# C_2020253EN.01000901.xml

| 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

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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

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

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

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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

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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

---