List of nationally authorised medicinal products

Transcription

1 24 January 2018 EMA/270645/2015 Human Medicines Evaluation Division Active substance: azithromycin (systemic use formulations) Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 3Z, 150 mg, pó para suspensão oral National Number not available JABA RECORDATI, S.A. PT 3Z, 200 mg, pó para suspensão oral not available JABA RECORDATI, S.A. PT 3Z, 250 mg, pó para suspensão oral not available JABA RECORDATI, S.A. PT 3Z, 500 mg, pó para suspensão oral not available JABA RECORDATI, S.A. PT 3Z, 500 mg, pó para suspensão oral not available JABA RECORDATI, S.A. PT AZADOSE 600 mg, comprimé pelliculé not available PFIZER HOLDING FRANCE FR AZADOSE 600 mg, comprimé pelliculé not available PFIZER HOLDING FRANCE FR AZADOSE 600 mg, comprimé pelliculé not available PFIZER HOLDING FRANCE FR AZADOSE 600 mg, comprimé pelliculé not available PFIZER HOLDING FRANCE FR AZADOSE 600 mg, comprimé pelliculé not available PFIZER HOLDING FRANCE FR EMA/24970/2018 Page 2/30

3 AZADOSE 600 mg, comprimé pelliculé National Number not available PFIZER HOLDING FRANCE FR Azatril 250 mg, filmcoated tablets NL/H/2400/ /2012/01-04 ACTAVIS GROUP PTC EHF. RO Azibiot 20 mg/ml milteliai geriamajai suspensijai SK/H/0148/003 LT/1/14/3600/003 KRKA, D.D., NOVO MESTO LT Azibiot 20 mg/ml pulbere pentru suspensie orală SK/H/0148/ /2017/01 KRKA, D.D., NOVO MESTO RO Azibiot NEO 20 mg/ml prášok na perorálnu suspenziu Azibiot, 20 mg/ml, proszek do sporządzania zawiesiny doustnej Azithromycin 250 mg Capsules SK/H/0148/003 15/0001/17-S KRKA, D.D., NOVO MESTO SK SK/H/0148/ KRKA, D.D., NOVO MESTO PL not available PL 42357/0224 AMNEAL PHARMA EUROPE UK LIMITED Azithromycin 250mg Tablets AT/H/0266/001 PL 04416/1235 SANDOZ LTD UK Azithromycin 500mg Tablets DE/H/1903/002 PL 04416/0668 SANDOZ LTD UK EMA/24970/2018 Page 3/30

4 Azithromycin Actavis 250 mg filmom obalené tablety Azithromycin Aurovitas 250 mg potahované tablety Azithromycin Aurovitas 500 mg potahované tablety Azithromycin Hexal 250 mg - Filmtabletten National Number NL/H/2400/001 15/0480/12-S ACTAVIS GROUP PTC EHF. SK PT/H/1475/001 15/481/16-C AUROVITAS UNIPESSOAL, LDA. PT/H/1475/002 15/482/16-C AUROVITAS UNIPESSOAL, LDA. AT/H/0266/ HEXAL PHARMA GMBH AT CZ CZ Azithromycin Krka 20 mg/ml pulveris iekšķīgi lietojamas suspensijas pagatavošanai Azithromycin Krka, 20 mg/ml suukaudse suspensiooni pulber Azithromycin Sandoz 100 mg/ 5 ml prášok na perorálnu suspenziu Azithromycin Sandoz 500 mg Filmtabletten SK/H/0148/ KRKA, D.D., NOVO MESTO LV SK/H/0148/ KRKA, D.D., NOVO MESTO EE NL/H/0886/001 15/0181/07-S SANDOZ PHARMACEUTICALS SK D.D. DE/H/1903/ SANDOZ GMBH AT Azithromycin Sandoz 500 mg - Granulat zur Herstellung einer AT/H/0390/ SANDOZ GMBH AT EMA/24970/2018 Page 4/30

5 Suspension zum Einnehmen auf einem Messlöffel Azithromycin Sandoz 500 mg plèvele dengtos tabletès Azithromycin Sandoz 500 mg plèvele dengtos tabletès Azithromycin Sandoz 500 mg plèvele dengtos tabletès Azithromycin Sandoz 500 mg plèvele dengtos tabletès Azithromycin Sandoz 500 mg plèvele dengtos tabletès Azithromycin Sandoz 500 mg plèvele dengtos tabletès Azithromycin Sandoz 500 mg plèvele dengtos tabletès Azithromycin Sandoz 500 mg plèvele dengtos tabletès National Number DE/H/1903/002 LT/1/05/0323/007 SANDOZ GMBH LT DE/H/1903/002 LT/1/05/0323/010 SANDOZ GMBH LT DE/H/1903/002 LT/1/05/0323/008 SANDOZ GMBH LT DE/H/1903/002 LT/1/05/0323/009 SANDOZ GMBH LT DE/H/1903/002 LT/1/05/0323/011 SANDOZ GMBH LT DE/H/1903/002 LT/1/05/0323/012 SANDOZ GMBH LT DE/H/1903/002 LT/1/05/0323/013 SANDOZ GMBH LT DE/H/1903/002 LT/1/05/0323/014 SANDOZ GMBH LT EMA/24970/2018 Page 5/30

6 AZITHROMYCINE MONODOSE SANDOZ 250 mg, comprimé pelliculé AZITHROMYCINE SANDOZ 250 mg, comprimé pelliculé AZITHROMYCINE SANDOZ 250 mg, comprimé pelliculé AZITHROMYCINE SANDOZ 250 mg, comprimé pelliculé AZITHROMYCINE SANDOZ 250 mg, comprimé pelliculé Azitromax 2 g depotgranulat till oral suspension Azitromax 250 mg filmdragerade tabletter National Number not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available PFIZER AB SE not available PFIZER AB SE Azitromax 40 mg/ml pulver till oral suspension not available PFIZER AB SE Azitromax 40 mg/ml, pulver til mikstur, suspensjon not available 8025 PFIZER AS NO EMA/24970/2018 Page 6/30

7 Azitromax 500 mg filmdragerade tabletter National Number not available PFIZER AB SE Azitromax 500 mg tabletter not available PFIZER AS NO Azitromax 500 mg, pulver till koncentrat till infusionsvätska, lösning Azitromax 600 mg filmdragerade tabletter not available PFIZER AB SE not available PFIZER AB SE Azitromicin Krka 20 mg/ml prašek za peroralno suspenzijo AZITROMICINA PFIZER 100 mg polvere per sospensione orale AZITROMICINA PFIZER 150 mg polvere per sospensione orale AZITROMICINA PFIZER 200 mg polvere per sospensione orale AZITROMICINA PFIZER 200 mg/5 ml polvere per sospensione orale SK/H/0148/003 H/14/00246/006 KRKA, D.D., NOVO MESTO SI not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT EMA/24970/2018 Page 7/30

8 AZITROMICINA PFIZER 200 mg/5 ml polvere per sospensione orale AZITROMICINA PFIZER 250 mg capsule rigide National Number not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT AZITROMICINA PFIZER 300 mg polvere per sospensione orale AZITROMICINA PFIZER 400 mg polvere per sospensione orale AZITROMICINA PFIZER 500 mg compresse rivestite con film AZITROMICINA PFIZER 500 mg polvere per soluzione per infusione AZITROMICINA PFIZER Avium 600 mg compresse rivestite con film Azitromicină Sandoz 500 mg, granule pentru suspensie orală în linguriță unidoză Azitromicina Teva 250 mg compresse rivestite con film not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT AT/H/0390/ /2012/01 S.C. SANDOZ S.R.L. RO NL/H/0614/ TEVA ITALIA S.R.L. IT EMA/24970/2018 Page 8/30

9 Azitromicina Teva 250 mg compresse rivestite con film Azitromicina Teva 250 mg compresse rivestite con film Azitromicina Teva 250 mg compresse rivestite con film Azitromicina TEVA 250 mg comprimidos recubiertos con pelicula EFG Azitromycine Sandoz 100 mg/5 ml, poeder voor orale suspensie ORDIPHA 500 mg, comprimé dispersible sécable ORDIPHA 500 mg, comprimé dispersible sécable Ribotrex 200 mg/5 ml polvere per sospensione orale Ribotrex 500 mg compresse rivestite con film National Number NL/H/0614/ TEVA ITALIA S.R.L. IT NL/H/0614/ TEVA ITALIA S.R.L. IT NL/H/614/ TEVA ITALIA S.R.L. IT NL/H/0614/ TEVA PHARMA S.L.U ES NL/H/0886/001 RVG SANDOZ B.V. NL not available TONIPHARM FR not available TONIPHARM FR not available PIERRE FABRE PHARMA S.R.L. not available PIERRE FABRE PHARMA S.R.L. IT IT EMA/24970/2018 Page 9/30

10 SUMAMED 100 mg/5 ml milteliai geriamajai suspensijai Sumamed 100 mg/5 ml por sziruphoz National Number not available LT/1/94/0529/005 TEVA PHARMA B.V. LT not available OGYI-T-5272/03 TEVA GYÓGYSZERGYÁR ZRT HU Sumamed 100 mg/5 ml prašak za oralnu suspenziju Sumamed 100 mg/5 ml pulveris iekšķīgi lietojamas suspensijas pagatavošanai Sumamed 100 mg/ml por oldatos infúzióhoz való koncentrátumhoz Sumamed 1200, 200 mg/5 ml prašak za oralnu suspenziju Sumamed 125 mg comprimate filmate not available HR-H PLIVA HRVATSKA D.O.O. HR not available TEVA PHARMA B.V. LV not available OGYI-T-5272/07 TEVA GYÓGYSZERGYÁR ZRT HU not available HR-H PLIVA HRVATSKA D.O.O. HR not available 8765/2016/01 PLIVA LJUBLJANA D.O.O.; RO Sumamed 125 mg filmom obalené tablety not available 15/0351/92-C/S TEVA PHARMACEUTICALS SLOVAKIA S.R.O SK Sumamed 125 mg filmom obložene tablete not available HR-H PLIVA HRVATSKA D.O.O. HR EMA/24970/2018 Page 10/30

11 SUMAMED 125 mg filmsko obložene tablete National Number not available H/92/01472/001 PLIVA LJUBLJANA D.O.O.; SI SUMAMED 125 mg potahované tablety not available A-C TEVA PHARMACEUTICALS CR, S.R.O. CZ Sumamed 1500, 200 mg/5 ml prašak za oralnu suspenziju Sumamed 250 mg capsule not available HR-H PLIVA CROATIA LTD HR not available 730/2008/01 PLIVA LJUBLJANA D.O.O.; RO Sumamed 250 mg cietās kapsulas not available TEVA PHARMA B.V. LV SUMAMED 250 mg kapsule not available HR-H TEVA B.V HR Sumamed 250 mg kemény kapszula not available OGYI-T-5272/04 TEVA GYÓGYSZERGYÁR ZRT HU Sumamed 250 mg kietosios kapsulės not available LT/1/94/0529/002 TEVA PHARMA B.V. LT SUMAMED 250 mg trde kapsule not available H/92/01472/002 PLIVA LJUBLJANA D.O.O.; SI EMA/24970/2018 Page 11/30

12 SUMAMED 40 mg/ml prašek za peroralno suspenzijo Sumamed 500 mg apvalkotas tabletes National Number not available H/92/01472/006 PLIVA LJUBLJANA D.O.O.; SI not available TEVA PHARMA B.V. LV Sumamed 500 mg comprimate filmate not available 8766/2016/01 PLIVA LJUBLJANA D.O.O.; RO Sumamed 500 mg filmom obalené tablety not available 15/0351/92-C/S TEVA PHARMACEUTICALS SLOVAKIA S.R.O SK Sumamed 500 mg filmom obložene tablete not available HR-H PLIVA CROATIA LTD HR SUMAMED 500 mg filmsko obložene tablete not available H/92/01472/003 PLIVA LJUBLJANA D.O.O.; SI Sumamed 500 mg filmtabletta not available OGYI-T-5272/05 TEVA GYÓGYSZERGYÁR ZRT HU SUMAMED 500 mg infuze prášek pro infuzní roztok not available 15/223/03-C TEVA PHARMACEUTICALS CR, S.R.O. CZ Sumamed 500 mg plėvele dengtos tabletės not available LT/1/94/0529/004 TEVA PHARMA B.V. LT EMA/24970/2018 Page 12/30

13 Sumamed 500 mg plėvele dengtos tabletės National Number not available LT/1/94/0529/003 TEVA PHARMA B.V. LT SUMAMED 500 mg potahované tablety not available 15/351/92-B/C TEVA PHARMACEUTICALS CR, S.R.O. CZ Sumamed 500 mg prašak za koncentrat za otopinu za infuziju SUMAMED 500 mg prašek za raztopino za infundiranje Sumamed forte 200 mg/5 ml milteliai geriamajai suspensijai Sumamed forte 200 mg/5 ml milteliai geriamajai suspensijai Sumamed forte 200 mg/5 ml milteliai geriamajai suspensijai Sumamed forte 200 mg/5 ml por sziruphoz not available HR-H PLIVA HRVATSKA D.O.O. HR not available H/92/01472/007 PLIVA LJUBLJANA D.O.O.; SI not available LT/1/94/0529/007 TEVA PHARMA B.V. LT not available LT/1/94/0529/006 TEVA PHARMA B.V. LT not available LT/1/94/0529/008 TEVA PHARMA B.V. LT not available OGYI-T-5272/02 TEVA GYÓGYSZERGYÁR ZRT HU Sumamed forte 200 mg/5 ml por sziruphoz not available OGYI-T-5272/08 TEVA GYÓGYSZERGYÁR ZRT HU EMA/24970/2018 Page 13/30

14 Sumamed forte 200 mg/5 ml prašak za oralnu suspenziju Sumamed forte 200 mg/5 ml prašak za oralnu suspenziju Sumamed Forte 200 mg/5 ml pulbere pentru suspensie orală Sumamed forte 200 mg/5 ml pulveris iekškigi lietojamas suspensijas pagatavošanai Sumamed forte prášok na sirup National Number not available HR-H PLIVA HRVATSKA D.O.O. HR not available HR-H PLIVA HRVATSKA D.O.O. HR not available 8767/2016/ PLIVA LJUBLJANA D.O.O.; RO not available TEVA PHARMA B.V. LV not available 15/0352/92-C/S TEVA PHARMACEUTICALS SLOVAKIA S.R.O SK SUMAMED forte sirup prášek pro perorální suspenzi SUMAMED FORTE, 200 mg/5 ml suukaudse suspensiooni pulber SUMAMED forte, 200 mg/5 ml, proszek do sporządzania zawiesiny doustnej not available 15/352/92-B/C TEVA PHARMACEUTICALS CR, S.R.O. CZ not available TEVA PHARMA B.V. EE not available 7422 TEVA PHARMACEUTICALS PL POLSKA SP. Z O.O. EMA/24970/2018 Page 14/30

15 Sumamed prášok na sirup National Number not available 15/0352/92-C/S TEVA PHARMACEUTICALS SLOVAKIA S.R.O SK Sumamed S 500 mg filmom obložene tablete not available HR-H PLIVA HRVATSKA D.O.O. HR SUMAMED S 500 mg filmsko obložene tablete not available H/92/01472/004 PLIVA LJUBLJANA D.O.O.; SI Sumamed S 500 mg filmtabletta not available OGYI-T-5272/06 TEVA GYÓGYSZERGYÁR ZRT HU SUMAMED sirup prášek pro perorální suspenzi not available 15/352/92-A/C TEVA PHARMACEUTICALS CR, S.R.O. CZ SUMAMED STD potahované tablety not available 15/249/02-C TEVA PHARMACEUTICALS CR, S.R.O. CZ Sumamed tvrdé kapsuly not available 15/0226/90-C/S TEVA PHARMACEUTICALS SLOVAKIA S.R.O SK SUMAMED tvrdé tobolky not available 15/226/90-C TEVA PHARMACEUTICALS CR, S.R.O. CZ SUMAMED za otroke 20 mg/ml prašek za peroralno suspenzijo not available H/92/01472/005 PLIVA LJUBLJANA D.O.O.; SI EMA/24970/2018 Page 15/30

16 SUMAMED, 100 mg/5 ml suukaudse suspensiooni pulber SUMAMED, 100 mg/5 ml, proszek do sporządzania zawiesiny doustnej Sumamed, 125 mg, tabletki powlekane National Number not available TEVA PHARMA B.V. EE not available 7421 TEVA PHARMACEUTICALS POLSKA SP. Z O.O. not available 8462 TEVA PHARMACEUTICALS POLSKA SP. Z O.O. PL PL SUMAMED, 250 mg kõvakapslid not available TEVA PHARMA B.V. EE Sumamed, 250 mg, kapsułki twarde not available 7423 TEVA PHARMACEUTICALS POLSKA SP. Z O.O. PL SUMAMED, 500 mg õhukese polümeerikattega tabletid SUMAMED, 500 mg, proszek do sporządzania roztworu do infuzji Sumamed, 500 mg, tabletki powlekane not available TEVA PHARMA B.V. EE not available 9016 TEVA PHARMACEUTICALS PL POLSKA SP. Z O.O. not available 7424 TEVA PHARMACEUTICALS PL POLSKA SP. Z O.O. TROZOCINA 2 g granulato per sospensione orale a rilascio prolungato not available SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. IT EMA/24970/2018 Page 16/30

17 TROZOCINA 200 mg/5 ml polvere per sospensione orale TROZOCINA 200 mg/5 ml polvere per sospensione orale TROZOCINA 250 mg capsule rigide TROZOCINA 500 mg compresse rivestite con film TROZOCINA 500 mg polvere per soluzione per infusione TROZOCINA Avium 600 mg compresse rivestite con film Ultreon 600 mg Filmtabletten National Number not available SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. IT not available SIGMA-TAU INDUSTRIE IT FARMACEUTICHE RIUNITE S.P.A. not available SIGMA-TAU INDUSTRIE IT FARMACEUTICHE RIUNITE S.P.A. not available SIGMA-TAU INDUSTRIE IT FARMACEUTICHE RIUNITE S.P.A. not available SIGMA-TAU INDUSTRIE IT FARMACEUTICHE RIUNITE S.P.A. not available SIGMA-TAU INDUSTRIE IT FARMACEUTICHE RIUNITE S.P.A. not available PFIZER PHARMA PFE GMBH DE Zetamax, 2 g, granulat o PT/H/0146/ PFIZER EUROPE MA EEIG PL przedłużonym uwalnianiu do sporządzania zawiesiny doustnej ZITHROMAX not available PFIZER HELLAS, A.E. CY EMA/24970/2018 Page 17/30

18 Zithromax 2 g granulado de libertação prolongada para suspensão oral Zithromax 2 g granulado de libertação prolongada para suspensão oral Zithromax 200 mg in 5 ml suspension National Number PT/H/0146/ LABORATÓRIOS PFIZER, LDA. PT/H/0146/ LABORATÓRIOS PFIZER, LDA. not available MA505/03901 PFIZER HELLAS, A.E. MT PT PT Zithromax 200 mg in 5 ml suspension not available PL 00057/0336 PFIZER LIMITED UK Zithromax 200 mg/5 ml - Trockensaft ZITHROMAX 200 mg/5 ml κόνις για πόσιμο εναιώρημα ZITHROMAX 200 mg/5ml κόνις για πόσιμο εναιώρημα ZITHROMAX 250 mg CAPSULES not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT not available 41167/10/ PFIZER HELLAS, A.E. GR not available PFIZER HELLAS, A.E. CY not available MA505/03902 PFIZER HELLAS, A.E. MT ZITHROMAX 250 mg CAPSULES not available PL 00057/0335 PFIZER LIMITED UK EMA/24970/2018 Page 18/30

19 ZITHROMAX 250 mg filmdragerade tabletter azitromycin Zithromax 250 mg tabletti, kalvopäällysteinen ZITHROMAX 250 mg επικαλυμμένα με λεπτό υμένιο δισκία ZITHROMAX 250 mg καψάκια σκληρά National Number not available PFIZER OY FI not available PFIZER OY FI not available 44407/ PFIZER HELLAS, A.E. GR not available 44405/ PFIZER HELLAS, A.E. GR ZITHROMAX 250 mg, comprimé pelliculé not available PFIZER HOLDING FRANCE (S.C.A.) FR ZITHROMAX 250 mg, comprimé pelliculé not available PFIZER HOLDING FRANCE (S.C.A.) FR Zithromax 250, tabletten 250 mg not available RVG PFIZER B.V. NL ZITHROMAX 40 mg/ml ENFANTS, poudre pour suspension buvable ZITHROMAX 40 mg/ml ENFANTS, poudre pour suspension buvable not available PFIZER HOLDING FRANCE FR not available PFIZER HOLDING FRANCE FR EMA/24970/2018 Page 19/30

20 ZITHROMAX 40 mg/ml ENFANTS, poudre pour suspension buvable ZITHROMAX 40 mg/ml ENFANTS, poudre pour suspension buvable Zithromax 40 mg/ml jauhe oraalisuspensiota varten Zithromax 40 mg/ml pó para suspensão oral National Number not available PFIZER HOLDING FRANCE FR not available PFIZER HOLDING FRANCE FR not available PFIZER OY FI not available LABORATÓRIOS PFIZER, LDA. PT Zithromax 40 mg/ml pó para suspensão oral not available LABORATÓRIOS PFIZER, LDA. PT Zithromax 40 mg/ml pó para suspensão oral not available LABORATÓRIOS PFIZER, LDA. PT Zithromax 40 mg/ml pó para suspensão oral not available LABORATÓRIOS PFIZER, LDA. PT ZITHROMAX 40 mg/ml pulver till oral suspension azitromycin Zithromax 500 mg - Filmtabletten not available PFIZER OY FI not available PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. EMA/24970/2018 Page 20/30

21 Zithromax 500 mg comprimido revestido por película Zithromax 500 mg comprimido revestido por película ZITHROMAX 500 mg filmdragerade tabletter azitromycin Zithromax 500 mg tabletti, kalvopäällysteinen ZITHROMAX 500 mg επικαλυμμένα με λεπτό υμένιο δισκία Zithromax 500, tabletten 500 mg National Number not available LABORATÓRIOS PFIZER, LDA. not available LABORATÓRIOS PFIZER, LDA. not available PFIZER OY FI not available PFIZER OY FI not available 44409/ PFIZER HELLAS, A.E. GR not available RVG PFIZER B.V. NL PT PT Zithromax Capsules 250 mg not available PA 19/47/1 PFIZER LIMITED IE Zithromax i.v. 500 mg Pulver zur Herstellung einer Infusionslösung Zithromax IV 500 mg infuusiokuiva-aine, liuosta varten not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT not available PFIZER OY FI EMA/24970/2018 Page 21/30

22 Zithromax IV 500 mg pó para solução para perfusão Zithromax IV 500 mg pó para solução para perfusão ZITHROMAX IV 500 mg pulver till infusionsvätska, lösning azitromycin ZITHROMAX MONODOSE 250 mg, comprimé pelliculé ZITHROMAX MONODOSE 250 mg, comprimé pelliculé Zithromax Powder for Oral Suspension 200 mg/5 ml ZITHROMAX, 500mg/φιαλίδιο, κόνις για διάλυμα προς έγχυση Zithromax, suspensie (poeder voor) 200 mg/5 ml Zithromax 250 mg Filmtabletten National Number not available LABORATÓRIOS PFIZER, LDA. not available LABORATÓRIOS PFIZER, LDA. not available PFIZER OY FI not available PFIZER HOLDING FRANCE (S.C.A.) not available PFIZER HOLDING FRANCE (S.C.A.) not available PA 19/47/2 PFIZER LIMITED IE not available 44411/ PFIZER HELLAS, A.E. GR not available RVG PFIZER B.V. NL not available PFIZER PHARMA PFE GMBH DE PT PT FR FR EMA/24970/2018 Page 22/30

23 Zithromax 500 mg Filmtabletten National Number not available PFIZER PHARMA PFE GMBH DE Zithromax i.v. 500 mg Pulver zur Herstellung einer Infusionslösung Zithromax Trockensaft 200 mg/5 ml, Pulver zur Herstellung einer Suspension zum Einnehmen Zitinn 250 mg filmtabletta not available PFIZER PHARMA PFE GMBH DE not available PFIZER PHARMA PFE GMBH DE NL/H/2400/001 OGYI-T-22373/01-04 ACTAVIS GROUP PTC EHF. HU Zitrocin 100 mg/5 ml por sziruphoz not available OGYI-T-9027/03 TEVA MAGYARORSZÁG ZRT HU Zitrocin 250 mg kemény kapszula not available OGYI-T-9027/04 TEVA GYÓGYSZERGYÁR ZRT HU Zitrocin 500 mg filmtabletta not available OGYI-T-9027/05 TEVA GYÓGYSZERGYÁR ZRT HU Zitrocin forte 200 mg/5 ml por sziruphoz not available OGYI-T-9027/02 TEVA GYÓGYSZERGYÁR ZRT HU Zitrocin forte 200 mg/5 ml por sziruphoz not available OGYI-T-9027/07 TEVA GYÓGYSZERGYÁR ZRT HU EMA/24970/2018 Page 23/30

24 Zitrocin S 500 mg filmtabletta National Number not available OGYI-T-9027/06 TEVA GYÓGYSZERGYÁR ZRT HU ZITROMAX 100 mg polvere per sospensione orale ZITROMAX 1000 mg polvo para suspensión oral en sobre ZITROMAX 150 mg polvere per sospensione orale ZITROMAX 2 g granulato per sospensione orale a rilascio prolungato ZITROMAX 200 mg polvere per sospensione orale ZITROMAX 200 mg/5 ml Poeder voor orale suspensie ZITROMAX 200 mg/5 ml polvere per sospensione orale ZITROMAX 200 mg/5 ml polvere per sospensione orale not available PFIZER ITALIA S.R.L. IT not available PFIZER, S.L. ES not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available BE PFIZER S.A. (BELGIUM) BE not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT EMA/24970/2018 Page 24/30

25 ZITROMAX 200 mg/5 ml polvere per sospensione orale ZITROMAX 200 mg/5 ml polvere per sospensione orale ZITROMAX 200 mg/5 ml polvo para suspensión oral en frasco ZITROMAX 200 mg/5 ml Poudre pour suspension buvable Zitromax 200 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen Zitromax 200 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen Azithromycin ZITROMAX 200 mg/5ml Poudre pour suspension buvable ZITROMAX 250 mg cápsulas duras National Number not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available PFIZER, S.L. ES not available PFIZER S.A. (BELGIUM) LU not available BE PFIZER S.A. (BELGIUM) BE not available PFIZER S.A. (BELGIUM) LU not available BE PFIZER S.A. (BELGIUM) BE not available PFIZER, S.L. ES EMA/24970/2018 Page 25/30

26 ZITROMAX 250 mg capsule rigide National Number not available PFIZER ITALIA S.R.L. IT ZITROMAX 250 mg Comprimés pelliculés not available BE PFIZER S.A. (BELGIUM) BE ZITROMAX 250 mg Comprimés pelliculés not available PFIZER S.A. (BELGIUM) LU ZITROMAX 250 mg Filmomhulde tabletten not available BE PFIZER S.A. (BELGIUM) BE Zitromax 250 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Zitromax 250 mg Filmtabletten Azithromycin Zitromax 250 mg filmuhúðaðar töflur not available PFIZER S.A. (BELGIUM) LU not available PFIZER APS IS ZITROMAX 250 mg polvo para suspensión oral en sobre ZITROMAX 300 mg polvere per sospensione orale not available PFIZER, S.L. ES not available PFIZER ITALIA S.R.L. IT EMA/24970/2018 Page 26/30

27 Zitromax 40 mg/ml mixtúruduft, dreifa National Number not available PFIZER APS IS ZITROMAX 400 mg polvere per sospensione orale ZITROMAX 500 mg compresse rivestite con film ZITROMAX 500 mg Comprimés pelliculés not available PFIZER ITALIA S.R.L. IT not available PFIZER ITALIA S.R.L. IT not available BE PFIZER S.A. (BELGIUM) BE ZITROMAX 500 mg Comprimés pelliculés not available PFIZER S.A. (BELGIUM) LU ZITROMAX 500 mg comprimidos recubiertos con película ZITROMAX 500 mg Filmomhulde tabletten not available PFIZER, S.L. ES not available BE PFIZER S.A. (BELGIUM) BE Zitromax 500 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Zitromax 500 mg Filmtabletten Azithromycin not available PFIZER S.A. (BELGIUM) LU EMA/24970/2018 Page 27/30

28 Zitromax 500 mg filmuhúðaðar töflur National Number not available PFIZER APS IS Zitromax 500 mg innrennslisstofn, lausn not available IS/1/02/106/01 PFIZER APS IS ZITROMAX 500 mg polvere per soluzione per infusione ZITROMAX 500 mg polvo para solución para perfusión ZITROMAX 500 mg polvo para suspensión oral en sobre ZITROMAX 600 mg Comprimés pelliculés not available PFIZER ITALIA S.R.L. IT not available PFIZER, S.L. ES not available PFIZER, S.L. ES not available BE PFIZER S.A. (BELGIUM) BE ZITROMAX 600 mg Comprimés pelliculés not available PFIZER S.A. (BELGIUM) LU ZITROMAX 600 mg Filmomhulde tabletten not available BE PFIZER S.A. (BELGIUM) BE Zitromax 600 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE EMA/24970/2018 Page 28/30

29 Zitromax 600 mg Filmtabletten Azithromycin ZITROMAX Avium 600 mg compresse rivestite con film Zitromax UNO forðakyrni fyrir mixtúru, dreifu National Number not available PFIZER S.A. (BELGIUM) LU not available PFIZER ITALIA S.R.L. IT not available IS/1/05/134/01 PFIZER APS IS Zitromax UNO, depotgranulat til oral suspension Zitromax, filmovertrukne tabletter not available PFIZER APS DK not available PFIZER APS DK Zitromax, filmovertrukne tabletter not available PFIZER APS DK Zitromax, filmovertrukne tabletter not available PFIZER APS DK Zitromax, Pulver til koncentrat til infusionsvæske, opløsning Zitromax, pulver til oral suspension not available PFIZER APS DK not available PFIZER APS DK EMA/24970/2018 Page 29/30

30 Zmax 2 g retard granulátum belsőleges szuszpenzióhoz Азибиот 20 mg/ml прах за перорална суспензия National Number PT/H/0146/001 OGYI-T-20770/01 PFIZER KFT. HU SK/H/0148/ KRKA, D.D., NOVO MESTO BG Зимакс 2 g гранули с удължено освобождаване за перорална суспензия Сумамед 250 mg капсули, твърди not available PFIZER EUROPE MA EEIG BG not available ECOPHARM GROUP BG СУМАМЕД 500 mg прах за инфузионен разтвор not available TEVA PHARMACEUTICALS BULGARIA EOOD BG Сумамед 500 mg филмирани таблетки not available ECOPHARM GROUP BG Сумамед сироп 100mg/5ml прах за перорална суспензия Сумамед форте сироп 200mg/5ml прах за перорална суспензия not available ECOPHARM GROUP BG not available ECOPHARM GROUP BG EMA/24970/2018 Page 30/30