# Official Journal C 253/31 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 253 |
| | |
| English edition | Information and Notices | Volume 6331 July 2020 |

ISSN 1977-091X

Official Journal

of the European Union

C 253

English edition

Information and Notices

Volume 6331 July 2020

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2020/C 253/01 | 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 253/02 | 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 or Article 38 of Directive 2001/82/EC) | 9 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2020/C 253/01

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)

(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 253/02

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 or Article 38 of Directive 2001/82/EC)

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

9

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 31.7.2020 | EN | Official Journal of the European Union | C 253/1 |
| --- | --- | --- | --- |

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 |

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 |
| 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 |

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

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 |

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 |

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 |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 31.7.2020 | EN | Official Journal of the European Union | C 253/9 |
| --- | --- | --- | --- |

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 |

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 |

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

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

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 |

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 |

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 |

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 |

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

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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 |

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

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