y disolvente para solución inyectable |
1,4 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
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 |
|
GENOTONORM MINIQUICK 1,8 mg polvo y disolvente para solución inyectable |
1,8 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Spain |
|
GENOTONORM MINIQUICK 2 mg polvo y disolvente para solución inyectable |
2 mg |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin |
5,3 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin |
12 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin |
5 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
0,2 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
0,4 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
0,6 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
0,8 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
1 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
1,2 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
1,4 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
1,6 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
1,8 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Genotropin Mini Quick |
2 mg |
Powder and solution for injection |
Subcutaneous use |
||||||
|
United Kingdom |
|
GENOTROPIN 5,3 MG |
5,3 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN 12 MG |
12 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 0,2 MG |
0,2 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 0,4 MG |
0,4 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 0,6 MG |
0,6 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 0,8 MG |
0,8 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 1 MG |
1 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 1,2 MG |
1,2 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 1,4 MG |
1,4 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 1,6 MG |
1,6 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
United Kingdom |
|
GENOTROPIN MINIQUICK 1,8 MG |
1,8 mg |
Powder and solvent for solution for injection |
Subcutaneous Use |
||||||
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
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|
AT - Austria |
|
Octagam 100 mg/ml Infusionslösung |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
AT - Austria |
|
Octagam 50 mg/ml Infusionslösung |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
BE - Belgium |
|
Octagam 10 %, solution pour perfusion |
10 % (100 mg/ml) |
Solution for infusion |
Intravenous Use |
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|
BE - Belgium |
|
Octagam 50 mg/ml solution pour perfusion |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
BG - Bulgaria |
|
Octagam 10 % |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
CY - Cyprus |
|
OCTAGAM INFUSION 10 % |
10 % |
Solution for infusion |
Intravenous use |
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|
CY - Cyprus |
|
OCTAGAM INFUSION 5 % |
5 % |
Solution for infusion |
Intravenous use |
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|
CZ - Czech Republic |
|
OCTAGAM |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
CZ - Czech Republic |
|
OCTAGAM 10 % |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
DE - Germany |
|
Octagam 50 mg/ml |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
DE - Germany |
|
Octagam 5 % |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
DE - Germany |
|
Octagam 10 % |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
DK - Denmark |
|
Octagam |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
DK - Denmark |
|
Octagam |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
EL - Greece |
|
OCTAGAM |
5 % (W/V) |
Solution for infusion |
Intravenous Use |
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|
EL - Greece |
|
OCTAGAM |
10 % (100MG/ML) |
Solution for infusion |
Intravenous Use |
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|
ES - Spain |
|
Octagamocta 100 mg/ml solución para perfusión |
100 mg/ml |
Solution for infusion |
Intravenous use |
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|
ES - Spain |
|
Octagamocta 50 mg/ml solución para perfusión |
50 mg/ml |
Solution for infusion |
Intravenous use |
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|
ET - Estonia |
|
OCTAGAM |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
ET - Estonia |
|
OCTAGAM 10 % |
100 mg/1ml |
Solution for infusion |
Intravenous Use |
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|
FI - Finland |
|
OCTAGAM |
50 mg/ml 100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
FR - France |
|
OCTAGAM 100 mg/ml, solution pour perfusion |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
FR - France |
|
OCTAGAM 50 mg/ml, solution pour perfusion |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
HU - Hungary |
|
OCTAGAM 50 mg/ml oldatos infúzió |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
HU - Hungary |
|
OCTAGAM 100 mg/ml oldatos infúzió |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
IS - Iceland |
|
Octagam 5 % |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
IS - Iceland |
|
Octagam 10 % |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
IT - Italy |
|
OCTAGAM |
5 % |
Solution for infusion |
Intravenous Use |
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|
LT - Lithuania |
|
octagam |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
LU - Luxembourg |
|
Octagam |
5 % |
Solution for infusion |
Intravenous use |
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|
LU - Luxembourg |
|
Octagam-10 |
10 % |
Solution for infusion |
Intravenous use |
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|
LV - Latvia |
|
Octagam 50 mg/ml solution for infusion |
1 g/20 ml |
Solution for infusion |
Intravenous Use |
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|
LV - Latvia |
|
Octagam 50 mg/ml solution for infusion |
2,5 g/50 ml |
Solution for infusion |
Intravenous Use |
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|
LV - Latvia |
|
Octagam 50 mg/ml solution for infusion |
5 g/100 ml |
Solution for infusion |
Intravenous Use |
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|
LV - Latvia |
|
Octagam 50 mg/ml solution for infusion |
10 g/200 ml |
Solution for infusion |
Intravenous Use |
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|
LV - Latvia |
|
Octagam 100 mg/ml šķīdums infūzijām, 2 g/20 ml |
2 g/20 ml |
Solution for infusion |
Intravenous Use |
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|
LV - Latvia |
|
Octagam 100 mg/ml šķīdums infūzijām, 5 g/50 ml |
5 g/50 ml |
Solution for infusion |
Intravenous Use |
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|
LV - Latvia |
|
Octagam 100 mg/ml šķīdums infūzijām, 10 g/100 ml |
10 g/100 ml |
Solution for infusion |
Intravenous Use |
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|
LV - Latvia |
|
Octagam 100 mg/ml šķīdums infūzijām, 20 g/200 ml |
20 g/200 ml |
Solution for infusion |
Intravenous Use |
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|
MT - Malta |
|
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 |
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|
NL - Netherlands |
|
Octagam 10 % |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
NL - Netherlands |
|
Octagam 5 % |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
NO - Norway |
|
Octagam |
50 mg/ml |
Solution for infusion |
Intravenous Use |
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|
NO - Norway |
|
Octagam |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
PL - Poland |
|
Octagam |
2,5 g/50 ml |
Solution for infusion |
Intravenous Use |
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|
PL - Poland |
|
Octagam |
5 g/100 ml |
Solution for infusion |
Intravenous Use |
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|
PL - Poland |
|
Octagam 10 % |
20 g/200 ml |
Solution for infusion |
Intravenous Use |
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|
PL - Poland |
|
Octagam 10 % |
100 mg/ml |
Solution for infusion |
Intravenous Use |
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|
PT - Portugal |
|
Octagam |
50 mg/ml |
Solution for infusion |
Intravenous use |
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|
PT - Portugal |
|
Octagam |
100 mg/ml |
Solution for infusion |
Intravenous use |
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|
RO - Romania |
|
OCTAGAM |
50 mg/ml |
Solution for infusion |
Intravenous use |
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|
RO - Romania |
|
OCTAGAM 10 % |
100 mg/ml |
Solution for infusion |
Intravenous use |
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|
SE - Sweden |
|
Octagem |
50 mg/ml |
Solution for infusion |
Intravenous use |
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|
SE - Sweden |
|
Octagem |
100 mg/ml |
Solution for infusion |
Intravenous use |
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|
SI - Slovenia |
|
Octagam 50 mg/ml raztopina za infundiranje |
50 mg/ ml |
Solution for infusion |
Intravenous use |
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|
SI - Slovenia |
|
Octagam 100 mg/ml raztopina za infundiranje |
100 mg/ml |
Solution for infusion |
Intravenous use |
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|
SK - Slovakia |
|
Octagam |
20 ml 50 mg/ml |
Solution for infusion |
Intravenous use |
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|
SK - Slovakia |
|
Octagam |
50 ml 50 mg/ml |
Solution for infusion |
Intravenous use |
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|
SK - Slovakia |
|
Octagam |
100 ml 50 mg/ml |
Solution for infusion |
Intravenous use |
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|
SK - Slovakia |
|
Octagam |
200 ml 50 mg/ml |
Solution for infusion |
Intravenous use |
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|
SK - Slovakia |
|
Octagam 10 % |
20 ml 100 mg/ml |
Solution for infusion |
Intravenous use |
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|
SK - Slovakia |
|
Octagam 10 % |
50 ml 100 mg/ml |
Solution for infusion |
Intravenous use |
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|
SK - Slovakia |
|
Octagam 10 % |
100 ml 100 mg/ml |
Solution for infusion |
Intravenous use |
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|
SK - Slovakia |
|
Octagam 10 % |
200 ml 100 mg/ml |
Solution for infusion |
Intravenous use |
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|
UK - United Kingdom |
|
Octagam Infusion |
5 % w/v |
Solution for infusion |
Intravenous use |
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|
UK - United Kingdom |
|
Octagam 10 % solution for Infusion |
10 % w/v |
Solution for infusion |
Intravenous use |