ISSN 1977-091X
Official Journal
of the European Union
C 253
English edition
Information and Notices
Volume 63
31 July 2020
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ISSN 1977-091X |
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Official Journal of the European Union |
C 253 |
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English edition |
Information and Notices |
Volume 63 |
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Contents |
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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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2020/C 253/01 |
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2020/C 253/02 |
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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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31.7.2020 |
EN |
Official Journal of the European Union |
C 253/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2020 to 30 June 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 253/01)
— Issuing of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|
18.6.2020 |
Paliperidone Janssen-Cilag International |
paliperidone |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/20/1453 |
Prolonged release suspension for injection |
N05AX13 |
19.6.2020 |
|
25.6.2020 |
Fingolimod Accord |
fingolimod |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |
EU/1/20/1450 |
Capsule, hard |
L04AA27 |
6.7.2020 |
|
25.6.2020 |
Insulin aspart Sanofi |
insulin aspart |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/20/1447 |
Solution for injection |
A10AB05 |
26.6.2020 |
|
25.6.2020 |
Reblozyl |
luspatercept |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/20/1452 |
Powder for solution for injection |
B03XA06 |
26.6.2020 |
|
26.6.2020 |
Daurismo |
glasdegib |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/20/1451 |
Film-coated tablet |
L01XX63 |
29.6.2020 |
— Modification of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Date of notification |
|
2.6.2020 |
AMGEVITA |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/16/1164 |
3.6.2020 |
|
2.6.2020 |
Aripiprazole Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/15/1009 |
14.6.2020 |
|
2.6.2020 |
Braftovi |
Pierre Fabre Médicament 45, place Abel Gance, 92100 Boulogne-Billancourt, France |
EU/1/18/1314 |
3.6.2020 |
|
2.6.2020 |
Brinavess |
Correvio 15 rue du Bicentenaire, 92800 Puteaux, France |
EU/1/10/645 |
3.6.2020 |
|
2.6.2020 |
Cinacalcet Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/15/1054 |
8.6.2020 |
|
2.6.2020 |
Clopidogrel TAD |
TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland |
EU/1/09/555 |
4.6.2020 |
|
2.6.2020 |
Constella |
Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland |
EU/1/12/801 |
3.6.2020 |
|
2.6.2020 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka |
KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/17/1263 |
4.6.2020 |
|
2.6.2020 |
Farydak |
Secura Bio Limited 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland |
EU/1/15/1023 |
8.6.2020 |
|
2.6.2020 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/1024 |
11.6.2020 |
|
2.6.2020 |
Lyrica |
Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland |
EU/1/04/279 |
3.6.2020 |
|
2.6.2020 |
Memantine Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |
EU/1/13/880 |
3.6.2020 |
|
2.6.2020 |
Multaq |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/09/591 |
3.6.2020 |
|
2.6.2020 |
Nustendi |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
EU/1/20/1424 |
3.6.2020 |
|
2.6.2020 |
Pemetrexed Lilly |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/15/1034 |
3.6.2020 |
|
2.6.2020 |
Praluent |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/15/1031 |
4.6.2020 |
|
2.6.2020 |
Pregabalin Pfizer |
Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland |
EU/1/14/916 |
3.6.2020 |
|
2.6.2020 |
Revatio |
Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland |
EU/1/05/318 |
3.6.2020 |
|
2.6.2020 |
Revlimid |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/07/391 |
3.6.2020 |
|
2.6.2020 |
Taltz |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/15/1085 |
11.6.2020 |
|
2.6.2020 |
Thalidomide Celgene |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/08/443 |
3.6.2020 |
|
2.6.2020 |
Viagra |
Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland |
EU/1/98/077 |
3.6.2020 |
|
3.6.2020 |
Carmustine Obvius |
Obvius Investment B.V. De Cuserstraat 93, 1081 CN Amsterdam, Nederland |
EU/1/18/1278 |
4.6.2020 |
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3.6.2020 |
Darzalex |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/16/1101 |
4.6.2020 |
|
3.6.2020 |
Ecalta |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/07/416 |
4.6.2020 |
|
3.6.2020 |
Imnovid |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/13/850 |
4.6.2020 |
|
3.6.2020 |
Zyllt |
KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/553 |
8.6.2020 |
|
9.6.2020 |
Cablivi |
Ablynx N.V. Technologiepark 21, 9052 Zwijnaarde, België |
EU/1/18/1305 |
11.6.2020 |
|
9.6.2020 |
Granupas |
Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland |
EU/1/13/896 |
10.6.2020 |
|
9.6.2020 |
Jakavi |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/12/773 |
10.6.2020 |
|
9.6.2020 |
Kalydeco |
Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |
EU/1/12/782 |
10.6.2020 |
|
9.6.2020 |
Kiovig |
Takeda Manufacturing Austria AG Industriestraße 67, 1221 Wien, Österreich |
EU/1/05/329 |
6.7.2020 |
|
9.6.2020 |
Qarziba |
EUSA Pharma (Netherlands) B.V. Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland |
EU/1/17/1191 |
6.7.2020 |
|
9.6.2020 |
Zoely |
Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |
EU/1/11/690 |
10.6.2020 |
|
12.6.2020 |
Buvidal |
Camurus AB Ideon Science Park, 223 70 Lund, Sverige |
EU/1/18/1336 |
15.6.2020 |
|
12.6.2020 |
Deferiprone Lipomed |
Lipomed GmbH Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland |
EU/1/18/1310 |
15.6.2020 |
|
12.6.2020 |
Duloxetine Lilly |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/14/972 |
15.6.2020 |
|
12.6.2020 |
Eviplera |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/11/737 |
15.6.2020 |
|
12.6.2020 |
Holoclar |
Holostem Terapie Avanzate S.r.l. Via Glauco Gottardi 100, Modena, MO 41125, Italia |
EU/1/14/987 |
15.6.2020 |
|
12.6.2020 |
Memantine Merz |
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland |
EU/1/12/799 |
15.6.2020 |
|
12.6.2020 |
Nilemdo |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
EU/1/20/1425 |
17.6.2020 |
|
12.6.2020 |
PHEBURANE |
Eurocept International BV Trapgans 5, 1244 RL Ankeveen, Nederland |
EU/1/13/822 |
29.6.2020 |
|
17.6.2020 |
Exforge HCT |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/569 |
18.6.2020 |
|
17.6.2020 |
Ogivri |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/18/1341 |
18.6.2020 |
|
17.6.2020 |
Ratiograstim |
ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
EU/1/08/444 |
18.6.2020 |
|
18.6.2020 |
Copalia HCT |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/575 |
19.6.2020 |
|
18.6.2020 |
Dafiro HCT |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/574 |
22.6.2020 |
|
18.6.2020 |
Hexacima |
Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France |
EU/1/13/828 |
19.6.2020 |
|
18.6.2020 |
Hexyon |
Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France |
EU/1/13/829 |
19.6.2020 |
|
18.6.2020 |
Idacio |
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |
EU/1/19/1356 |
19.6.2020 |
|
18.6.2020 |
IDELVION |
CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |
EU/1/16/1095 |
25.6.2020 |
|
18.6.2020 |
Ovaleap |
Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |
EU/1/13/871 |
19.6.2020 |
|
18.6.2020 |
PecFent |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/10/644 |
19.6.2020 |
|
18.6.2020 |
Tevagrastim |
Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
EU/1/08/445 |
19.6.2020 |
|
18.6.2020 |
Trumenba |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/17/1187 |
19.6.2020 |
|
18.6.2020 |
VPRIV |
Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland |
EU/1/10/646 |
19.6.2020 |
|
18.6.2020 |
Xagrid |
Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland |
EU/1/04/295 |
19.6.2020 |
|
19.6.2020 |
Pregabalin Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/15/1011 |
6.7.2020 |
|
19.6.2020 |
Pregabalin Sandoz GmbH |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/15/1012 |
3.7.2020 |
|
25.6.2020 |
Aflunov |
Seqirus S.r.l. Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy |
EU/1/10/658 |
29.6.2020 |
|
25.6.2020 |
Cotellic |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/15/1048 |
26.6.2020 |
|
25.6.2020 |
Dupixent |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/17/1229 |
26.6.2020 |
|
25.6.2020 |
Entresto |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/15/1058 |
29.6.2020 |
|
25.6.2020 |
Erbitux |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |
EU/1/04/281 |
29.6.2020 |
|
25.6.2020 |
Intuniv |
Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland |
EU/1/15/1040 |
26.6.2020 |
|
25.6.2020 |
Kisplyx |
Eisai GmbH Lyoner Strasse 36, 60528 Frankfurt am Main, Deutschland |
EU/1/16/1128 |
4.7.2020 |
|
25.6.2020 |
Kyprolis |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1060 |
29.6.2020 |
|
25.6.2020 |
Mysildecard |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/16/1134 |
6.7.2020 |
|
25.6.2020 |
Neofordex |
Laboratoires CTRS 63 rue de l’Est, 92100 Boulogne-Billancourt, France |
EU/1/15/1053 |
29.6.2020 |
|
25.6.2020 |
Olanzapine Apotex |
Apotex Europe B.V. Archimedesweg 2, 2333 CN, Leiden, Nederland |
EU/1/10/635 |
1.7.2020 |
|
25.6.2020 |
Sovaldi |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/13/894 |
26.6.2020 |
|
25.6.2020 |
Ultomiris |
Alexion Europe SAS 103-105 Rue Anatole France, 92300 Levallois-Perret, France |
EU/1/19/1371 |
26.6.2020 |
|
25.6.2020 |
Wakix |
Bioprojet Pharma 9 rue Rameau, 75002 Paris, France |
EU/1/15/1068 |
26.6.2020 |
|
25.6.2020 |
Zejula |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/17/1235 |
26.6.2020 |
|
26.6.2020 |
AJOVY |
Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
EU/1/19/1358 |
30.6.2020 |
|
26.6.2020 |
Aripiprazole Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/15/1029 |
30.6.2020 |
|
26.6.2020 |
Benlysta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/11/700 |
6.7.2020 |
|
26.6.2020 |
Cimzia |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/09/544 |
30.6.2020 |
|
26.6.2020 |
Copalia |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/372 |
29.6.2020 |
|
26.6.2020 |
Dafiro |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/371 |
29.6.2020 |
|
26.6.2020 |
Invokana |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/13/884 |
29.6.2020 |
|
26.6.2020 |
LIBTAYO |
Regeneron Ireland Designated Activity Company (DAC) Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland |
EU/1/19/1376 |
29.6.2020 |
|
26.6.2020 |
Pramipexole Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/08/490 |
30.6.2020 |
|
26.6.2020 |
Sivextro |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/991 |
7.7.2020 |
|
26.6.2020 |
Taltz |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/15/1085 |
30.6.2020 |
|
26.6.2020 |
Talzenna |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/19/1377 |
29.6.2020 |
— Withdrawal of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Date of notification |
|
22.6.2020 |
Zerit |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/96/009 |
25.6.2020 |
— Modification of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Date of notification |
|
5.6.2020 |
Recocam |
Bimeda Animal Health Limited 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland |
EU/2/11/133 |
9.6.2020 |
|
17.6.2020 |
Profender |
Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland |
EU/2/05/054 |
18.6.2020 |
|
17.6.2020 |
Zulvac 1 + 8 Ovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/11/120 |
19.6.2020 |
|
24.6.2020 |
Aivlosin |
ECO Animal Health Europe Limited 6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland |
EU/2/04/044 |
25.6.2020 |
|
24.6.2020 |
Mirataz |
Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland |
EU/2/19/247 |
25.6.2020 |
|
24.6.2020 |
UpCard |
Vétoquinol SA Magny-Vernois, 70200 Lure, France |
EU/2/15/184 |
1.7.2020 |
|
24.6.2020 |
Zulvac BTV |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/17/207 |
29.6.2020 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
|
European Medicines Agency |
|
Domenico Scarlattilaan 6 |
|
1083 HS Amsterdam |
|
NETHERLANDS |
|
31.7.2020 |
EN |
Official Journal of the European Union |
C 253/9 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2020 to 30 June 2020
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2020/C 253/02)
— Issuing, maintenance or modification of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
INN (International Non-Proprietary Name) |
Holder(s) of the marketing authorisation |
Member State concerned |
Date of notification |
|
9.6.2020 |
fosfomycin-containing medicinal products |
fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol |
See Annex I |
See Annex I |
10.6.2020 |
|
25.6.2020 |
Carbamazepin Tillomed 200 and 400 mg prolonged-release tablets and associated names |
carbamazepine |
See Annex II |
See Annex II |
26.6.2020 |
|
9.6.2020 |
methocarbamol/paracetamol 380 mg/300 mg |
methocarbamol/paracetamol 380 mg/300 mg |
See Annex III |
See Annex III |
10.6.2020 |
— Suspension of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
INN (International Non-Proprietary Name) |
Holder(s) of the marketing authorisation |
Member State concerned |
Date of notification |
|
9.6.2020 |
fosfomycin-containing medicinal products |
fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol |
See Annex I |
See Annex I |
10.6.2020 |
ANNEX I
List of nationally authorised medicinal products
A. List of nationally authorised medicinal products recommended for variation
|
Member State in EEA |
Marketing authorisation holder |
Product name |
INN/Active substance + Strength |
Pharmaceutical form |
Route of Administration |
|
Austria |
Sandoz Gmbh |
Fosfomycin Sandoz |
Fosfomycin Disodium 10.56 g Vial |
Powder For Solution For Infusion |
Intravenous Use |
|
Austria |
Sandoz Gmbh |
Fosfomycin Sandoz |
Fosfomycin Disodium 5.28 g Vial |
Powder For Solution For Infusion |
Intravenous Use |
|
Austria |
Sandoz Gmbh |
Fosfomycin Sandoz |
Fosfomycin Disodium 1.32 g Vial |
Powder For Solution For Injection |
Intravenous Use |
|
Croatia |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fomicyt |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
Denmark |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fosfomycin Infectopharm |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
Finland |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fosfomycin Infectopharm |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
France |
Panpharma |
Fosfomycine Panpharma |
Fosfomycin 1 g Bottle |
Powder For Solution For Injection |
Intravenous Use |
|
France |
Panpharma |
Fosfomycine Panpharma |
Fosfomycin 1 g Vial |
Powder For Solution For Injection |
Intravenous Use |
|
France |
Panpharma |
Fosfomycine Panpharma |
Fosfomycin 4 g Bottle |
Powder For Solution For Injection |
Intravenous Use |
|
France |
Sanofi-Aventis France |
Fosfocine Iv |
Fosfomycin Sodium 1 g Vial |
Powder And Solvent For Solution For Injection |
Intravenous Use |
|
France |
Sanofi-Aventis France |
Fosfocine Iv |
Fosfomycin Sodium 4 g Vial |
Powder And Solvent For Solution For Injection |
Intravenous Use |
|
Germany |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fosfomycin Infectopharm |
Fosfomycin Sodium 10.56 g/10.76 g |
Powder For Solution For Infusion |
Intravenous Use |
|
Germany |
Infectopharm Arzneimittel Und Consilium Gmbh |
Infectofos |
Fosfomycin Sodium 10.56 g/10.76 g |
Powder For Solution For Infusion |
Intravenous Use |
|
Germany |
Infectopharm Arzneimittel Und Consilium Gmbh |
Infectofos |
Fosfomycin Sodium 2.64 g/2.69 g |
Powder For Solution For Infusion |
Intravenous Use |
|
Germany |
Infectopharm Arzneimittel Und Consilium Gmbh |
Infectofos |
Fosfomycin Sodium 3.96 g/4.04 g |
Powder For Solution For Infusion |
Intravenous Use |
|
Germany |
Infectopharm Arzneimittel Und Consilium Gmbh |
Infectofos |
Fosfomycin Sodium 6.6 g/6.73 g |
Powder For Solution For Infusion |
Intravenous Use |
|
Greece |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fomicyt |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
Ireland |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fomicyt |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
Italy |
Infectopharm Arzneimittel Und Consilium Gmbh |
Infectofos |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
Netherlands |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fomicyt |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
Norway |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fosfomycin Infectopharm |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
Poland |
Infectopharm Arzneimittel Und Consilium Gmbh |
Infectofos |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
Spain |
Laboratorios Ern, S.A. |
Fosfocina Intravenosa |
Fosfomycin Disodium 1 g Vial |
Powder And Solvent For Solution For Injection |
Intravenous Use |
|
Spain |
Laboratorios Ern, S.A. |
Fosfocina Intravenosa |
Fosfomycin Disodium 4 g Vial |
Powder For Solution For Injection |
Intravenous Use |
|
Spain |
Laboratorios Ern, S.A. |
Fosfomicina Intravenosa Level |
Fosfomycin 4 g Vial |
Powder For Solution For Injection |
Intravenous Use |
|
Sweden |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fosfomycin Infectopharm |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
United Kingdom |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fomicyt |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
|
United Kingdom |
Infectopharm Arzneimittel Und Consilium Gmbh |
Fosfomycin Infectopharm Arzneimittel Und Consilium |
Fosfomycin 40 mg/Ml |
Powder For Solution For Infusion |
Intravenous Use |
B. List of nationally authorised medicinal products recommended for variation and subject to conditions on the marketing authorisation
|
Member State in EEA |
Marketing authorisation holder |
Product name |
INN/Active substance + Strength |
Pharmaceutical form |
Route of Administration |
|
Austria |
Zambon S.P.A. |
Monuril |
Fosfomycin Trometamol 5,631 g Bag |
Granules For Oral Solution |
Oral Use |
|
Austria |
Dr Friedrich Eberth Arzneimittel Gmbh |
Fosfomycin Eberth |
Fosfomycin Trometamol 5,631 g/8 g |
Granules For Oral Solution |
Oral Use |
|
Austria |
Aristo Pharma Gmbh (Art 57) |
Cystium |
Fosfomycin Trometamol 5631 mg Sachet |
Powder For Oral Solution |
Oral Use |
|
Belgium |
Zambon Nv |
Monuril |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Bulgaria |
Zentiva, K.S. |
Фосфомицин Зентива |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Bulgaria |
Adipharm Ead |
Фосфосептик |
Fosfomycin Trometamol 5631 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Bulgaria |
Zambon S.P.A. |
Монурал |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Bulgaria |
Zentiva, K.S. |
Фосфомицин Зентива |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Croatia |
Pharmas D.O.O. |
Urifos |
Fosfomycin 3 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Croatia |
Jadran-Galenski Laboratorij D.D. |
Fosfomicin Jgl |
Fosfomycin Trometamol 3 g Bag |
Granules For Oral Solution |
Oral Use |
|
Croatia |
Sandoz D.O.O. |
Urinex |
Fosfomycin Trometamol 3 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Czech Republic |
Exeltis Czech S.R.O. |
Urifos |
Fosfomycin Trometamol 5631 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Czech Republic |
Apogepha Arzneimittel Gmbh |
Rapidnorm |
Fosfomycin Trometamol 5631 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Denmark |
Zambon S.P.A. |
Monurol |
Fosfomycin 2 g Units |
Granules For Oral Solution |
Oral Use |
|
Denmark |
Zambon S.P.A. |
Monurol |
Fosfomycin 3 g Units |
Granules For Oral Solution |
Oral Use |
|
Estonia |
Zentiva, K.S. |
Fosfomycin Zentiva |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Estonia |
Zentiva, K.S. |
Fosfomycin Zentiva |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Mylan S.A.S |
Fosfomycine Adultes Mylan Pharma |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Ranbaxy Pharmacie Generiques |
Fosfomycine Ranbaxy |
Fosfomycin Trometamol 5631 mg |
Granules For Oral Solution In Sachet |
Oral Use |
|
France |
Cristers |
Fosfomycine Adultes Cristers |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Therabel Lucien Pharma S.A. |
Uridoz |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
France |
Laboratoires Urgo Healthcare |
Fosfomycine Adultes Urgo |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Eg Labo Laboratoires Eurogenerics |
Fosfomycine Eg |
Fosfomycin 3 g/8 g |
Granules For Oral Solution |
Oral Use |
|
France |
Laboratoires Gerda |
Fosfomycine Adultes Gerda |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Arrow Generiques |
Fosfomycine Adultes Arrow |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Zentiva France |
Fosfomycine Adultes Zentiva |
Fosfomycin Trometamol 3 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Nexmed Pharma |
Fosfopharm |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
France |
Evolupharm |
Fosfomycine Adultes Evolugen |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Zambon France S.A. |
Fostrofemge |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
France |
Zambon France S.A. |
Gynofostrome |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
France |
Zambon France S.A. |
Monuril |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
France |
Biogaran |
Fosfomycine Biogaran |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Sanofi-Aventis France |
Fosfomycine Adultes Zentiva |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Teva Santé |
Fosfomycine Adultes Teva Sante |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
France |
Sandoz |
Fosfomycine Sandoz |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
France |
Laboratoires Neitum |
Urofast Adultes |
Fosfomycin Trometamol 5,631 g Units |
Oral Solution |
Oral |
|
Germany |
Aliud Pharma Gmbh |
Fosfomycin Al |
Fosfomycin Trometamol 5,631 g Dose |
Granules For Oral Solution |
Oral Use |
|
Germany |
Zambon Gmbh |
Monuril |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Germany |
Uropharm Ag |
Fosfomycin Uropharm |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Germany |
Dr Friedrich Eberth Arzneimittel Gmbh |
Fosfomycin Eberth |
Fosfomycin Trometamol 5,631 g/8 g |
Granules For Oral Solution |
Oral Use |
|
Germany |
Aristo Pharma Gmbh (Art 57) |
Fosfomycin Aristo |
Fosfomycin Trometamol 5631 mg Bag |
Powder For Oral Solution |
Oral Use |
|
Germany |
Apogepha Arzneimittel Gmbh |
Fosfuro |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Greece |
Vocate Φαρμακευτικη Αε |
Fosfocin |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Hungary |
Exeltis Magyarország Kft. |
Fosfomycin Exeltis |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Hungary |
Zambon S.P.A. |
Monural |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Ireland |
Zambon S.P.A. |
Monuril |
Fosfomycin Trometamol 3 g Units |
Granules For Oral Solution |
Oral Use |
|
Italy |
Mylan S.P.A. |
Fosfomicina Adulti Mylan |
Fosfomycin 3 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Ranbaxy Italia S.P.A. |
Fosfomicina Adulti Ranbaxy |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Ranbaxy Italia S.P.A. |
Fosfomicina Adulti Ranbaxy |
Fosfomycin Trometamol 5,631 g/Ml |
Granules For Oral Solution |
Oral Use |
|
Italy |
Ranbaxy Italia S.P.A. |
Fosfomicina Bambini Ranbaxy |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Dymalife Pharmaceutical S.R.L. |
Interfos Adulti |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Eg S.P.A. |
Fosfomicina Eg |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Aurobindo Pharma (Italia) S.R.L. |
Fosfomicina Adulti Aurobindo |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Zentiva Italia Srl |
Fosfomicina Zentiva |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Zentiva Italia Srl |
Fosfomicina Zentiva |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
S.F. Group Srl |
Infeur Adulti |
Fosfomycin 3 g Bag |
Granules For Oral Solution |
Oral Use |
|
Italy |
Doc Generici S.R.L. |
Fosfomicina Adulti Doc |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Zambon Italia S.R.L. |
Monuril |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Zambon Italia S.R.L. |
Monuril Bambini |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Zambon Italia S.R.L. |
Monuril Bambini |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Pensa Pharma S.P.A. |
Fosfomicina Pensa |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
So.Se.Pharm S.R.L. |
Berny |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Aristo Pharma Gmbh (Art 57) |
Fosfomicina Adulti Aristo |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Aristo Pharma Gmbh (Art 57) |
Fosfomicina Bambini Aristo |
Fosfomycin Trometamol 3,754 g |
Granules For Oral Solution |
Oral Use |
|
Italy |
Zentiva Italia Srl |
Fosfomicina Zentiva |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Zentiva Italia Srl |
Fosfomicina Zentiva |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Ratiopharm Gmbh |
Fosfomicina Adulti Ratiopharm |
Fosfomycin 3 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Sandoz S.P.A. |
Fosfomicina Adulti Sandoz |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
Sandoz S.P.A. |
Fosfomicina Bambini Sandoz |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Italy |
C&g Farmaceutici |
Danifos Adulti |
Fosfomycin Trometamol 5,631 g Packet |
Granules For Oral Solution |
Oral Use |
|
Lithuania |
Zentiva, K.S. |
Fosfomycin Zentiva |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Lithuania |
Zentiva, K.S. |
Fosfomycin Zentiva |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Luxembourg |
Zambon Nv |
Monuril |
Fosfomycin Trometamol 5,631 g |
Granules For Oral Solution |
Oral Use |
|
Malta |
Zambon S.P.A. |
Monuril |
Fosfomycin Trometamol 3 g Units |
Granules For Oral Solution |
Oral Use |
|
Netherlands |
Zambon Nederland B.V. |
Monuril |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Poland |
Exeltis Poland Sp. Z O.O. |
Afastural |
Fosfomycin Trometamol 3 g Sachet |
Granules For Oral Solution In Sachet |
Oral |
|
Poland |
Exeltis Poland Sp. Z O.O. |
Afastural |
Fosfomycin Trometamol 5631 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Poland |
Symphar Sp. Z O.O. |
Symural |
Fosfomycin 3 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Poland |
Zambon S.P.A. |
Monural |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Poland |
Labiana Pharmaceuticals, S.L.U. |
Uromaste |
Fosfomycin 3 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Portugal |
Pharma Bavaria Internacional Portugal Unip. Lda |
Fosmol |
Fosfomycin Trometamol 5631 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Portugal |
Pharmakern Portugal — Produtos Farmacêuticos, Sociedade Unipessoal, Lda. |
Fosfomicina Pharmakern |
Fosfomycin 3 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Portugal |
Generis Farmacêutica, S.A. |
Fosfomicina Generis |
Fosfomycin 3000 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Portugal |
Zambon — Produtos Farmacêuticos, Lda. |
Monuril |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Portugal |
Zambon — Produtos Farmacêuticos, Lda. |
Monuril |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Portugal |
Tolife — Produtos Farmacêuticos, S.A. |
Fosfomicina Tolife |
Fosfomycin Trometamol 3000 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Romania |
Labiana Pharmaceuticals S.L.U. |
Fosfomicina Labiana |
Fosfomycin 3 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Romania |
Zambon S.P.A. |
Monural |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Slovakia |
Exeltis Slovakia |
Afastural |
Fosfomycin Trometamol 3 g Sachet |
Granules For Oral Suspension In Sachet |
Oral |
|
Slovakia |
Zambon S.P.A. |
Monural |
Fosfomycin 3 g Units |
Granules For Oral Solution |
Oral Use |
|
Slovakia |
Dr Friedrich Eberth Arzneimittel Gmbh |
Fosfomycín Eberth |
Fosfomycin Trometamol 5,631 g/8 g |
Granules For Oral Solution |
Oral Use |
|
Spain |
Kern Pharma, S.L. |
Fosfomicina Kern Pharma |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Spain |
Labiana Pharmaceuticals S.L.U. |
Fosfomicina Labiana Pharma |
Fosfomycin 3 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Spain |
Labiana Pharmaceuticals S.L.U. |
Fosfomicina Labiana |
Fosfomycin 3 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Spain |
Laboratorios Q Pharma S.L. |
Solufos |
Fosfomycin Calcium 703 mg Capsule |
Capsule, Hard |
Oral Use |
|
Spain |
Laboratorio Stada, S.L. |
Fosfomicina Stada |
Fosfomycin 3 g/8 g |
Granules For Oral Solution |
Oral Use |
|
Spain |
Farmalider, S.A. |
Fosfomicina Farmalider |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Spain |
Arafarma Group, S.A |
Uroseptic |
Fosfomycin Trometamol 5,631 g Sachet |
Powder For Oral Solution In Sachet |
Oral Use |
|
Spain |
Zambon, S.A.U. |
Monurol |
Fosfomycin 3 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Spain |
Qualigen, S.L. |
Fosfomicina Qualigen |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Spain |
Laboratorios Ern, S.A. |
Fosfocina |
Fosfomycin Calcium 500 mg Capsule |
Capsule, Hard |
Oral Use |
|
Spain |
Laboratorios Ern, S.A. |
Fosfocina |
Fosfomycin Calcium 250 mg/5ml |
Powder For Oral Suspension |
Oral Use |
|
Spain |
Abamed Pharma, S.L. |
Fosfomicina Abamed Pharma |
Fosfomycin 3 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Spain |
Abamed Pharma, S.L. |
Fosfomicina Abamed |
Fosfomycin 3 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Spain |
Pensa Pharma, S.A.U. |
Fosfomicina Pensa |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Spain |
Tarbis Farma, S.L. |
Fosfomicina Tarbis |
Fosfomycin Trometamol 3 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Sweden |
Zambon S.p.A |
Monurelle |
Fosfomycin 3 g Dose |
Granules For Oral Solution |
Oral Use |
|
United Kingdom |
Exeltis Poland Sp. Z O.O. |
Fosfomycin Temapharm Sp. Z O.O. |
Fosfomycin Trometamol 5631 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
United Kingdom |
Mercury Pharmaceuticals Ltd. |
Fosfomycin Mercury Pharmaceuticals |
Fosfomycin Trometamol 5631 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
United Kingdom |
Zambon S.P.A. |
Monuril |
Fosfomycin Trometamol 5,631 g Sachet |
Granules For Oral Solution |
Oral Use |
C. List of nationally authorised medicinal products recommended for suspension
|
Member State in EEA |
Marketing authorisation holder |
Product name |
INN/Active substance + Strength |
Pharmaceutical form |
Route of Administration |
|
Croatia |
Pharmas D.O.O. |
Urifos |
Fosfomycin 2 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Estonia |
Zentiva, K.S. |
Fosfomycin Zentiva |
Fosfomycin 2 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Lithuania |
Zentiva, K.S. |
Fosfomycin Zentiva |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Lithuania |
Zentiva, K.S. |
Fosfomycin Zentiva |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Netherlands |
Zambon Nederland B.V. |
Monuril |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Poland |
Labiana Pharmaceuticals, S.L.U. |
Uromaste |
Fosfomycin 2 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Poland |
Zambon S.P.A. |
Monural |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Portugal |
Pharmakern Portugal — Produtos Farmacêuticos, Sociedade Unipessoal, Lda. |
Fosfomicina Pharmakern |
Fosfomycin 2 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Portugal |
Generis Farmacêutica, S.A. |
Fosfomicina Generis |
Fosfomycin 2000 mg Sachet |
Granules For Oral Solution |
Oral Use |
|
Portugal |
Zambon — Produtos Farmacêuticos, Lda. |
Monuril |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Romania |
Labiana Pharmaceuticals S.L.U. |
Fosfomicina Labiana |
Fosfomycin 2 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Romania |
Zambon S.P.A. |
Monural Pediatric |
Fosfomycin Trometamol 3,754 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Spain |
Labiana Pharmaceuticals S.L.U. |
Fosfomicina Labiana Pharma |
Fosfomycin 2 g Sachet |
Granules For Oral Solution |
Oral Use |
|
Spain |
Labiana Pharmaceuticals S.L.U. |
Fosfomicina Labiana |
Fosfomycin 2 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Spain |
Arafarma Group, S.A |
Uroseptic |
Fosfomycin Trometamol 3,754 g Sachet |
Powder For Oral Solution In Sachet |
Oral Use |
|
Spain |
Zambon, S.A.U. |
Monurol |
Fosfomycin 2 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Spain |
Abamed Pharma, S.L. |
Fosfomicina Abamed |
Fosfomycin 2 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Spain |
Abamed Pharma, S.L. |
Fosfomicina Abamed Pharma |
Fosfomycin 2 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Spain |
Tarbis Farma, S.L. |
Fosfomicina Tarbis |
Fosfomycin Trometamol 2 g Sachet |
Granules For Oral Solution In Sachet |
Oral Use |
|
Spain |
Laboratorios Ern, S.A. |
Fosfocina Intramuscuar |
Fosfomycin Disodium 1 g Vial, Lidocaine Hydrochloride 30 mg Vial |
Powder And Solvent For Solution For Injection |
Intramuscular Use |
|
Spain |
Laboratorios Ern, S.A. |
Fosfomicina Intramuscular Level |
Fosfomycin 1 g Vial |
Powder And Solvent For Solution For Injection |
Intramuscular Use |
ANNEX II
List of medicinal products and presentations
|
Member State EU/EEA |
Applicant company name, address |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
|
Croatia |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Karbamazepin Tillomed 200 mg tablete s produljenim oslobađanjem |
200 mg |
Prolonged-release tablet |
Oral use |
|
Croatia |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Karbamazepin Tillomed 400 mg tablete s produljenim oslobađanjem |
400 mg |
Prolonged-release tablet |
Oral use |
|
Germany |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepin Tillomed 200 mg Retardtabletten |
200 mg |
Prolonged-release tablet |
Oral use |
|
Germany |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepin Tillomed 400 mg Retardtabletten |
400 mg |
Prolonged-release tablet |
Oral use |
|
Italy |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepina Tillomed |
200 mg |
Prolonged-release tablet |
Oral use |
|
Italy |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepina Tillomed |
400 mg |
Prolonged-release tablet |
Oral use |
|
The Netherlands |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepine Tillomed 200 mg tabletten met verlengde afgifte |
200 mg |
Prolonged-release tablet |
Oral use |
|
The Netherlands |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepine Tillomed 400 mg tabletten met verlengde afgifte |
400 mg |
Prolonged-release tablet |
Oral use |
|
Poland |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Karbamazepina Tillomed |
200 mg |
Prolonged-release tablet |
Oral use |
|
Poland |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Karbamazepina Tillomed |
400 mg |
Prolonged-release tablet |
Oral use |
|
Sweden |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepine Tillomed |
200 mg |
Prolonged-release tablet |
Oral use |
|
Sweden |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepine Tillomed |
400 mg |
Prolonged-release tablet |
Oral use |
|
United Kingdom |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepine Tillomed 200 mg Prolonged-Release Tablets |
200 mg |
Prolonged-release tablet |
Oral use |
|
United Kingdom |
Laboratorios Tillomed Spain S.L.U. Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain |
Carbamazepine Tillomed 400 mg Prolonged-Release Tablets |
400 mg |
Prolonged-release tablet |
Oral use |
ANNEX III
List of nationally authorised medicinal products
|
Member State EU/EEA |
Applicant |
Marketing authorisation holder |
Invented name |
INN + Strength |
Pharmaceutical form |
Route of administration |
|
Germany |
DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH |
|
Methocarbamol/Paracetamol 380 mg/300 mg |
Methocarbamol 380 mg, Paracetamol 300 mg |
tablet |
oral use |
|
Spain |
|
Faes Farma, S.A. |
Robaxisal Compuesto |
Methocarbamol 380 mg, Paracetamol 300 mg |
tablet |
oral use |
|
United Kingdom |
DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH |
|
Methocarbamol/Paracetamol 380 mg/300 mg |
Methocarbamol 380 mg, Paracetamol 300 mg |
tablet |
oral use |