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)
Date: 2020-07-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2020253EN.01000901.xml










31.7.2020   


EN


Official Journal of the European Union


C 253/9






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2020 to 30 June 2020
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2020/C 253/02)
—   Issuing, maintenance or modification of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




9.6.2020


fosfomycin-containing medicinal products


fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol


See Annex I


See Annex I


10.6.2020




25.6.2020


Carbamazepin Tillomed 200 and 400 mg prolonged-release tablets and associated names


carbamazepine


See Annex II


See Annex II


26.6.2020




9.6.2020


methocarbamol/paracetamol 380 mg/300 mg


methocarbamol/paracetamol 380 mg/300 mg


See Annex III


See Annex III


10.6.2020




—   Suspension of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




9.6.2020


fosfomycin-containing medicinal products


fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol


See Annex I


See Annex I


10.6.2020






(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




B.   List of nationally authorised medicinal products recommended for variation and subject to conditions on the marketing authorisation











Member State in EEA


Marketing authorisation holder


Product name


INN/Active substance + Strength


Pharmaceutical form


Route of Administration




Austria


Zambon S.P.A.


Monuril


Fosfomycin Trometamol 5,631  g Bag


Granules For Oral Solution


Oral Use




Austria


Dr Friedrich Eberth Arzneimittel Gmbh


Fosfomycin Eberth


Fosfomycin Trometamol 5,631  g/8 g


Granules For Oral Solution


Oral Use




Austria


Aristo Pharma Gmbh (Art 57)


Cystium


Fosfomycin Trometamol 5631 mg Sachet


Powder For Oral Solution


Oral Use




Belgium


Zambon Nv


Monuril


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Bulgaria


Zentiva, K.S.


Фосфомицин Зентива


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Bulgaria


Adipharm Ead


Фосфосептик


Fosfomycin Trometamol 5631 mg Sachet


Granules For Oral Solution


Oral Use




Bulgaria


Zambon S.P.A.


Монурал


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Bulgaria


Zentiva, K.S.


Фосфомицин Зентива


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Croatia


Pharmas D.O.O.


Urifos


Fosfomycin 3 g Sachet


Granules For Oral Solution


Oral Use




Croatia


Jadran-Galenski Laboratorij D.D.


Fosfomicin Jgl


Fosfomycin Trometamol 3 g Bag


Granules For Oral Solution


Oral Use




Croatia


Sandoz D.O.O.


Urinex


Fosfomycin Trometamol 3 mg Sachet


Granules For Oral Solution


Oral Use




Czech Republic


Exeltis Czech S.R.O.


Urifos


Fosfomycin Trometamol 5631 mg Sachet


Granules For Oral Solution


Oral Use




Czech Republic


Apogepha Arzneimittel Gmbh


Rapidnorm


Fosfomycin Trometamol 5631 mg Sachet


Granules For Oral Solution


Oral Use




Denmark


Zambon S.P.A.


Monurol


Fosfomycin 2 g Units


Granules For Oral Solution


Oral Use




Denmark


Zambon S.P.A.


Monurol


Fosfomycin 3 g Units


Granules For Oral Solution


Oral Use




Estonia


Zentiva, K.S.


Fosfomycin Zentiva


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Estonia


Zentiva, K.S.


Fosfomycin Zentiva


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Mylan S.A.S


Fosfomycine Adultes Mylan Pharma


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Ranbaxy Pharmacie Generiques


Fosfomycine Ranbaxy


Fosfomycin Trometamol 5631 mg


Granules For Oral Solution In Sachet


Oral Use




France


Cristers


Fosfomycine Adultes Cristers


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Therabel Lucien Pharma S.A.


Uridoz


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution In Sachet


Oral Use




France


Laboratoires Urgo Healthcare


Fosfomycine Adultes Urgo


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Eg Labo Laboratoires Eurogenerics


Fosfomycine Eg


Fosfomycin 3 g/8 g


Granules For Oral Solution


Oral Use




France


Laboratoires Gerda


Fosfomycine Adultes Gerda


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Arrow Generiques


Fosfomycine Adultes Arrow


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Zentiva France


Fosfomycine Adultes Zentiva


Fosfomycin Trometamol 3 g Sachet


Granules For Oral Solution


Oral Use




France


Nexmed Pharma


Fosfopharm


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution In Sachet


Oral Use




France


Evolupharm


Fosfomycine Adultes Evolugen


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Zambon France S.A.


Fostrofemge


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution In Sachet


Oral Use




France


Zambon France S.A.


Gynofostrome


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution In Sachet


Oral Use




France


Zambon France S.A.


Monuril


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution In Sachet


Oral Use




France


Biogaran


Fosfomycine Biogaran


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Sanofi-Aventis France


Fosfomycine Adultes Zentiva


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Teva Santé


Fosfomycine Adultes Teva Sante


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




France


Sandoz


Fosfomycine Sandoz


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution In Sachet


Oral Use




France


Laboratoires Neitum


Urofast Adultes


Fosfomycin Trometamol 5,631  g Units


Oral Solution


Oral




Germany


Aliud Pharma Gmbh


Fosfomycin Al


Fosfomycin Trometamol 5,631  g Dose


Granules For Oral Solution


Oral Use




Germany


Zambon Gmbh


Monuril


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Germany


Uropharm Ag


Fosfomycin Uropharm


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Germany


Dr Friedrich Eberth Arzneimittel Gmbh


Fosfomycin Eberth


Fosfomycin Trometamol 5,631  g/8 g


Granules For Oral Solution


Oral Use




Germany


Aristo Pharma Gmbh (Art 57)


Fosfomycin Aristo


Fosfomycin Trometamol 5631 mg Bag


Powder For Oral Solution


Oral Use




Germany


Apogepha Arzneimittel Gmbh


Fosfuro


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Greece


Vocate Φαρμακευτικη Αε


Fosfocin


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Hungary


Exeltis Magyarország Kft.


Fosfomycin Exeltis


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Hungary


Zambon S.P.A.


Monural


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Ireland


Zambon S.P.A.


Monuril


Fosfomycin Trometamol 3 g Units


Granules For Oral Solution


Oral Use




Italy


Mylan S.P.A.


Fosfomicina Adulti Mylan


Fosfomycin 3 g Sachet


Granules For Oral Solution


Oral Use




Italy


Ranbaxy Italia S.P.A.


Fosfomicina Adulti Ranbaxy


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Ranbaxy Italia S.P.A.


Fosfomicina Adulti Ranbaxy


Fosfomycin Trometamol 5,631  g/Ml


Granules For Oral Solution


Oral Use




Italy


Ranbaxy Italia S.P.A.


Fosfomicina Bambini Ranbaxy


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Italy


Dymalife Pharmaceutical S.R.L.


Interfos Adulti


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Eg S.P.A.


Fosfomicina Eg


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Aurobindo Pharma (Italia) S.R.L.


Fosfomicina Adulti Aurobindo


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Zentiva Italia Srl


Fosfomicina Zentiva


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Italy


Zentiva Italia Srl


Fosfomicina Zentiva


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


S.F. Group Srl


Infeur Adulti


Fosfomycin 3 g Bag


Granules For Oral Solution


Oral Use




Italy


Doc Generici S.R.L.


Fosfomicina Adulti Doc


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Zambon Italia S.R.L.


Monuril


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Zambon Italia S.R.L.


Monuril Bambini


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Italy


Zambon Italia S.R.L.


Monuril Bambini


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Italy


Pensa Pharma S.P.A.


Fosfomicina Pensa


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


So.Se.Pharm S.R.L.


Berny


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Aristo Pharma Gmbh (Art 57)


Fosfomicina Adulti Aristo


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Aristo Pharma Gmbh (Art 57)


Fosfomicina Bambini Aristo


Fosfomycin Trometamol 3,754  g


Granules For Oral Solution


Oral Use




Italy


Zentiva Italia Srl


Fosfomicina Zentiva


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Italy


Zentiva Italia Srl


Fosfomicina Zentiva


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Ratiopharm Gmbh


Fosfomicina Adulti Ratiopharm


Fosfomycin 3 g Sachet


Granules For Oral Solution


Oral Use




Italy


Sandoz S.P.A.


Fosfomicina Adulti Sandoz


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Italy


Sandoz S.P.A.


Fosfomicina Bambini Sandoz


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Italy


C&g Farmaceutici


Danifos Adulti


Fosfomycin Trometamol 5,631  g Packet


Granules For Oral Solution


Oral Use




Lithuania


Zentiva, K.S.


Fosfomycin Zentiva


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Lithuania


Zentiva, K.S.


Fosfomycin Zentiva


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Luxembourg


Zambon Nv


Monuril


Fosfomycin Trometamol 5,631  g


Granules For Oral Solution


Oral Use




Malta


Zambon S.P.A.


Monuril


Fosfomycin Trometamol 3 g Units


Granules For Oral Solution


Oral Use




Netherlands


Zambon Nederland B.V.


Monuril


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Poland


Exeltis Poland Sp. Z O.O.


Afastural


Fosfomycin Trometamol 3 g Sachet


Granules For Oral Solution In Sachet


Oral




Poland


Exeltis Poland Sp. Z O.O.


Afastural


Fosfomycin Trometamol 5631 mg Sachet


Granules For Oral Solution


Oral Use




Poland


Symphar Sp. Z O.O.


Symural


Fosfomycin 3 g Sachet


Granules For Oral Solution


Oral Use




Poland


Zambon S.P.A.


Monural


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Poland


Labiana Pharmaceuticals, S.L.U.


Uromaste


Fosfomycin 3 g Sachet


Granules For Oral Solution


Oral Use




Portugal


Pharma Bavaria Internacional Portugal Unip. Lda


Fosmol


Fosfomycin Trometamol 5631 mg Sachet


Granules For Oral Solution


Oral Use




Portugal


Pharmakern Portugal — Produtos Farmacêuticos, Sociedade Unipessoal, Lda.


Fosfomicina Pharmakern


Fosfomycin 3 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Portugal


Generis Farmacêutica, S.A.


Fosfomicina Generis


Fosfomycin 3000 mg Sachet


Granules For Oral Solution


Oral Use




Portugal


Zambon — Produtos Farmacêuticos, Lda.


Monuril


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Portugal


Zambon — Produtos Farmacêuticos, Lda.


Monuril


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Portugal


Tolife — Produtos Farmacêuticos, S.A.


Fosfomicina Tolife


Fosfomycin Trometamol 3000 mg Sachet


Granules For Oral Solution


Oral Use




Romania


Labiana Pharmaceuticals S.L.U.


Fosfomicina Labiana


Fosfomycin 3 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Romania


Zambon S.P.A.


Monural


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Slovakia


Exeltis Slovakia


Afastural


Fosfomycin Trometamol 3 g Sachet


Granules For Oral Suspension In Sachet


Oral




Slovakia


Zambon S.P.A.


Monural


Fosfomycin 3 g Units


Granules For Oral Solution


Oral Use




Slovakia


Dr Friedrich Eberth Arzneimittel Gmbh


Fosfomycín Eberth


Fosfomycin Trometamol 5,631  g/8 g


Granules For Oral Solution


Oral Use




Spain


Kern Pharma, S.L.


Fosfomicina Kern Pharma


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Spain


Labiana Pharmaceuticals S.L.U.


Fosfomicina Labiana Pharma


Fosfomycin 3 g Sachet


Granules For Oral Solution


Oral Use




Spain


Labiana Pharmaceuticals S.L.U.


Fosfomicina Labiana


Fosfomycin 3 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Spain


Laboratorios Q Pharma S.L.


Solufos


Fosfomycin Calcium 703 mg Capsule


Capsule, Hard


Oral Use




Spain


Laboratorio Stada, S.L.


Fosfomicina Stada


Fosfomycin 3 g/8 g


Granules For Oral Solution


Oral Use




Spain


Farmalider, S.A.


Fosfomicina Farmalider


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Spain


Arafarma Group, S.A


Uroseptic


Fosfomycin Trometamol 5,631  g Sachet


Powder For Oral Solution In Sachet


Oral Use




Spain


Zambon, S.A.U.


Monurol


Fosfomycin 3 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Spain


Qualigen, S.L.


Fosfomicina Qualigen


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Spain


Laboratorios Ern, S.A.


Fosfocina


Fosfomycin Calcium 500 mg Capsule


Capsule, Hard


Oral Use




Spain


Laboratorios Ern, S.A.


Fosfocina


Fosfomycin Calcium 250 mg/5ml


Powder For Oral Suspension


Oral Use




Spain


Abamed Pharma, S.L.


Fosfomicina Abamed Pharma


Fosfomycin 3 g Sachet


Granules For Oral Solution


Oral Use




Spain


Abamed Pharma, S.L.


Fosfomicina Abamed


Fosfomycin 3 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Spain


Pensa Pharma, S.A.U.


Fosfomicina Pensa


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




Spain


Tarbis Farma, S.L.


Fosfomicina Tarbis


Fosfomycin Trometamol 3 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Sweden


Zambon S.p.A


Monurelle


Fosfomycin 3 g Dose


Granules For Oral Solution


Oral Use




United Kingdom


Exeltis Poland Sp. Z O.O.


Fosfomycin Temapharm Sp. Z O.O.


Fosfomycin Trometamol 5631 mg Sachet


Granules For Oral Solution


Oral Use




United Kingdom


Mercury Pharmaceuticals Ltd.


Fosfomycin Mercury Pharmaceuticals


Fosfomycin Trometamol 5631 mg Sachet


Granules For Oral Solution


Oral Use




United Kingdom


Zambon S.P.A.


Monuril


Fosfomycin Trometamol 5,631  g Sachet


Granules For Oral Solution


Oral Use




C.   List of nationally authorised medicinal products recommended for suspension











Member State in EEA


Marketing authorisation holder


Product name


INN/Active substance + Strength


Pharmaceutical form


Route of Administration




Croatia


Pharmas D.O.O.


Urifos


Fosfomycin 2 g Sachet


Granules For Oral Solution


Oral Use




Estonia


Zentiva, K.S.


Fosfomycin Zentiva


Fosfomycin 2 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Lithuania


Zentiva, K.S.


Fosfomycin Zentiva


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Lithuania


Zentiva, K.S.


Fosfomycin Zentiva


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Netherlands


Zambon Nederland B.V.


Monuril


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Poland


Labiana Pharmaceuticals, S.L.U.


Uromaste


Fosfomycin 2 g Sachet


Granules For Oral Solution


Oral Use




Poland


Zambon S.P.A.


Monural


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Portugal


Pharmakern Portugal — Produtos Farmacêuticos, Sociedade Unipessoal, Lda.


Fosfomicina Pharmakern


Fosfomycin 2 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Portugal


Generis Farmacêutica, S.A.


Fosfomicina Generis


Fosfomycin 2000 mg Sachet


Granules For Oral Solution


Oral Use




Portugal


Zambon — Produtos Farmacêuticos, Lda.


Monuril


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Romania


Labiana Pharmaceuticals S.L.U.


Fosfomicina Labiana


Fosfomycin 2 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Romania


Zambon S.P.A.


Monural Pediatric


Fosfomycin Trometamol 3,754  g Sachet


Granules For Oral Solution


Oral Use




Spain


Labiana Pharmaceuticals S.L.U.


Fosfomicina Labiana Pharma


Fosfomycin 2 g Sachet


Granules For Oral Solution


Oral Use




Spain


Labiana Pharmaceuticals S.L.U.


Fosfomicina Labiana


Fosfomycin 2 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Spain


Arafarma Group, S.A


Uroseptic


Fosfomycin Trometamol 3,754  g Sachet


Powder For Oral Solution In Sachet


Oral Use




Spain


Zambon, S.A.U.


Monurol


Fosfomycin 2 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Spain


Abamed Pharma, S.L.


Fosfomicina Abamed


Fosfomycin 2 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Spain


Abamed Pharma, S.L.


Fosfomicina Abamed Pharma


Fosfomycin 2 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Spain


Tarbis Farma, S.L.


Fosfomicina Tarbis


Fosfomycin Trometamol 2 g Sachet


Granules For Oral Solution In Sachet


Oral Use




Spain


Laboratorios Ern, S.A.


Fosfocina Intramuscuar


Fosfomycin Disodium 1 g Vial, Lidocaine Hydrochloride 30 mg Vial


Powder And Solvent For Solution For Injection


Intramuscular Use




Spain


Laboratorios Ern, S.A.


Fosfomicina Intramuscular Level


Fosfomycin 1 g Vial


Powder And Solvent For Solution For Injection


Intramuscular Use









ANNEX II
List of medicinal products and presentations










Member State EU/EEA


Applicant
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Croatia


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Karbamazepin Tillomed 200 mg tablete s produljenim
oslobađanjem


200 mg


Prolonged-release tablet


Oral use




Croatia


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Karbamazepin Tillomed 400 mg tablete s produljenim
oslobađanjem


400 mg


Prolonged-release tablet


Oral use




Germany


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepin Tillomed 200 mg Retardtabletten


200 mg


Prolonged-release tablet


Oral use




Germany


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepin Tillomed 400 mg Retardtabletten


400 mg


Prolonged-release tablet


Oral use




Italy


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepina Tillomed


200 mg


Prolonged-release tablet


Oral use




Italy


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepina Tillomed


400 mg


Prolonged-release tablet


Oral use




The Netherlands


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepine Tillomed 200 mg tabletten met verlengde afgifte


200 mg


Prolonged-release tablet


Oral use




The Netherlands


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepine Tillomed 400 mg tabletten met verlengde afgifte


400 mg


Prolonged-release tablet


Oral use




Poland


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Karbamazepina Tillomed


200 mg


Prolonged-release tablet


Oral use




Poland


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Karbamazepina Tillomed


400 mg


Prolonged-release tablet


Oral use




Sweden


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepine Tillomed


200 mg


Prolonged-release tablet


Oral use




Sweden


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepine Tillomed


400 mg


Prolonged-release tablet


Oral use




United Kingdom


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepine Tillomed 200 mg Prolonged-Release Tablets


200 mg


Prolonged-release tablet


Oral use




United Kingdom


Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spínola 8, planta 1, Puerta F, 28016, Madrid, Spain


Carbamazepine Tillomed 400 mg Prolonged-Release Tablets


400 mg


Prolonged-release tablet


Oral use









ANNEX III
List of nationally authorised medicinal products











Member State
EU/EEA


Applicant


Marketing authorisation holder


Invented name


INN + Strength


Pharmaceutical form


Route of administration




Germany


DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH


 


Methocarbamol/Paracetamol 380 mg/300 mg


Methocarbamol 380 mg, Paracetamol 300 mg


tablet


oral use




Spain


 


Faes Farma, S.A.


Robaxisal Compuesto


Methocarbamol 380 mg, Paracetamol 300 mg


tablet


oral use




United Kingdom


DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH


 


Methocarbamol/Paracetamol 380 mg/300 mg


Methocarbamol 380 mg, Paracetamol 300 mg


tablet


oral use