1 September 2017 EMA/579275/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): yellow fever vaccine (live)

Procedure No.: PSUSA/00003135/201612

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

STAMARIL Injektiokuiva-aine ja liuotin, suspensiota varten, esitäytetty ruisku Keltakuumerokote (elävä) STAMARIL milteliai ir tirpiklis injekcinei suspensijai Gyvoji vakcina nuo geltonosios karštines STAMARIL milteliai ir tirpiklis injekcinei suspensijai Gyvoji vakcina nuo geltonosios karštines STAMARIL milteliai ir tirpiklis injekcinei suspensijai Gyvoji vakcina nuo geltonosios karštines STAMARIL milteliai ir tirpiklis injekcinei suspensijai, Gyvoji vakcina nuo geltonosios karštines STAMARIL Poeder en oplosmiddel voor suspensie voor injectie in voorgevulde spuit. Gelekoortsvaccin (levend) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz List of nationally authorised medicinal products EMA/579275/2017

MRP/DCP Authorisation number

National Authorisation Number

DE/H/0476/001

11678

DE/H/0476/001

LT/1/08/1190/002

DE/H/0476/001

LT/1/08/1190/003

DE/H/0476/001

LT/1/08/1190/004

DE/H/0476/001

LT/1/08/1190/001

DE/H/0476/001

RVG 17615

DE/H/0476/001

OGYI-T-20076/002

DE/H/0476/001

OGYI-T-20076/003

DE/H/0476/001

OGYI-T-20076/004

DE/H/0476/001

OGYI-T-20076/005

DE/H/0476/001

OGYI-T-20076/006

DE/H/0476/001

OGYI-T-20076/007

DE/H/0476/001

OGYI-T-20076/008

DE/H/0476/001

OGYI-T-20076/009

DE/H/0476/001 DE/H/0476/001

OGYI-T-20076/010 OGYI-T-20076/011

MAH of product in the member state

SANOFI PASTEUR EUROPE SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR EUROPE SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR

Member State where product is authorised

FI LT LT LT LT NL HU HU HU HU HU HU HU HU HU HU Page 2/5

Product Name (in authorisation country)

sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz sárgaláz vakcina (élo) STAMARIL por és oldószer szuszpenziós injekcióhoz, sárgaláz vakcina (élő) STAMARIL Prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki, Cjepivo protiv žute groznice, živo STAMARIL Prášek pro prípravu injekcní suspenze s rozpouštedlem v predplnené injekcní stríkacce, Vakcína proti žluté zimnici (živá). STAMARIL Prášok a rozpúštadlo na injekcnú suspenziu v naplnenej injekcnej striekacke, Ockovacia látka proti žltej zimnici (živá). STAMARIL Proszek i rozpuszczalnik do sporzadzania zawiesiny do wstrzykiwan w ampulko-strzykawce, Szczepionka przeciw zóltej febrze, zywa. STAMARIL Pulbere şi solvent pentru suspensie injectabilă în seringă preumplută, Vaccin pentru febra galbenă (viu) STAMARIL Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension in einer Fertigspritze GelbfieberLebendimpfstoff STAMARIL Pulveris un šķīdinātājs injekciju suspensijas pagatavošanai pilnšļircē.Yellow fever vaccine (Live) STAMARIL süstesuspensiooni pulber ja lahusti süstlis, Kollapalavikuvaktsiin (Elus) STAMARIL, poeder en oplosmiddel voor suspensie voor injectie in voorgevulde spuit. Gelekoortsvaccin (levend) STAMARIL, polvere e solvente per sospensione iniettabile in siringa preriempita

List of nationally authorised medicinal products EMA/579275/2017

MRP/DCP Authorisation number

National Authorisation Number

DE/H/0476/001

OGYI-T-20076/012

DE/H/0476/001

OGYI-T-20076/001

not available

HR-H-497248499

SA SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR SA

DE/H/0476/001

59/068/99-C

SANOFI PASTEUR SA

CZ

DE/H/0476/001

59/0048/03-S

SANOFI PASTEUR SA

SK

DE/H/0476/001

R/6610

DE/H/0476/001

278/2007/01-09

DE/H/0476/001

178A/94

DE/H/0476/001

97-0411

DE/H/0476/001

301900

DE/H/0476/001

BE185062

DE/H/0476/001

026970020

MAH of product in the member state

SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR EUROPE SANOFI PASTEUR SA SANOFI PASTEUR SA SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE

Member State where product is authorised

HU HU HR

PL RO DE LV EE BE IT

Page 3/5

Product Name (in authorisation country)

Vaccino della febbre gialla (Vivo) STAMARIL, polvere e solvente per sospensione iniettabile in siringa preriempita Vaccino della febbre gialla (Vivo) STAMARIL, polvo y disolvente para suspensión inyectable en jeringa precargada Vacuna (viva) frente a la fiebre amarilla STAMARIL, poudre et solvant pour suspension injectable en récipient multidose, Vaccin de la fièvre jaune (Vivant) STAMARIL, poudre et solvant pour suspension injectable en seringue préremplie. Vaccin de la fièvre jaune (Vivant) STAMARIL, poudre et solvant pour suspension injectable en seringue préremplie, Vaccin de la fièvre jaune (Vivant) STAMARIL, poudre et solvant pour suspension injectable en seringue préremplie Vaccin de la fièvre jaune (Vivant) STAMARIL, powder and solvent for suspension for injection in a pre-filled syringe Yellow fever vaccine (Live) STAMARIL, powder and solvent for suspension for injection in pre-filled syringe Yellow fever vaccine (Live) STAMARIL, powder and solvent for suspension for injection in pre-filled syringe. Yellow fever vaccine (Live) STAMARIL, pulver och vätska till injektionsvätska, suspension i förfylld spruta Vaccin mot gula febern, levande STAMARIL, pulver och vätska till injektionsvätska, suspension i förfylld spruta. Vaccin mot gula febern, levande Stamaril, pulver og solvens til injektionsvæske, suspension i fyldt sprøjte Gul feber vaccine (levende) STAMARIL, pulver og væske til injeksjonsvæske, suspensjon i ferdigfylt sprøyte Vaksine mot gulfeber (levende) STAMARIL, Pulver und Lösungsmittel zur Herstellung einer List of nationally authorised medicinal products EMA/579275/2017

MRP/DCP Authorisation number

National Authorisation Number

DE/H/0476/001

026970032

DE/H/0476/001

65.098

not available

NL 11 824

DE/H/0476/001

BE 185062

DE/H/0476/001

NL 14 156

DE/H/0476/001

0491/08100050

DE/H/0476/001

MA 573/00601

DE/H/0476/001

PA 2131/008/001

DE/H/0476/001

PL 46602/0007

DE/H/0476/001

11678

DE/H/0476/001

12086

DE/H/0476/001

14880

DE/H/0476/001 DE/H/0476/001

8196 2-00298

MAH of product in the member state

SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR SA SANOFI PASTEUR EUROPE SANOFI PASTEUR SA SANOFI PASTEUR EUROPE SANOFI PASTEUR SA SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR

Member State where product is authorised

IT ES FR BE FR LU MT IE UK FI SE DK NO AT

Page 4/5

Product Name (in authorisation country)

Injektionssuspension Gelbfieber-Lebendimpfstoff STAMARIL, Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension in einer Fertigspritze GelbfieberLebendimpfstoff STAMARIL, Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension in einer Fertigspritze GelbfieberLebendimpfstoff STAMARIL, stungulyfsstofn og leysir, dreifa, í áfylltri sprautu. Bóluefni við gulusótt (lifandi) STAMARIL,pó e veículo para suspensão injetável em seringa pré-cheia Vacina (viva) contra a febre-amarela STAMARIL,pó e veículo para suspensão injetável em seringa pré-cheia Vacina (viva) contra a febre-amarela STAMARIL,pó e veículo para suspensão injetável em seringa pré-cheia Vacina (viva) contra a febre-amarela STAMARIL,pó e veículo para suspensão injetável em seringa pré-cheia Vacina (viva) contra a febre-amarela СТАМАРИЛ прах и разтворител за инжекционна суспензия Ваксина срещу жълта треска, жива

List of nationally authorised medicinal products EMA/579275/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

EUROPE

DE/H/0476/001

BE185062

DE/H/0476/001

0491/08100050

DE/H/0476/001

930056

DE/H/0476/001

5614888

DE/H/0476/001

5615083

DE/H/0476/001

5614987

DE/H/0476/001

3792181

DE/H/0476/001

20000831

SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR EUROPE SANOFI PASTEUR SA

BE LU IS PT PT PT PT BG

Page 5/5

yellow fever vaccine - European Medicines Agency - Europa EU

Sep 1, 2017 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525. Send a question via our website www.ema.europa.eu/contact. © European ...

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