List of nationally authorised medicinal products

Transcription

1 8 March 2018 EMA/182904/2018 Human Medicines Evaluation Division Active substance(s): fluticasone propionate / formoterol fumarate dihydrate 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 National Number Abriff 125 microgrammi/5 Abriff 125 microgrammi/5 Abriff 125 microgramos/5 microgramos inhalación Abriff 250 microgrammi/10 Abriff 250 microgrammi/10 Abriff 250 microgramos/10 microgramos inhalación, /H/4379/ /M MUNDIPHARMA /H/4379/ MUNDIPHARMA /H/4379/ MUNDIPHARMA /H/4379/ /M MUNDIPHARMA /H/4379/ MUNDIPHARMA /H/4379/ MUNDIPHARMA EMA/182904/2018 Page 2/17

3 National Number Abriff 50 microgrammi/5 Abriff 50 microgrammi/5 Abriff 50 microgramos/5 microgramos inhalación, Abriff 125 microgram/5 microgram per actuation Abriff 250 microgram/10 micro gram per actuation Abriff 50 microgram/5 microgr am per actuation AFFERA 125 /H/4379/ /M MUNDIPHARMA /H/4379/ MUNDIPHARMA /H/4379/ MUNDIPHARMA /H/4379/002 PL 16950/0189 NAPP PHARMACEUTICALS /H/4379/003 PL 16950/0190 NAPP PHARMACEUTICALS /H/4379/001 PL 16950/0188 NAPP PHARMACEUTICALS /H/4378/ MUNDIPHARMA FR EMA/182904/2018 Page 3/17

4 National Number Affera 125 microgrammi/5 Affera 125 microgramos/5 microgramos inhalación, AFFERA 250 microgrammes/10 Affera 250 microgrammi/10 Affera 250 microgramos/10 microgramos inhalación, AFFERA 50 /H/4378/ /M MUNDIPHARMA /H/4378/ MUNDIPHARMA /H/4378/ MUNDIPHARMA FR /H/4378/ /M MUNDIPHARMA /H/4378/ MUNDIPHARMA /H/4378/ MUNDIPHARMA FR EMA/182904/2018 Page 4/17

5 National Number Affera 50 microgrammi/5 Affera 50 microgramos/5 microgramos inhalación, affera 125 Mikrogramm/5 Affera 125 microgram/5 microg ram per actuation affera 250 Mikrogramm/10 Affera 250 microgram/10 micro gram per actuation /H/4378/ /M MUNDIPHARMA /H/4378/ MUNDIPHARMA /H/4378/ MUNDIPHARMA GMBH DE /H/4378/002 PL 16950/0186 NAPP PHARMACEUTICALS /H/4378/ MUNDIPHARMA GMBH DE /H/4378/003 PL 16950/0187 NAPP PHARMACEUTICALS affera 50 /H/4378/ MUNDIPHARMA GMBH DE EMA/182904/2018 Page 5/17

6 National Number Mikrogramm/5 Affera 50 microgram/5 microgr am per actuation 125 mcg/5 mcg, 125 microgram I 5 microgram, aerosol, suspensie 125 microgram/ 5 microgram I dosis aerosol, suspensie 125 microgram/5 microgram per metered dose 125 micrograme /5 micrograme suspensie de inhalat presurizată 125 microgrammes, /H/4378/001 PL 16950/0185 NAPP PHARMACEUTICALS /H/2872/ /DC MUNDIPHARMA COMM VA LU /H/2872/002 BE MUNDIPHARMA COMM VA BE /H/2872/001 RVG MUNDIPHARMA PHARMACEUTICALS BV /H/2872/002 PA 1688/13/2 MUNDIPHARMA PHARMACEUTICALS LIMED /H/2872/ /2013/01 MUNDIPHARMA G.M.B.H RO /H/2872/002 BE MUNDIPHARMA COMM VA BE NL IE EMA/182904/2018 Page 6/17

7 National Number FLUTIFORM microgramos/5 microgramos/inhalación, 125 mikrogram/ 5 mikrogram per dose, inhalasjonsaerosol, suspensjon 125 mikrogram/5 mikrogram per puff, inhalationsspray, 125 Mikrogramm/5 125 mikrogramov/5 mikrogramov 125 mikrogramů/5 mikrogramů v jedné /H/2872/ MUNDIPHARMA FR /H/2872/ MUNDIPHARMA /H/2872/ MUNDIPHARMA AS. NO /H/2872/ MUNDIPHARMA AB SE /H/2872/ MUNDIPHARMA GELLSCHAFT M.B.H. /H/2872/002 14/0357/12-S MUNDIPHARMA G.M.B.H SK /H/2872/002 14/554/12-C MUNDIPHARMA G.M.B.H CZ AT EMA/182904/2018 Page 7/17

8 National Number dávce, suspenze k inhalaci v tlakovém obalu 125 microgramas/5 micr ogramas suspensão pressurizada para inalação 125 mikrog/5 mikrog/an nos Inhalaatiosumute, suspensio 125 míkrógrömm/5 míkr ógrömm í úðaskammti innúðalyf, dreifa 125 μικρογραμμάρια/5 μικρογραμμάρια ανά ψεκασμό, εναιώρημα για εισπνοή υπό πίεση 250 mcg/10 mcg,. 250 microgram / 10 microgram I dosis aerosol, suspensie 250 microgram I 10 microgram, aerosol, suspensie 250 microgram/10 microgram per metered dose pressurised inhalation, /H/2872/ MUNDIPHARMA PHARMACEUTICALS /H/2872/ MUNDIPHARMA OY FI /H/2872/002 IS/1/12/096/02 NORPHARMA A/S IS /H/2872/ MUNDIPHARMA PHARMACEUTICALS /H/2872/ /DC MUNDIPHARMA COMM VA LU /H/2872/003 RVG MUNDIPHARMA PHARMACEUTICALS BV /H/2872/003 BE MUNDIPHARMA COMM VA BE /H/2872/003 PA 1688/13/3 MUNDIPHARMA PHARMACEUTICALS LIMED PT CY NL IE EMA/182904/2018 Page 8/17

9 National Number 250 micrograme/10 micrograme suspensie de inhalat presurizata 250 microgrammes/10 microgrammes, FLUTIFORM 250 microgrammes/ microgramos/10 microgramos/inhalación, 250 mikrogram/ 10 mikrogram per dose, inhalasjonsaerosol, suspensjon 250 mikrogram/10 mikrogram 250 mikrogram/10 mikrogram per puff, inhalationsspray, /H/2872/ /2013/01 MUNDIPHARMA G.M.B.H RO /H/2872/003 BE MUNDIPHARMA COMM VA BE /H/2872/ MUNDIPHARMA FR /H/2872/ MUNDIPHARMA /H/2872/ MUNDIPHARMA AS. NO /H/2872/003 14/0358/12-S MUNDIPHARMA G.M.B.H SK /H/2872/ MUNDIPHARMA AB SE EMA/182904/2018 Page 9/17

10 National Number 250 Mikrogramm/ mikrogramů/10 mikrogramů v jedné dávce, suspenze k inhalaci v tlakovém obalu 250 microgramas/10 mic rogramas suspensão pressurizada para inalação 250 mikrog/10 mikrog/a nnos Inhalaatiosumute, suspensio 250 míkrógrömm/10 mík rógrömm í úðaskammti innúðalyf, dreifa 250 μικρογραμμάρια/10 μικρογραμμάρια ανά ψεκασμό, εναιώρημα για εισπνοή υπό πίεση 50 mcg/5 mcg, 50 microgram / 5 microgram, aërosol, /H/2872/ MUNDIPHARMA GELLSCHAFT M.B.H. /H/2872/003 14/555/12-C MUNDIPHARMA G.M.B.H CZ /H/2872/ MUNDIPHARMA PHARMACEUTICALS /H/2872/ MUNDIPHARMA OY FI /H/2872/003 IS/1/12/096/03 NORPHARMA A/S IS /H/2872/ MUNDIPHARMA PHARMACEUTICALS /H/2872/ MUNDIPHARMA COMM VA LU /H/2872/001 BE MUNDIPHARMA COMM VA BE AT PT CY EMA/182904/2018 Page 10/17

11 National Number suspensie 50 microgram I 5 microgram I dosis aerosol, suspensie 50 microgram/5 microgram per metered dose 50 micrograme /5 micrograme suspensie de inhalat presurizată 50 microgrammes, FLUTIFORM microgramos/5 microgramos/inhalación, 50 mikrogram/ 5 mikrogram per dose, inhalasjonsaerosol, suspensjon /H/2872/001 RVG MUNDIPHARMA PHARMACEUTICALS BV /H/2872/001 PA 1688/13/1 MUNDIPHARMA PHARMACEUTICALS LIMED /H/2872/ /2013/01 MUNDIPHARMA G.M.B.H RO /H/2872/001 BE MUNDIPHARMA COMM VA BE /H/2872/ MUNDIPHARMA FR /H/2872/001/E/ MUNDIPHARMA /H/2872/ MUNDIPHARMA AS. NO 50 /H/2872/ MUNDIPHARMA AB SE NL IE EMA/182904/2018 Page 11/17

12 National Number mikrogram/5 mikrogram per puff, inhalationsspray, 50 Mikrogramm/5 50 mikrogramov/5 mikrogramov 50 mikrogramů/5 mikrogramů v jedné dávce, suspenze k inhalaci v tlakovém obalu 50 μικρογραμμάρια/5 μικρογραμμάρια ανά ψεκασμό, εναιώρημα για εισπνοή υπό πίεση. 50 microgramas/5 micro gramas suspensão pressurizada para inalação 50 mikrog/5 mikrog/ann os Inhalaatiosumute, suspensio 50 míkrógrömm/5 míkró grömm í úðaskammti /H/2872/ MUNDIPHARMA GELLSCHAFT M.B.H. /H/2872/001 14/0356/12-S MUNDIPHARMA G.M.B.H SK /H/2872/001 14/553/12-C MUNDIPHARMA G.M.B.H CZ /H/2872/ MUNDIPHARMA PHARMACEUTICALS /H/2872/ MUNDIPHARMA PHARMACEUTICALS /H/2872/ MUNDIPHARMA OY FI /H/2872/001 IS/1/12/096/01 NORPHARMA A/S IS AT CY PT EMA/182904/2018 Page 12/17

13 National Number innúðalyf, dreifa, (125 mikrogramów + 5 mikrogramów)/dawke inhalacyjna, aerozol inhalacyjny, zawiesina, (250 mikrogramów + 10 mikrogramów)/dawkę inhalacyjną, aerozol inhalacyjny, zawiesina, (50 mikrogramów + 5 mikrogramów)/dawke inhalacyjna, aerozol inhalacyjny, zawiesina, inhalationsspray,, inhalationsspray,, inhalationsspray, 125 microgram/5 microgram per actuation pressurised inhalation, flutiform 125 Mikrogramm/5 /H/2872/ NORPHARMA A/S PL /H/2872/ NORPHARMA A/S PL /H/2872/ NORPHARMA A/S PL /H/2872/ NORPHARMA A/S DK /H/2872/ NORPHARMA A/S DK /H/2872/ NORPHARMA A/S DK /H/2872/002 PL 16950/0168 NAPP PHARMACEUTICALS /H/2872/ MUNDIPHARMA GMBH DE EMA/182904/2018 Page 13/17

14 National Number 250 microgram/10 microgram per actuation. flutiform 250 Mikrogramm/10 50 microgram/5 microgram per actuation pressurised inhalation, flutiform 50 Mikrogramm/5 o 125 microgrammi/5 o 125 microgrammi/5 o 250 microgrammi/10 /H/2872/003 PL 16950/0190 NAPP PHARMACEUTICALS /H/2872/ MUNDIPHARMA GMBH DE /H/2872/001 PL 16950/0167 NAPP PHARMACEUTICALS /H/2872/ MUNDIPHARMA GMBH DE /H/2872/ MUNDIPHARMA /H/2872/ MUNDIPHARMA /H/2872/ MUNDIPHARMA EMA/182904/2018 Page 14/17

15 National Number o 250 microgrammi/10 o 50 microgrammi/5 o 50 microgrammi/5 Iffeza 125 microgram / 5 microgram per dosis, aerosol, suspensie Iffeza 125 microgrammes, IFFEZA 125 /H/2872/ MUNDIPHARMA /H/2872/ MUNDIPHARMA /H/2872/ MUNDIPHARMA /H/4015/002 BE MUNDIPHARMA COMM VA BE /H/4015/002 BE MUNDIPHARMA COMM VA BE /H/4015/ MUNDIPHARMA FR EMA/182904/2018 Page 15/17

16 National Number Iffeza 250 microgram / 10 microgram per dosis, aerosol, suspensie Iffeza 250 microgrammes/10 microgrammes, IFFEZA 250 microgrammes/10 Iffeza 50 microgram / 5 microgram per dosis, aerosol, suspensie Iffeza 50 microgrammes, IFFEZA 50 ФЛУТИФОРМ 125 микрограма/5 микрограма на /H/4015/003 BE MUNDIPHARMA COMM VA BE /H/4015/003 BE MUNDIPHARMA COMM VA BE /H/4015/ MUNDIPHARMA FR /H/4015/001 BE MUNDIPHARMA COMM VA BE /H/4015/001 BE MUNDIPHARMA COMM VA BE /H/4015/ MUNDIPHARMA FR /H/2872/002/DC MUNDIPHARMA G.M.B.H BG EMA/182904/2018 Page 16/17

17 National Number впръскване, суспензия под налягане за инхалация ФЛУТИФОРМ 250 микрограма/10 микрограма на впръскване, суспензия под налягане за инхалация ФЛУТИФОРМ 50 микрограма/5 микрограма на впръскване, суспензия под налягане за инхалация /H/2872/003/DC MUNDIPHARMA G.M.B.H BG /H/2872/001/DC MUNDIPHARMA G.M.B.H BG EMA/182904/2018 Page 17/17