INN Invented name Strength Pharmaceutical Form. 150 mg Retardkapseln. 75 mg Retardkapseln. 75mg Hartkapseln. 150mg Hartkapseln

Transcription

1 Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of, marketing authorisation holders in the Member States 1

2 Annex IA: Products for which the marketing authorisations are recommended for maintenance Member State Austria Austria Austria Austria Austria Basics GmbH Hemmelrather Weg Leverkusen Basics GmbH Hemmelrather Weg Leverkusen Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm G.L. Pharma GmbH Schlossplatz Lannach Austria Venlafaxine Venlafaxin Ranbaxy 150 mg Retardkapseln 150 mg Prolonged - Venlafaxine Venlafaxin Ranbaxy 75 mg Prolonged - 75 mg Retardkapseln Venlafaxine Venlafaxin Bluefish 75 mg Prolonged - hydrochloride 75mg Hartkapseln retardiert Venlafaxine Venlafaxin Bluefish 150mg Prolonged - hydrochloride 150mg Hartkapseln retardiert Nebivolol Nebilan 5mg Tabletten 5 mg Tablet Austria G.L. Pharma GmbH Schlossplatz Lannach Austria Nebivolol Nebivolol G.L. 5 mg - Tabletten 5 mg Tablet 2

3 Austria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria ratiopharm Arzneimittei- Vertriebs-GmbH Albert-Schweitzer-Gasse Wien Austria Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Ecopharm Group AD bul. Cherni vrah 14, bl.3 Sofia 1421 Bulgaria Nebivolol NEBIVOLOL- RATIOPHARM 5 MG Tabletten 5 mg Tablet Levetiracetam Lyvam 250 mg Film - coated Levetiracetam Lyvam 500 mg Film - coated Levetiracetam Lyvam 750 mg Film - coated Levetiracetam Lyvam 1000 mg Film - coated Nebivolol Nevolen 5 mg Tablet 3

4 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Ewopharma International s.r.o., Hlavna 13 Bratislava Slovakia Ewopharma International s.r.o., Hlavna 13 Bratislava Slovakia G.L. Pharma GmbH Schlossplatz Lannach Austria Neo Balkanika EOOD 35 Zemliane Str. Sofia 1618 Bulgaria Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Fexofenadine Ewofex 120 mg Film - coated Fexofenadine Ewofex 180 mg Film - coated Nebivolol Nebilan 5 mg Tablet Nebivolol Bivolet 5 mg Tablet Bosentan Bosentan Sandoz 62,5 mg Film - coated Bosentan Bosentan Sandoz 125 mg Film - coated 4

5 Croatia Alkaloid d.o.o. Ulica grada Vukovara 226 F Zagreb Croatia Levetiracetam Lyvam 250 mg filmom obložene e 250 mg Film - coated Croatia Alkaloid d.o.o. Ulica grada Vukovara 226 F Zagreb Croatia Levetiracetam Lyvam 500 mg filmom obložene e 500 mg Film - coated Croatia Alkaloid d.o.o. Ulica grada Vukovara 226 F Zagreb Croatia Levetiracetam Lyvam 750 mg filmom obložene e 750 mg Film - coated Croatia Alkaloid d.o.o. Ulica grada Vukovara 226 F Zagreb Croatia Levetiracetam Lyvam 1000 mg filmom obložene e 1000 mg Film - coated Cyprus Delorbis Pharmaceuticals Ltd 17 Athinon Street Ergates Industrial Area 2643 Ergates P.O. Box Lefkosia Cyprus Levocetirizine hydrochloride Zobral 5 mg Film - coated 5

6 Czech Republic Abdi Farma, Unipessoal Lda. Quinta da Fonte, Rua dos Malhoes Edificio D. Pedro I Paco de Arcos Bosentan monohydrate Bosentan Abdi 62,5 mg potahované y 62,5 mg Film - coated Czech Republic Abdi Farma, Unipessoal Lda. Quinta da Fonte, Rua dos Malhoes Edificio D. Pedro I Paco de Arcos Bosentan monohydrate Bosentan Abdi 125 mg potahované y 125 mg Film - coated Czech Republic Biofarm Sp. z o.o. ul. Wałbrzyska Poznaň Levocetirizine hydrochloride Levocetirizin Biofarm 5 mg potahované y 5 mg Film - coated Czech Republic Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxine Bluefish 75 mg 75 mg Prolonged - Czech Republic Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxine Bluefish 150 mg 150 mg Prolonged - 6

7 Czech Republic Ewopharma International s.r.o., Hlavna 13 Bratislava Slovakia Fexofenadine hydrochloride Ewofex 120 mg potahované y 120 mg Film - coated Czech Republic Ewopharma International s.r.o., Hlavna 13 Bratislava Slovakia Fexofenadine hydrochloride Ewofex 180 mg potahované y 180 mg Film - coated Czech Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Levetiracetam Letiramyl 250 mg potahované y 250 mg Film - coated Czech Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Levetiracetam Letiramyl 500 mg potahované y 500 mg Film - coated Czech Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Levetiracetam Letiramyl 750 mg potahované y 750 mg Film - coated Czech Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Levetiracetam Letiramyl 1000 mg potahované y 1000 mg Film - coated 7

8 Czech Republic Sandoz s.r.o. U Nákladového nádrazí Prague 3 Czech Republic Bosentan monohydrate Bosentan Sandoz 62,5 mg 62,5 mg Film - coated Czech Republic Sandoz s.r.o. U Nákladového nádrazí Prague 3 Czech Republic Bosentan monohydrate Bosentan Sandoz 125 mg 125 mg Film - coated Czech Republic Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Prague 5 Czech Republic Bosentan monohydrate Bosentan Teva 125 mg potahované y 125 mg Film - coated Denmark Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D Hamburg Levocetirizine Levocetira 5 mg Film - coated Denmark Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D Hamburg Levocetirizine Levcetin 5 mg Film - coated Denmark Biofarm Sp. z o.o. ul. Wałbrzyska Poznaň Levocetirizine Levrin 5 mg Film - coated 8

9 Denmark Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlafaxine Bluefish 75 mg Prolonged - release capsule Denmark Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlafaxine Bluefish 150 mg Prolonged - release capsule Denmark Cipla Chanelle Generics Limited Athenry Road, Loughrea, Co Galway Ireland Fexofenadine Alterfast 120 mg Film - coated Denmark Cipla Chanelle Generics Limited Athenry Road, Loughrea, Co Galway Ireland Fexofenadine Alterfast 180 mg Film - coated Denmark Cipla Chanelle Generics Limited Athenry Road, Loughrea, Co Galway Ireland Fexofenadine Clarifast 120 mg Film - coated Denmark Cipla Chanelle Generics Limited Athenry Road, Loughrea, Co Galway Ireland Fexofenadine Clarifast 180 mg Film - coated 9

10 Denmark Cipla Chanelle Generics Limited Athenry Road, Loughrea, Co Galway Ireland Fexofenadine Histafast 120 mg Film - coated Denmark Cipla Chanelle Generics Limited Athenry Road, Loughrea, Co Galway Ireland Fexofenadine Histafast 180 mg Film - coated Denmark Mylan AB PO Box SE Stockholm Fexofenadine Nefoxef 120 mg Film - coated Denmark Mylan AB PO Box SE Stockholm Fexofenadine Nefoxef 180 mg Film - coated Denmark Norton Healthcare Ltd T/A Ivax Pharmaceuticals UK Ridings Point, Whistler Drive Castleford West Yorkshire WF10 5HX Fexofenadine Fexofenadinhydrochlorid "Ivax" 120 mg Film - coated 10

11 Denmark Denmark Denmark Denmark Estonia Norton Healthcare Ltd T/A Ivax Pharmaceuticals UK Ridings Point, Whistler Drive Castleford West Yorkshire WF10 5HX Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark G.L. Pharma GmbH Schlossplatz Lannach Austria Fexofenadine Fexofenadinhydrochlorid "Ivax" 180 mg Film - coated Metoclopramide Metoclopramide Orifarm 10 mg Tablet hydrochloride Fexofenadine Altifex 120 mg Film - coated Fexofenadine Altifex 180 mg Film - coated Nebivolol NEBITEN 5MG 5 mg Tablet Estonia Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine VENLAFAXINE ORION 37,5 mg Prolonged - 11

12 Estonia Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine VENLAFAXINE ORION 75 mg Prolonged - Estonia Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine VENLAFAXINE ORION 150 mg Prolonged - Estonia Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Bosentan BOSENTAN SANDOZ 62,5 mg Film - coated Estonia Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Bosentan BOSENTAN SANDOZ 125 mg Film - coated Estonia UAB Norameda Meistru 8a Vilnius LT Lithuania Bosentan BOSENTAN NORAMEDA 62,5 MG 62,5 mg Film - coated Estonia UAB Norameda Meistru 8a Vilnius LT Lithuania Bosentan BOSENTAN NORAMEDA 125 MG 125 mg Film - coated 12

13 Estonia Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine VENLAGAMMA 75 MG 75 mg Prolonged - Estonia Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine VENLAGAMMA 150 MG 150 mg Prolonged - Finland Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlafaxine Bluefish 75 mg Prolonged - Finland Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlafaxine Bluefish 150 mg Prolonged - Finland Mylan AB PO Box SE Stockholm Fexofenadine Nefoxef 120 mg Film - coated Finland Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine hydrochloride VENLAFAXIN ORION 37,5 mg Prolonged - 13

14 Finland Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine hydrochloride VENLAFAXIN ORION 75 mg Prolonged - Finland Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine hydrochloride VENLAFAXIN ORION 150 mg Prolonged - Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D Hamburg Levocetirizine Levocetira 5 mg comprimé pelliculé 5 mg Film - coated BIOGARAN 15, boulevard Charles de Gaulle Colombes Cedex Fexofenadine FEXOFENADINE BIOGARAN 120 mg, comprimé pelliculé 120 mg Film - coated BIOGARAN 15, boulevard Charles de Gaulle Colombes Cedex Fexofenadine FEXOFENADINE BIOGARAN 180 mg, comprimé pelliculé 180 mg Film - coated Mylan SAS 117 allée des Parcs Saint-Priest Cedex Fexofenadine FEXOFENADINE MYLAN 120 Film-coated Tablet 120 mg Film - coated 14

15 Mylan SAS 117 allée des Parcs Saint-Priest Cedex Fexofenadine FEXOFENADINE MYLAN 180 Film-coated Tablet 180 mg Film - coated Mylan SAS 117 allée des Parcs Saint-Priest Cedex Levetiracetam LEVETIRACETAM MYLAN PHARMA 250mg, comprimé pelliculé 250 mg Tablet Mylan SAS 117 allée des Parcs Saint-Priest Cedex Levetiracetam LEVETIRACETAM MYLAN PHARMA 500mg, comprimé pelliculé 500 mg Tablet Mylan SAS 117 allée des Parcs Saint-Priest Cedex Levetiracetam LEVETIRACETAM MYLAN PHARMA 1000mg, comprimé pelliculé 1000 mg Tablet Plus Pharmacie SA 26 Boulevard Paul Vaillant- Couturier F Ivry-sur-Seine NEBIVOLOL NEBIVOLOL ISOMED 5 mg, comprimé quadrisécable 5 mg Tablet Ranbaxy Pharmacie Generiques Quai Dion Bouton Puteaux Venlafaxine Venlafaxine Ranbaxy LP 37,5mg, gélule à libération prolongée 37,5 mg Prolonged - release capsule 15

16 Ranbaxy Pharmacie Generiques Quai Dion Bouton Puteaux Venlafaxine Venlafaxine Ranbaxy LP 75mg, gélule à libération prolongée 75 mg Prolonged - release capsule Ranbaxy Pharmacie Generiques Quai Dion Bouton Puteaux Venlafaxine Venlafaxine Ranbaxy LP 150mg, gélule à libération prolongée 150 mg Prolonged - release capsule ratiopharm GmbH Graf-Arco-Strasse 3 D Ulm NEBIVOLOL NEBIVOLOL RATIOPHARM 5 mg, comprimé quadrisécable 5 mg Tablet Teva Sante Cœur Défense Esplanade du Général de Gaulle La Défense Cedex Fexofenadine FEXOFENADINE TEVA 120 Film-coated Tablet 120 mg Film - coated Teva Sante Cœur Défense Esplanade du Général de Gaulle La Défense Cedex Fexofenadine FEXOFENADINE TEVA 180 Film-coated Tablet 180 mg Film - coated 16

17 AAA-Pharma GmbH Liebknechstrasse Stuttgart Venlafaxine Venlafaxin AAA 75 mg Hartkapseln, retardiert 75 mg Prolonged - AAA-Pharma GmbH Liebknechstrasse Stuttgart Venlafaxine Venlafaxin AAA 150 mg Hartkapseln, retardiert 150 mg Prolonged - AAA-Pharma GmbH Liebknechstrasse Stuttgart Venlafaxine Venlafaxin AAA 37,5 mg Hartkapseln, retardiert 37,5 mg Prolonged - Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D Hamburg Levocetirizine Levocetira 5 mg Filmten 5 mg Film - coated Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxin Bluefish 75 mg Hartkapsel, retardiert 75 mg Prolonged - Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxin Bluefish 150 mg Hartkapsel, retardiert 15 mg Prolonged - 17

18 Dermapharm Aktiengesellschaft Lil-Dagover-Ring Grünwald Fexofenadine Fexofenaderm 120 mg Filmten 120 mg Film - coated Dermapharm Aktiengesellschaft Lil-Dagover-Ring Grünwald Fexofenadine Fexofenaderm 180mg Filmten 180 mg Film - coated Farmaprojects, S.A.U. Santa Eulalia, L'Hospitalet de Llobregat Barcelona Spain Venlafaxine Venlafaxin Farmaprojects 37,5 mg Hartkapseln, retardiert 37,5 mg Prolonged - Farmaprojects, S.A.U. Santa Eulalia, L'Hospitalet de Llobregat Barcelona Spain Venlafaxine Venlafaxin Farmaprojects 75 mg Hartkapseln, retardiert 75 mg Prolonged - Farmaprojects, S.A.U. Santa Eulalia, L'Hospitalet de Llobregat Barcelona Spain Venlafaxine Venlafaxin Farmaprojects 150 mg Hartkapseln, retardiert 150 mg Prolonged - 18

19 G.L. Pharma GmbH Schlossplatz Lannach Austria Nebivolol NEBITEN 5MG 5 mg Tablet Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Venlafaxine Venlafaxin Heumann 37,5 mg Hartkapseln, retardiert 37,5 mg Prolonged - Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Venlafaxine Venlafaxin Heumann 75 mg Hartkapseln, retardiert 75 mg Prolonged - Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Venlafaxine Venlafaxin Heumann 150 mg Hartkapseln, retardiert 150 mg Prolonged - Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Nebivolol Nebivolol Heumann 5 mg Tabletten 5 mg Tablet 19

20 Hormosan Pharma GmbH Wilhelmshoeher Str. 106 D Frankfurt 06 Hessen Levetiracetam Levetiracetam-Hormosan 500 mg Filmten 500 mg Film - coated Hormosan Pharma GmbH Wilhelmshoeher Str. 106 D Frankfurt 06 Hessen Levetiracetam Levetiracetam-Hormosan 750 mg Filmten 750 mg Film - coated Hormosan Pharma GmbH Wilhelmshoeher Str. 106 D Frankfurt 06 Hessen Levetiracetam Levetiracetam-Hormosan 1000 mg Filmten 1000 mg Film - coated Hormosan Pharma GmbH Wilhelmshoeher Str. 106 D Frankfurt 06 Hessen Levetiracetam Levetiracetam-Hormosan 250 mg Filmten 250 mg Film - coated Lannacher Heilmittel Ges.m.b.H. Schlossplatz Lannach Austria Nebivolol Nebivolol Lannacher 5 mg Tabletten 5 mg Tablet 20

21 ratiopharm GmbH Graf-Arco-Strasse 3 D Ulm Nebivolol NEBIVOLOL- RATIOPHARM 5mg 5 mg Tablet Torrent Pharma GmbH Südwestpark Nürnberg Nebivolol Nebivolol Torrent 5 mg Tabletten 5 mg Tablet Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma retard 37.5 mg Hartkapseln, retardiert 37,5 mg Prolonged - Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma retard 75 mg Hartkapseln, retardiert 75 mg Prolonged - Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma retard 150 mg hartkapseln, retardiert 150 mg Prolonged - Greece Pharmazac SA 31 Naoussis street Athens 1447 Greece Venlafaxine Zacalen pr cap 75mg/cap 75 mg Prolonged - 21

22 Greece Greece Hungary Hungary Hungary Hungary Pharmazac SA 31 Naoussis street Athens 1447 Greece Torrent Pharma GmbH Südwestpark Nürnberg Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Ewopharma International s.r.o., Hlavna 13 Bratislava Slovakia Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Venlafaxine Zacalen pr cap 150mg/cap 150 mg Prolonged - Nebivolol Nebivolol Torrent 5 mg 5 mg Tablet Venlafaxine Venlafaxin Bluefish mg Prolonged - mg nyújtott hatóanyagleadású kemény kapszula Fexofenadine Ewofex 180 mg 180 mg Film - coated filmta Fexofenadine Fexgen 120 mg 120 mg Film - coated filmta Fexofenadine Fexgen 180 mg 180 mg Film - coated filmta 22

23 Hungary Hungary Hungary Hungary Iceland Iceland Torrent Pharma GmbH Südwestpark Nürnberg Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Nebivolol Nebivolol Torrent 5 mg 5 mg Tablet Venlafaxine Venlagamma 37,5 mg 37,5 mg Prolonged - retard kemény kapszula Venlafaxine Venlagamma 75 mg 75 mg Prolonged - retard kemény kapszula Venlafaxine Venlagamma 150 mg 150 mg Prolonged - retard kemény kapszula Venlafaxine Venlafaxine Bluefish 150 mg Prolonged - hydrochloride Venlafaxine Venlafaxine Bluefish 37,5 mg Prolonged - hydrochloride 23

24 Iceland Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlafaxine Bluefish 75 mg Prolonged - Iceland Mylan AB PO Box SE Stockholm Fexofenadine Nefoxef 120 mg Film - coated Iceland Mylan AB PO Box SE Stockholm Fexofenadine Nefoxef 180 mg Film - coated Ireland Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlablue XL 75 mg, prolonged release capsules, 75 mg Prolonged - release capsule Ireland Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlablue XL 150 mg, prolonged release capsules, 150 mg Prolonged - release capsule Ireland Chanelle Medical Dublin road Loughrea, Co. Galway Ireland Fexofenadine hydrochloride Fexofenadine hydrochloride 120 mg Film-Coated s 120 mg Film - coated 24

25 Ireland Chanelle Medical Dublin road Loughrea, Co. Galway Ireland Fexofenadine hydrochloride Fexofenadine hydrochloride 180 mg Film-coated s 180 mg Film - coated Ireland Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Venlafaxine hydrochloride Vensir XL 75 mg prolonged-release capsules 75 mg Prolonged - release capsule Ireland Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Venlafaxine hydrochloride Vensir XL 150 mg prolonged-release capsules 150 mg Prolonged - release capsule Italy Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D Hamburg Levocetirizine Levcetin 5 mg compresse rivestite con film 5 mg Film - coated Italy Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine VENLAFAXINA ABC 75 mg Prolonged - Italy Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine VENLAFAXINA ABC 150 mg Prolonged - 25

26 Italy Italy Italy Italy Italy Italy Costanzafarma S.R.L. Via Taranto, Milan Italy Costanzafarma S.R.L. Via Taranto, Milan Italy FB Health S.p.A. Via dei Sabini, Ascoli Piceno Italy FB Health S.p.A. Via dei Sabini, Ascoli Piceno Italy Germed Pharma S.P.A. Via Cantu', 11 Cinisello Balsamo Milan Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Fexofenadine FIXODIN 120 mg Film - coated Fexofenadine FIXODIN 180 mg Film - coated Venlafaxine IXILANIA 75 mg Prolonged - Venlafaxine IXILANIA 150 mg Prolonged - Nebivolol NEBIVOLOLO GERMED 5 mg Scored Levetiracetam LEVETIRACETAM MYLAN 250 mg Film - coated GENERICS 26

27 Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Levetiracetam LEVETIRACETAM MYLAN GENERICS 750 mg Film - coated Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Levetiracetam LEVETIRACETAM MYLAN GENERICS 500 mg Film - coated Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Levetiracetam LEVETIRACETAM MYLAN GENERICS 1000 mg Film - coated Italy MylanS.P.A. Via Vittor Pisani, Milan Italy Fexofenadine FEXOFENADINA MYLAN GENERICS 120 mg Film - coated Italy MylanS.P.A. Via Vittor Pisani, Milan Italy Fexofenadine FEXOFENADINA MYLAN GENERICS 180 mg Film - coated Italy Pensa Pharma S.P.A. Via Rossellini Ippolito, Milan Italy Venlafaxine VENLAFAXINA PENSA 75 mg Prolonged - Italy Pensa Pharma S.P.A. Via Rossellini Ippolito, Milan Italy Venlafaxine VENLAFAXINA PENSA 150 mg Prolonged - 27

28 Italy Progefarm S.r.l. Largo Donegani 4/A Novara Italy Venlafaxine VENLAFAXINA PROGE FARM 75 mg Prolonged - Italy Progefarm S.r.l. Largo Donegani 4/A Novara Italy Venlafaxine VENLAFAXINA PROGE FARM 150 mg Prolonged - Italy Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, Milano Italy Venlafaxine VENLAFAXINA RANBAXY GENERICI 75 mg Prolonged - Italy Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, Milano Italy Venlafaxine VENLAFAXINA RANBAXY GENERICI 150 mg Prolonged - Italy Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, Milano Italy Lansoprazole Lansoprazolo Ranbaxy 15 mg capsule rigide gastroresistenti 15 mg Gastro - resistant Italy Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, Milano Italy Lansoprazole Lansoprazolo Ranbaxy 30 mg capsule rigide gastroresistenti 30 mg Gastro - resistant 28

29 Latvia G.L. Pharma GmbH Schlossplatz Lannach Austria Nebivolol Nebiten 5 mg Tablet Latvia Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine Venlafaxine Orion 37,5 mg Prolonged - Latvia Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine Venlafaxine Orion 75 mg Prolonged - Latvia Ranbaxy UK Ltd. 20 Balderton Street London W1K 6TL Untied Lansoprazole Lanobax 30 mg gastroresistant capsules, 30 mg Gastro - resistant Latvia Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Bosentan Bosentan Sandoz 62,5 mg Film - coated Latvia Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Bosentan Bosentan Sandoz 125 mg Film - coated 29

30 Latvia Latvia Lithuania UAB Norameda Meistru 8a Vilnius LT Lithuania UAB Norameda Meistru 8a Vilnius LT Lithuania G.L. Pharma GmbH Schlossplatz Lannach Austria Bosentan Bosentan Norameda 62,5 mg Film - coated Bosentan Bosentan Norameda 125 mg Film - coated Nebivolol Nebiten 5 mg Tablet Lithuania Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine Venlafaxine Orion 37,5 mg Prolonged - Lithuania Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine Venlafaxine Orion 75 mg Prolonged - Lithuania Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine Venlafaxine Orion 150 mg Prolonged - 30

31 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Torrent Pharma GmbH Südwestpark Nürnberg UAB Norameda Meistru 8a Vilnius LT Lithuania UAB Norameda Meistru 8a Vilnius LT Lithuania Lansoprazole LANOBAX 30 mg Gastro - resistant Bosentan Bosentan Sandoz 62,5 mg Film - coated Bosentan Bosentan Sandoz 125 mg Film - coated Nebivolol Nebivolol Torrent 5 mg 5 mg Tablet Bosentan Bosentan Norameda 62,5 mg Film - coated Bosentan Bosentan Norameda 125 mg Film - coated 31

32 Norway Norway Norway Norway Norway Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark Biofarm Sp. z o.o. ul. Wałbrzyska Poznaň Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlafaxin Bluefish 75 mg Prolonged - Venlafaxine Venlafaxin Bluefish 150 mg Prolonged - hydrochloride Metoclopramide Metoclopramide Orifarm 10 mg Tablet hydrochloride Fexofenadine Altifex 120 mg Film - coated hydrochloride Fexofenadine Altifex 180 mg Film - coated hydrochloride Levocetirizine Zyx 5 mg Film - coated Venlafaxine Venlafaxine Bluefish XL 75 mg Prolonged - 32

33 Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxine Bluefish XL 150 mg Prolonged - Celon Pharma S.A. Ogrodowa 2A, Kiełpin Łomianki, Bosentan Bosentan Celon 125 mg Film - coated Farmaceutyczna Spółdzielnia Pracy Galena Krucza Wrocław Fexofenadine hydrochloride Fexofast 120 mg 120 mg Film - coated Farmaceutyczna Spółdzielnia Pracy Galena Krucza Wrocław Fexofenadine hydrochloride Fexofast 180 mg 180 mg Film - coated Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Levetiracetam Levetiracetam-Generics 250 mg Film - coated Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Levetiracetam Levetiracetam-Generics 500 mg Film - coated 33

34 Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Levetiracetam Levetiracetam-Generics 750 mg Film - coated Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Levetiracetam Levetiracetam-Generics 1000 mg Film - coated Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Fexofenadine FexoGen 120 mg Film - coated Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Fexofenadine FexoGen 180 mg Film - coated Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine Oriven 37,5 mg Prolonged - Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine Oriven 75 mg Prolonged - 34

35 Orion Corporation Orion Pharma PO BOX Espoo Finland Venlafaxine Oriven 150 mg Prolonged - Ranbaxy () Sp. z o.o. Kubickiego Warszawa Lansoprazole LANBAX 15 mg Gastro - resistant Ranbaxy () Sp. z o.o. Kubickiego Warszawa Lansoprazole LANBAX 30 mg Gastro - resistant Ranbaxy () Sp. z o.o. Kubickiego Warszawa Venlafaxine Venlabax MR 37,5 mg Prolonged - release capsule Ranbaxy () Sp. z o.o. Kubickiego Warszawa Venlafaxine Venlabax MR 75 mg Prolonged - release capsule Ranbaxy () Sp. z o.o. Kubickiego Warszawa Venlafaxine Venlabax MR 150 mg Prolonged - release capsule 35

36 Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria Bosentan Bosentan Sandoz 62,5 mg Film - coated Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria Bosentan Bosentan Sandoz 125 mg Film - coated Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 75 mg Prolonged - Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 37,5 mg Prolonged - Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 150 mg Prolonged - Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska Starogard Gdański Fexofenadine hydrochloride Telfexo 120 mg 120 mg Film - coated 36

37 Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska Starogard Gdański Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo Coimbra Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo Coimbra Fexofenadine hydrochloride Telfexo 180 mg 180 mg Film - coated Venlafaxine Venlafaxina Bluefish XR 75 mg Prolonged - Venlafaxine Venlafaxina Bluefish XR 150 mg Prolonged - Venlafaxine Venlafaxina Bluepharma 150 mg Prolonged - Venlafaxine Venlafaxina Bluepharma 75 mg Prolonged - 37

38 Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo Coimbra Eurogenus Farmacêutica, Sociedade Unipessoal, Lda. Rua Alto do Montijo, 13-2º Dto., Edifício Monsanto Carnaxide Eurogenus Farmacêutica, Sociedade Unipessoal, Lda. Rua Alto do Montijo, 13-2º Dto., Edifício Monsanto Carnaxide Eurogenus Farmacêutica, Sociedade Unipessoal, Lda. Rua Alto do Montijo, 13-2º Dto., Edifício Monsanto Carnaxide Generis Farmacêutica, S. A. Rua João de Deus, Amadora Venlafaxine Venlafaxina Bluepharma 37,5 mg Prolonged - Venlafaxine Venlafaxina Eurogenus 37,5 mg Prolonged - Venlafaxine Venlafaxina Eurogenus 75 mg Prolonged - Venlafaxine Venlafaxina Eurogenus 150 mg Prolonged - Nebivolol Nebivolol Generis 5 mg 38

39 Generis Farmacêutica, S. A. Rua João de Deus, Amadora Generis Farmacêutica, S. A. Rua João de Deus, Amadora Germed Farmacêutica, Lda. Rua Alto do Montijo, 13-1º Dto - Edifício Monsanto Portela de Carnaxide Portela de Carnaxide " GP - Genéricos Portugueses, Lda. Rua Henrique Paiva Couceiro, 29 - Venda Nova Amadora Labesfal, Genéricos, S.A. Av. Dr. Afonso Costa, nº Campo de Besteiros Nebivolol Nebivolol Inventis 5 mg Fexofenadine Fexofenadina Generis 180 mg Film - coated Nebivolol Nebivolol Germed 5 mg Tablet Nebivolol Nebivolol GP 5 mg Venlafaxine Venlafaxina Labesfal 37,5 mg Prolonged - oral use hydrochloride release 39

40 Labesfal, Genéricos, S.A. Av. Dr. Afonso Costa, nº Campo de Besteiros Labesfal, Genéricos, S.A. Av. Dr. Afonso Costa, nº Campo de Besteiros Labesfal, Genéricos, S.A. Av. Dr. Afonso Costa, nº Campo de Besteiros Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote C e Lisboa Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote C e Lisboa Venlafaxine hydrochloride Venlafaxina Labesfal 75 mg Prolonged - release oral use Venlafaxine Venlafaxina Labesfal 150 mg Prolonged - oral use hydrochloride release Nebivolol Nebivolol Labesfal 5 mg Fexofenadine Fexofenadina Mylan 120 mg Film - coated Fexofenadine Fexofenadina Mylan 180 mg Film - coated 40

41 Romania Romania Romania Romania Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso Porto Salvo Ewopharma International s.r.o., Hlavna 13 Bratislava Slovakia Ewopharma International s.r.o., Hlavna 13 Bratislava Slovakia Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Nebivolol Nebivolol Ratiopharm 5 mg Tablet Fexofenadine Ewofex 120 mg 120 mg Film - coated hydrochloride comprimate filmate Fexofenadine Ewofex 180 mg 180 mg Film - coated hydrochloride comprimate filmate Lansoprazole LEVANT 15 mg Gastro - resistant Lansoprazole LEVANT 30 mg Gastro - resistant 41

42 Romania Terapia SA Str. Fabricii nr. 124 Cluj Napoca România Venlafaxine Venlafaxina Terapia 37.5 mg capsule cu eliberare prelungită 37,5 mg Prolonged - Romania Terapia SA Str. Fabricii nr. 124 Cluj Napoca România Venlafaxine Venlafaxina Terapia 75 mg capsule cu eliberare prelungită 75 mg Prolonged - Romania Terapia SA Str. Fabricii nr. 124 Cluj Napoca România Venlafaxine Venlafaxina Terapia 150 mg capsule cu eliberare prelungită 150 mg Prolonged - Romania Torrent Pharma SRL Str. Stirbei Voda nr. 36 et. 2, biroul A, sector 1 Bucharest Romania Nebivolol Nebivolol Torrent com primate 5 mg Tablet Romania Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 37,5 mg capsule cu eliberare prelungita 37,5 mg Prolonged - Romania Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 75 mg capsule cu eliberare prelungita 75 mg Prolonged - 42

43 Romania Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 150 mg capsule cu eliberare prelungita 150 mg Prolonged - Slovak Republic Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxine Bluefish XR 75 mg tvrdé kapsuly s predĺženým uvoľňovaním 75 mg Prolonged - Slovak Republic Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxine Bluefish XR 150 mg tvrdé kapsuly s predĺženým uvoľňovaním 150 mg Prolonged - Slovak Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Fexofenadine Fexofenadin Generics 120 mg 120 mg Film - coated Slovak Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Fexofenadine Fexofenadin Generics 180 mg 160 mg Film - coated Slovak Republic Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 37,50 mg 37,5 mg Prolonged - 43

44 Slovak Republic Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 75 mg 75 mg Prolonged - Slovak Republic Wörwag Pharma GmbH & Co. KG Calwer Str Böblingen Venlafaxine Venlagamma 150 mg 150 mg Prolonged - Slovenia Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Levetiracetam Lyvam 250 mg filmsko obložene e 250 mg Film - coated Slovenia Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Levetiracetam Lyvam 500 mg filmsko obložene e 500 mg Film - coated Slovenia Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Levetiracetam Lyvam 750 mg filmsko obložene e 750 mg Film - coated Slovenia Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Levetiracetam Lyvam 1000 mg filmsko obložene e 1000 mg Film - coated 44

45 Slovenia Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Bosentan Bosentan Sandoz 62,5 mg filmsko obložene e 62,5 mg Film - coated Slovenia Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Bosentan Bosentan Sandoz 125 mg filmsko obložene e 125 mg Film - coated Slovenia UAB Norameda Meistru 8a Vilnius LT Lithuania Bosentan Bosentan Norameda 125 mg filmsko obložene e 125 mg Film - coated Slovenia UAB Norameda Meistru 8a Vilnius LT Lithuania Bosentan Bosentan Norameda 62,5 mg filmsko obložene e 62,5 mg Film - coated Spain Aristo Pharma Iberia, S.L, c/ Solana, 26, Torrejon de Ardoz, Madrid, Spain Nebivolol Nebivolol Edigen 5 mg comprimidos efg 5 mg Tablet Spain Aristo Pharma Iberia, S.L, c/ Solana, 26, Torrejon de Ardoz, Madrid, Spain Venlafaxine Venlafaxina Retard Urlabs 150 mg capsulas duras de liberacion prolongada efg 150 mg Prolonged - 45

46 Spain Aristo Pharma Iberia, S.L, c/ Solana, 26, Torrejon de Ardoz, Madrid, Spain Venlafaxine Venlafaxina Retard Urlabs 75 mg capsulas duras de liberacion prolongada efg 75 mg Prolonged - Spain Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxina Bluefish 150 mg capsulas de liberacion prolongada efg 150 mg Prolonged - release capsule Spain Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxina Bluefish 75 mg capsulas de liberacion prolongada efg 75 mg Prolonged - release capsule Spain Laboratorios Ranbaxy, S. L U. Paseig de Gracia 9 7a Pl Barcelona Spain Venlafaxine Venlafaxina Retard Ranbaxygen 75 mg capsulas duras de liberacion prolongada efg 75 mg Prolonged - Spain Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF Levetiracetam Levetiracetam Lupin 750 mg comprimidos recubiertos con pelicula efg 750 mg Film - coated Spain Pharmagenus, S.A., Avda. Camí Real, 51-57, Palau-solita i Plegamans (Barcelona) Spain Venlafaxine Venlafaxina Retard Pharmagenus 150 mg capsulas duras de liberacion prolongada efg 150 mg Prolonged - 46

47 Spain Pharmagenus, S.A., Avda. Camí Real, 51-57, Palau-solita i Plegamans (Barcelona) Spain Venlafaxine Venlafaxina Retard Pharmagenus 75 mg capsulas duras de liberacion prolongada efg 75 mg Prolonged - Spain RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta Alcobendas (Madrid) Spain Nebivolol Nebivolol Ratio 5 mg comprimidos efg 5 mg Tablet Spain Teva Pharma S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta Madrid Spain Fexofenadine Fexofenadina Tevagen 120 mg comprimidos recubiertos con pelicula efg 120 mg Film - coated Spain Teva Pharma S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta Madrid Spain Fexofenadine Fexofenadina Tevagen 180 mg comprimidos recubiertos con pelicula efg 180 mg Film - coated Spain Welding GmbH & Co. KG Esplanade 39 D Hamburg Levetiracetam Levetiracetam Lupin 1000 mg comprimidos recubiertos con pelicula efg 1000 mg Film - coated 47

48 Spain Spain Welding GmbH & Co. KG Esplanade 39 D Hamburg Welding GmbH & Co. KG Esplanade 39 D Hamburg Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Levetiracetam Levetiracetam Lupin 250 mg comprimidos recubiertos con pelicula efg 250 mg Film - coated Levetiracetam Levetiracetam Lupin mg Film - coated mg comprimidos recubiertos con pelicula efg Bendroflumethiazide Bendroflumetiazid 2,5 mg Tablet Alternova Bendroflumethiazide Bendroflumetiazid 5 mg Tablet Alternova Venlafaxine Venlafaxin Bluefish 37,5 mg Prolonged - hydrochloride Venlafaxine Venlafaxin Bluefish 75 mg Prolonged - hydrochloride Venlafaxine Venlafaxin Bluefish 150 mg Prolonged - hydrochloride 48

49 Mylan AB PO Box SE Stockholm Mylan AB PO Box SE Stockholm Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark Orifarm Generics A/S PO BOX 69 DK-5260 Odense S Denmark Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Fexofenadine Nefoxef 120 mg Film - coated Fexofenadine Nefoxef 160 mg Film - coated Metoclopramide Metoclopramide Orifarm 10 mg Tablet hydrochloride Fexofenadine Altifex 120 mg Film - coated hydrochloride Fexofenadine Altifex 180 mg Film - coated hydrochloride Venlafaxine Venlafaxin Ranbaxy 150 mg Prolonged mg depotkapsel, hård 49

50 Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Venlafaxine Venlafaxin Ranbaxy 75 mg depotkapsel, hård 75 mg Prolonged - The Netherlands Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D Hamburg Levocetirizine Levocetira 5 mg filmomhulde 5 mg Film - coated The Netherlands Apothecon B.V. Nijverheidsweg ME Barneveld The Netherlands Fexofenadine Fexofenadine HCL 120 A, filmomhulde ten 120 mg 120 mg Film - coated The Netherlands Apothecon B.V. Nijverheidsweg ME Barneveld The Netherlands Fexofenadine Fexofenadine HCL 180 A, filmomhulde ten 120 mg 180 mg Film - coated The Netherlands Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxine Bluefish 37,5 mg, capsules met verlengde afgifte, 37,5 mg Prolonged - The Netherlands Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxine Bluefish 37,5 mg, capsules met verlengde afgifte, 75 mg Prolonged - 50

51 The Netherlands Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine Venlafaxine Bluefish 37,5 mg, capsules met verlengde afgifte, 150 mg Prolonged - The Netherlands Farmaprojects, S.A.U. Santa Eulalia, L'Hospitalet de Llobregat Barcelona Spain Venlafaxine Venlafaxine Farmaprojects 37,5 mg, capsules met verlengde afgifte, 37,5 mg Prolonged - The Netherlands Farmaprojects, S.A.U. Santa Eulalia, L'Hospitalet de Llobregat Barcelona Spain Venlafaxine Venlafaxine Farmaprojects 75 mg, capsules met verlengde afgifte, 75 mg Prolonged - The Netherlands Farmaprojects, S.A.U. Santa Eulalia, L'Hospitalet de Llobregat Barcelona Spain Venlafaxine Venlafaxine Farmaprojects 150 mg, capsules met verlengde afgifte, 150 mg Prolonged - The Netherlands Mylan B.V. Dieselweg LB Bunschoten The Netherlands Fexofenadine Fexofenadine HCL Mylan 120 mg, filmomhulde ten 120 mg Film - coated The Netherlands Mylan B.V. Dieselweg LB Bunschoten The Netherlands Fexofenadine Fexofenadine HCL Mylan 180 mg, filmomhulde ten 180 mg Film - coated 51

52 The Netherlands Pharmachemie B.V. Swensweg GA Haarlem The Netherlands Fexofenadine Fexofenadine HCl 120 PCH, filmomhulde ten 120 mg 120 mg Film - coated The Netherlands Pharmachemie B.V. Swensweg GA Haarlem The Netherlands Fexofenadine Fexofenadine HCl 180 PCH, filmomhulde ten 120 mg 180 mg Film - coated The Netherlands Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Lansoprazole Lansoprazol Ranbaxy 15 mg, maagsapresistente capsules 15 mg Gastro - resistant The Netherlands Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Lansoprazole Lansoprazol Ranbaxy 30 mg, maagsapresistente capsules 30 mg Gastro - resistant The Netherlands Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Venlafaxine Venlafaxine Ranbaxy 75 mg, capsules met verlengde afgifte 75 mg Prolonged - The Netherlands Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE Untied Venlafaxine Venlafaxine Ranbaxy 150 mg, capsules met verlengde afgifte 150 mg Prolonged - 52

53 The Netherlands ratiopharm Nederland B.V. Swensweg GA Haarlem The Netherlands Fexofenadine Fexofenadine HCl ratiopharm 120 mg, filmomhulde ten 120 mg Film - coated Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlablue XL 37.5mg Prolonged Release Capsules Hard 37,5 mg Prolonged - Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlablue XL 75mg Prolonged Release Capsules Hard 75 mg Prolonged - Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Venlafaxine hydrochloride Venlablue XL 150mg Prolonged Release Capsules Hard 150 mg Prolonged - Chanelle Medical Dublin road Loughrea, Co. Galway Ireland Fexofenadine Fexofenadine 120mg film-coated s 120 mg Film - coated Chanelle Medical Dublin road Loughrea, Co. Galway Ireland Fexofenadine Fexofenadine 180mg film-coated s 180 mg Film - coated 53

54 Forum Products Limted Crown House 2-8 Gloucester Road Redhill Surrey RH1 1FH Venlafaxine hydrochloride Foraven XL 75mg Modified Release Capsules 75 mg Modified - release capsule, Forum Products Limted Crown House 2-8 Gloucester Road Redhill Surrey RH1 1FH Venlafaxine hydrochloride Foraven XL 150mg Modified Release Capsules 150 mg Modified - release capsule, Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Fexofenadine Fexofenadine hydrochloride 120mg Film-coated s 120 mg Film - coated Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Fexofenadine Fexofenadine hydrochloride 180mg Film-coated s 180 mg Film - coated Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF Levetiracetam Levetiracetam Lupin 250mg Film-coated s 250 mg Film - coated Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF Levetiracetam Levetiracetam Lupin 500mg Film-coated s 500 mg Film - coated 54

55 Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF Levetiracetam Levetiracetam Lupin 750mg Film-coated s 750 mg Film - coated Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF Levetiracetam Levetiracetam Lupin 1000mg Film-coated s 1000 mg Film - coated Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Venlafaxine hydrochloride Vensir XL 75mg Prolonged Release Hard Capsules 75 mg Prolonged - Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Venlafaxine hydrochloride Vensir XL 150mg Prolonged Release Hard Capsules 150 mg Prolonged - Teva UK Limited Brampton Road Hampden Park Sussex BN22 9AG Fexofenadine Fexofenadine 120mg film-coated s 120 mg Film - coated 55

56 Teva UK Limited Brampton Road Hampden Park Sussex BN22 9AG Fexofenadine Fexofenadine 180mg film-coated s 180 mg Film - coated 56

57 Annex IB: Products for which the marketing authorisations are recommended for suspension Member State Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Esomeprazole magnesium Esomeprazol Arcana 20 mg magensaftresistente Hartkapseln 20 mg Gastro - resistant capsule, Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Esomeprazole magnesium Esomeprazol Arcana 40 mg magensaftresistente Hartkapseln 40 mg Gastro - resistant capsule, Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Esomeprazole magnesium Neximyl 20 mg magensaftresistente Hartkapseln 20 mg Gastro - resistant capsule, Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Esomeprazole magnesium Neximyl 40 mg magensaftresistente Hartkapseln 40 mg Gastro - resistant capsule, Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Candesartan cilexetil Candesartan Arcana 4mg Tabletten 4 mg Tablet Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Candesartan cilexetil Candesartan Arcana 8mg Tabletten 8mg Tablet 57

58 Austria Austria Austria Austria Austria Belgium Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Genericon Pharma GmbH Hafnerstr Graz Austria ratiopharm Arzneimittei- Vertriebs-GmbH Albert-Schweitzer-Gasse Wien Austria ratiopharm Arzneimittei- Vertriebs-GmbH Albert-Schweitzer-Gasse Wien Austria Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Netherlands Candesartan cilexetil Candesartan Arcana 16mg Tabletten 16 mg Tablet Candesartan Candesartan Arcana 32mg 32 mg Tablet cilexetil Tabletten Nebivolol Nebivolol Genericon 5 mg 5 mg Tablet Tabletten Desloratadine Desloratadin ratiopharm 2,5 mg Orodispersible 2,5 mg Schmelzten Desloratadine Desloratadin ratiopharm 5 5 mg Orodispersible mg Schmelzten Desloratadine Desloratadine Apotex 5 mg Film - coated 58

59 Belgium Belgium Belgium Belgium Belgium Belgium Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Donepezil Donepezil Odis Mylan 5 mg Orodispersible Donepezil Donepezil Odis Mylan 10 mg Orodispersible Repaglinide Repaglinide Mylan 0,5 mg 0,5 mg Tablet Pharma Repaglinide Repaglinide Mylan 1 mg 1 mg Tablet Pharma Repaglinide Repaglinide Mylan 2mg 2 mg Tablet Pharma Candesartan Candesartan Mylan 8 mg Tablet Candesartan Candesartan Mylan 16 mg Tablet 59

60 Belgium Belgium Belgium Belgium Belgium Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Takeda Belgium Gentsesteenweg Brussels Belgium Teva Pharma Belgium NV Laarstraat Wilrijk Belgium Teva Pharma Belgium NV Laarstraat Wilrijk Belgium Candesartan Candesartan Mylan 32 mg Tablet Esomeprazole Esomeprazole Mylan 20 mg Gastro - resistant capsule, Esomeprazole Esomeprazole Mylan 40 mg Gastro - resistant capsule, Alendronic acid Alendromono 70 mg Tablet Desloratadine Desloratadine Teva 2,5 mg Orodispersible Desloratadine Desloratadine Teva 5 mg Orodispersible 60

61 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Ropinirole Ropinirole Accord 0,5 mg Film - coated Ropinirole Ropinirole Accord 1 mg Film - coated Ropinirole Ropinirole Accord 2 mg Film - coated Ropinirole Ropinirole Accord 5 mg Film - coated Cefpodoxime FOXERO 200 mg Tablet 61

62 Bulgaria Aquachim AD blvd. Prof. Tsvetan Lazarov 83 Sofia 1582 Bulgaria Quetiapine Aquatiapine 25 mg Film - coated Bulgaria Aquachim AD blvd. Prof. Tsvetan Lazarov 83 Sofia 1582 Bulgaria Quetiapine Aquatiapine 100 mg Film - coated Bulgaria Aquachim AD blvd. Prof. Tsvetan Lazarov 83 Sofia 1582 Bulgaria Quetiapine Aquatiapine 200 mg Film - coated Bulgaria Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Esomeprazole magnesium Esopragen 20 mg Gastro - resistant capsule, Bulgaria Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Esomeprazole magnesium Esopragen 40 mg Gastro - resistant capsule, Bulgaria Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b Praha 4 Czech Republic Trimetazidine Apstar 35 mg prolonged-release s 35 mg Prolonged - release 62

63 Bulgaria Mylan SAS 117 allée des Parcs Saint-Priest Cedex Trimetazidine Trimetazigen MR 35 mg Prolonged - release Bulgaria Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Trimetazidine Energotrim 35 mg Prolonged - release Bulgaria Tchaikapharma Highquality Medicines 1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria Bosentan Pulmohyperta 62,5 mg Film - coated Bulgaria Tchaikapharma Highquality Medicines 1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria Bosentan Pulmohyperta 125 mg Film - coated Croatia Alkaloid d.o.o. Ulica grada Vukovara 226 F Zagreb Croatia Cefpodoxime Rexocef 200 mg filmom obložene e 200 mg Film - coated Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica Croatia Desloratadine Alerdin 2,5 mg raspadljive e za usta 2,5 mg Orodispersible 63

64 Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica Croatia Desloratadine Alerdin 5 mg raspadljive e za usta 5 mg Orodispersible Croatia Fidifarm d.o.o. Obrtnička 37, Bestovje Rakitje Croatia Desloratadine Sinalerg 5 mg filmom obložene e 5 mg Film - coated Croatia Jadran Galenski Laboratorij d.d. Svilno 20, Rijeka Croatia Desloratadine Escontral direkt 2,5 mg raspadljiva a za usta 2,5 mg Orodispersible Croatia Jadran Galenski Laboratorij d.d. Svilno 20, Rijeka Croatia Desloratadine Escontral direkt 5 mg raspadljiva a za usta 5 mg Orodispersible Croatia PharmaS d.o.o. Radnička cesta 47 Zagreb Croatia Tramadol/paraceta mol Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene e 37,5 mg/325 mg Film - coated Croatia PharmaS d.o.o. Radnička cesta 47 Zagreb Croatia Escitalopram Escitalopram PharmaS 10 mg filmom obložene e 10 mg Film - coated 64