List of nationally authorised medicinal products
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1 19 July 2017 EMA/270645/2015 Human Medicines Evaluation Division Active substance: lenograstim 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 GRANOCYTE FR/H/0044/ SANOFI-AVENTIS DENMARK DK A/S GRANOCYTE FR/H/0044/ SANOFI-AVENTIS DENMARK DK A/S GRANOCYTE FR/H/0044/ / SANOFI-AVENTIS AEBE GR GRANOCYTE FR/H/0044/ / SANOFI-AVENTIS AEBE GR GRANOCYTE FR/H/0044/ / SANOFI-AVENTIS AEBE GR GRANOCYTE FR/H/0044/ / SANOFI-AVENTIS AEBE GR GRANOCYTE FR/H/0044/ / SANOFI-AVENTIS AEBE GR GRANOCYTE FR/H/0044/ / SANOFI-AVENTIS AEBE GR GRANOCYTE FR/H/0044/ / SANOFI-AVENTIS AEBE GR GRANOCYTE 13 milhões de perfusão FR/H/0044/ SANOFI - PRODUTOS GRANOCYTE 13 milhões de perfusão GRANOCYTE 13 milhões de perfusão GRANOCYTE 13 milhões de perfusão GRANOCYTE 13 milioni GRANOCYTE 13 milioni FR/H/0044/ SANOFI - PRODUTOS FR/H/0044/ SANOFI - PRODUTOS FR/H/0044/ SANOFI - PRODUTOS FR/H/0044/ ITALFARMACO S.P.A IT FR/H/0044/ ITALFARMACO S.P.A IT EMA/560693/2017 Page 2/10
3 GRANOCYTE 13 milioni GRANOCYTE 13 milioni GRANOCYTE 13 MILJ. IU/ML, INJEKTIO/INFUUSIOKUIVA- AINE JA LIUOTIN, LIUOSTA VARTEN GRANOCYTE 13 MILJ. IU/ML, INJEKTIO/INFUUSIOKUIVA- AINE JA LIUOTIN, LIUOSTA VARTEN GRANOCYTE 13 MILJ. IU/ML, INJEKTIO/INFUUSIOKUIVA- AINE JA LIUOTIN, LIUOSTA VARTEN GRANOCYTE 13 MILJ. IU/ML, INJEKTIO/INFUUSIOKUIVA- AINE JA LIUOTIN, LIUOSTA VARTEN Granocyte 13 miljoen IE/ml, poeder en oplosmiddel voor oplossing voor injectie/infusie in een voorgevulde spuit GRANOCYTE 13 million injection/infusion, in a prefilled syringe FR/H/0044/ ITALFARMACO S.P.A IT FR/H/0044/ ITALFARMACO S.P.A IT FR/H/0044/ SANOFI OY FI FR/H/0044/ SANOFI OY FI FR/H/0044/ SANOFI OY FI FR/H/0044/ SANOFI OY FI FR/H/0044/001 BE CHUGAI PHARMA FRANCE BE FR/H/0044/001 PA 0950/002/002 CHUGAI PHARMA UK LTD IE EMA/560693/2017 Page 3/10
4 GRANOCYTE 13 million FR/H/0044/001 PL 12185/0002 CHUGAI PHARMA UK LTD UK injection/infusion in a prefilled syringe GRANOCYTE 13 million FR/H/0044/001 PL 12185/0002 CHUGAI PHARMA UK LTD UK injection/infusion Granocyte 13 Millionen FR/H/0044/ BE CHUGAI PHARMA FRANCE BE Herstellung einer Injektionslösung/Infusionslö sung in einer Fertigspritze Granocyte 13 millions UI/ml, FR/H/0044/001 BE CHUGAI PHARMA FRANCE BE poudre et solvant pour solution injectable/pour perfusion dans une seringue GRANOCYTE 13 millions FR/H/0044/ / ( CHUGAI PHARMA FRANCE LU UI/mL, poudre et solvant pour solution injectable/pour perfusion dans une seringue ) GRANOCYTE 13 millones de FR/H/0044/ ITALFARMACO S.A. ES UI polvo y disolvente para solucion inyectable o perfusion GRANOCYTE 34 not available SANOFI-AVENTIS CYPRUS CY LTD GRANOCYTE 34 not available SANOFI-AVENTIS CYPRUS CY LTD GRANOCYTE 34 not available SANOFI-AVENTIS CYPRUS LTD CY EMA/560693/2017 Page 4/10
5 GRANOCYTE 34 (33,6 milijono TV/ml) milteliai ir tirpiklis injekciniam ar infuziniam tirpalui GRANOCYTE 34 (33,6 milijono TV/ml) milteliai ir tirpiklis injekciniam ar infuziniam tirpalui GRANOCYTE 34 (33,6 milijono TV/ml) milteliai ir tirpiklis injekciniam ar infuziniam tirpalui GRANOCYTE 34 (33,6 milijono TV/ml) milteliai ir tirpiklis injekciniam ar infuziniam tirpalui GRANOCYTE 34 milhões de perfusão. GRANOCYTE 34 milhões de perfusão. GRANOCYTE 34 milhões de perfusão. GRANOCYTE 34 milhões de perfusão. GRANOCYTE 34 milioni not available LT/1/99/1427/002 UAB SANOFI-AVENTIS LIETUVA not available LT/1/99/1427/003 UAB SANOFI-AVENTIS LIETUVA not available LT/1/99/1427/004 UAB SANOFI-AVENTIS LIETUVA not available LT/1/99/1427/001 UAB SANOFI-AVENTIS LIETUVA FR/H/0044/ SANOFI - PRODUTOS FR/H/0044/ SANOFI - PRODUTOS FR/H/0044/ SANOFI - PRODUTOS FR/H/0044/ SANOFI - PRODUTOS FR/H/0044/ ITALFARMACO S.P.A IT LT LT LT LT EMA/560693/2017 Page 5/10
6 GRANOCYTE 34 milioni GRANOCYTE 34 milioni GRANOCYTE 34 milioni GRANOCYTE 34 miljoen IE/ml, poeder en oplosmiddel voor oplossing voor injectie/infusie in een voorgevulde spuit GRANOCYTE 34 million injection/infusion, in a prefilled syringe GRANOCYTE 34 million injection/infusion in a prefilled syringe GRANOCYTE 34 million injection/infusion FR/H/0044/ ITALFARMACO S.P.A IT FR/H/0044/ ITALFARMACO S.P.A IT FR/H/0044/ ITALFARMACO S.P.A IT FR/H/0044/002 BE CHUGAI PHARMA FRANCE BE FR/H/0044/002 PA 0950/002/001 CHUGAI PHARMA UK LTD IE FR/H/0044/002 PL 12185/0002 CHUGAI PHARMA UK LTD UK FR/H/0044/002 PL 12185/0002 CHUGAI PHARMA UK LTD UK EMA/560693/2017 Page 6/10
7 GRANOCYTE 34 Millionen Herstellung einer Injektionslösung/Infusionslö sung in einer Fertigspritze Granocyte 34 millions UI/ml, poudre et solvant pour solution injectable/pour perfusion dans une seringue Granocyte 34 millions UI/ml, poudre et solvant pour solution injectable/pour perfusion dans une seringue GRANOCYTE 34 millones de UI polvo y disolvente para solucion inyectable o perfusion Granocyte, 34 miljoner IE/ml, pulver och vätska till injektions- eller infusionsvätska, lösning. Granocyte, 34 miljoner IE/ml, pulver och vätska till injektions- eller infusionsvätska, lösning. Granocyte, 34 miljoner IE/ml, pulver och vätska till injektions- eller infusionsvätska, lösning. Granocyte, 34 miljoner IE/ml, pulver och vätska till injektions- eller infusionsvätska, lösning. FR/H/0044/002 BE CHUGAI PHARMA FRANCE BE FR/H/0044/002 BE CHUGAI PHARMA FRANCE BE FR/H/0044/ / ( ) CHUGAI PHARMA FRANCE FR/H/0044/ ITALFARMACO S.A. ES FR/H/0044/ SANOFI AB SE FR/H/0044/ SANOFI AB SE FR/H/0044/ SANOFI AB SE FR/H/0044/ SANOFI AB SE LU EMA/560693/2017 Page 7/10
8 Granocyte, 34 miljoner IE/ml, pulver och vätska till injektions- eller infusionsvätska, lösning. GRANOCYTE 13 Millionen Herstellung einer Injektionsoder Infusionslösung in einer vorgefüllten Spritze GRANOCYTE 13 Millionen Herstellung einer Injektionsoder Infusionslösung GRANOCYTE 13 Millions pour solution injectable/perfusion en seringue GRANOCYTE 13 Millions pour solution injectable/perfusion GRANOCYTE 13 Millions pour solution injectable/perfusion GRANOCYTE 13 Millions pour solution injectable/perfusion en seringue FR/H/0044/ SANOFI AB SE FR/H/0044/ CHUGAI PHARMA EUROPE LTD ZWEIGNIEDERLASSUNG DEUTSCHLAND FR/H/0044/ CHUGAI PHARMA EUROPE LTD ZWEIGNIEDERLASSUNG DEUTSCHLAND FR/H/0044/ CHUGAI PHARMA FRANCE FR FR/H/0044/ CHUGAI PHARMA FRANCE FR FR/H/0044/ CHUGAI PHARMA FRANCE FR FR/H/0044/ CHUGAI PHARMA FRANCE FR DE DE EMA/560693/2017 Page 8/10
9 GRANOCYTE 34 Millionen Herstellung einer Injektionsoder Infusionslösung in einer vorgefüllten Spritze GRANOCYTE 34 Millionen Herstellung einer Injektionsoder Infusionslösung GRANOCYTE 34 Millions pour solution injectable / perfusion GRANOCYTE 34 Millions pour solution injectable / perfusion en seringue GRANOCYTE 34 Millions pour solution injectable / perfusion GRANOCYTE 34 Millions pour solution injectable / perfusion en seringue MYELOSTIM 13 milioni MYELOSTIM 13 milioni FR/H/0044/ CHUGAI PHARMA EUROPE LTD ZWEIGNIEDERLASSUNG DEUTSCHLAND FR/H/0044/ CHUGAI PHARMA EUROPE LTD ZWEIGNIEDERLASSUNG DEUTSCHLAND FR/H/0044/ CHUGAI PHARMA FRANCE FR FR/H/0044/ CHUGAI PHARMA FRANCE FR FR/H/0044/ CHUGAI PHARMA FRANCE FR FR/H/0044/ CHUGAI PHARMA FRANCE FR not available ITALFARMACO S.P.A IT not available ITALFARMACO S.P.A IT DE DE EMA/560693/2017 Page 9/10
10 MYELOSTIM 13 milioni MYELOSTIM 13 milioni MYELOSTIM 34 milioni MYELOSTIM 34 milioni MYELOSTIM 34 milioni MYELOSTIM 34 milioni not available ITALFARMACO S.P.A IT not available ITALFARMACO S.P.A IT not available ITALFARMACO S.P.A IT not available ITALFARMACO S.P.A IT not available ITALFARMACO S.P.A IT not available ITALFARMACO S.P.A IT EMA/560693/2017 Page 10/10
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