01 September 2017 EMA/596847/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet)

Procedure no.: PSUSA/00010465/201612

3 0 Churchill P lace ● C anary Wharf ● L ondon E14 5EU ● U nited Kingdom Telephone +4 4 (0 )20 3660 6 000 Facsimile +4 4 (0 )20 3660 5 525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© E uropean M edic ines A genc y, 2 0 1 7 . Reproduc tion is authoris ed provided the s ourc e is ac knowledged.

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

Keolium 100 IR/ 300 IR comprimidos sublinguais Tratamento de iniciação Keollum 300 IR comprimidos subllnguals Tratamento de continuação Keollum 300 IR comprimidos subllnguals Tratamento de continuação ORALAIR 100 IR & 300 IR compresse sublinguali Inizio del trattamento ORALAIR 100 IR & 300 IR poliežuvinės tabletės ORALAIR 100 IR & 300 IR Sublingualtabletten ORALAIR 100 IR & 300 IR Sublingualtabletten Einleitungsbehandlung Oralair 100 IR & 300 IR sublingválne tablety Iniciacná liecba ORALAIR 100 IR & 300 IR tabletes lietošanai zem mēles Ārstēšanas uzsākšanai ORALAIR 100 IR & 300 IR tabletten voor sublinguaal gebruik Startbehandeling ORALAIR 100 IR & 300 IR tabletten voor sublinguaal gebruik Startbehandeling ORALAIR 100 IR & 300 IR, 100 IR / 300 IR, tabletki podjezykowe Leczenie wstepne

DE/H/1930/001

5426440

STALLERGENES

PT

DE/1930/002

5426424

STALLERGENES

PT

DE/H/1930/002

5426432

STALLERGENES

PT

DE/H/1930/001

039857014

STALLERGENES

IT

DE/H/1930/001

LT/1/10/2024/001

STALLERGENES

LT

DE/1930/001/MR

BE364515

STALLERGENES

BE

DE/1930/001

PEI.H.03450.01.1

STALLERGENES

DE

DE/1930/001

59/0853/09-S

STALLERGENES

SK

DE/H/1930/001

10-0048

STALLERGENES

LV

DE/H/1930/001

RVG 105376

STALLERGENES

NL

DE/1930/001

BE364515

STALLERGENES

BE

DE/H/1930/001

16729

STALLERGENES

PL

L is t of nationally authorised medicinal products E MA/596847/2017

P age 2 /6

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

ORALAIR 100 IR & 300 IR, comprimés sublinguaux Traitement d’initiation ORALAIR 100 IR & 300 IR, comprimés sublinguaux Traitement d'initiation ORALAIR 100 IR & 300 IR, comprimés sublinguaux Traitement d'initiation ORALAIR 100 IR & 300 IR, keelealused tabletid Ravi alustamine ORALAIR 100 IR + 300 IR Sublingualtabletten Einleitungsbehandlung ORALAIR 100 IR és 300 IR nyelvalatti tabletta Kezdo kezelés ORALAIR 100 IR in 300 IR podjezične tablete začetno zdravljenje ORALAIR 100 IR&300 IR, sublingvální tablety Úvodní lécba ORALAIR 100IR & 300IR comprimate sublinguale Tratament de initiere Oralair 100IR & 300IR sublingual tablets Initiation treatment ORALAIR 300 IR compresse sublinguali Prosecuzione del trattamento

DE/H/1930/001

2010050081

STALLERGENES

LU

DE/1930/001

BE364515

STALLERGENES

BE

DE/1930/001

3400936895164

STALLERGENES

FR

DE/1930/001

672810

STALLERGENES

EE

DE/1930/001

2-00361

STALLERGENES

AT

DE/H/1930/001

OGYI-T-21527/01

STALLERGENES

HU

DE/H/1930/001

5363-I-421/14

STALLERGENES

SI

DE/H/1930/001

59/160/10-C

STALLERGENES

CZ

DE/H/1930/002

5858/2013/01

STALLERGENES

RO

DE/H/1930/001

PA2113/001/001

STALLERGENES

IE

DE/H/1930/002

039857026

STALLERGENES

IT

L is t of nationally authorised medicinal products E MA/596847/2017

P age 3 /6

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

ORALAIR 300 IR compresse sublinguali Prosecuzione del trattamento ORALAIR 300 IR comprimate sublinguale Tratament de continuare ORALAIR 300 IR comprimate sublinguale Tratament de continuare ORALAIR 300 IR comprimidos sublinguales Tratamiento de continuación ORALAIR 300 IR nyelvalatti tabletta Fenntartó kezelés ORALAIR 300 IR nyelvalatti tabletta Fenntartó kezelés ORALAIR 300 IR podjezicne tablete nadaljevalno zdravljenje ORALAIR 300 IR podjezicne tablete nadaljevalno zdravljenje ORALAIR 300 IR poliežuvinės tabletės ORALAIR 300 IR poliežuvinės tabletės Oralair 300 IR sublingual tablets C ontinuation treatment ORALAIR 300 IR Sublingualtabletten

DE/H/1930/002

039857038

STALLERGENES

IT

DE/H/1930/002

5859/2013/01

STALLERGENES

RO

DE/1930/002

5859/2013/02

STALLERGENES

RO

DE/1930/002

71954

STALLERGENES

ES

DE/H/1930/002

OGYI-T-21527/02

STALLERGENES

HU

DE/1930/002

OGYI-T-21527/03

STALLERGENES

HU

DE/H/1930/002

5363-I-422/14

STALLERGENES

SI

DE/H/1930/002

5363-I-423/14

STALLERGENES

SI

DE/1930/002

LT/1/10/2024/003

STALLERGENES

LT

DE/1930/002

LT/1/10/2024/002

STALLERGENES

LT

DE/H/1930/002

PA2113/001/002

STALLERGENES

IE

DE/1930/002/MR

BE364524

STALLERGENES

BE

L is t of nationally authorised medicinal products E MA/596847/2017

P age 4 /6

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

ORALAIR 300 IR Sublingualtabletten Fortsetzungsbehandlung ORALAIR 300 IR Sublingualtabletten Fortsetzungsbehandlung Oralair 300 IR sublingválne tablety Pokracovanie liecby ORALAIR 300 IR tabletes lietošanai zem mēles Ārstēšanas turpināšanai ORALAIR 300 IR tabletten voor sublinguaal gebruik Vervolgbehandeling ORALAIR 300 IR tabletten voor sublinguaal gebruik Vervolgbehandeling ORALAIR 300 IR, comprimés sublinguaux Traitement d’entretien ORALAIR 300 IR, comprimés sublinguaux Traitement d’entretien ORALAIR 300 IR, comprimés sublinguaux Traitement d’entretien ORALAIR 300 IR, comprimés sublinguaux Traitement d'entretien ORALAIR 300 IR, comprimés sublinguaux Traitement d'entretien ORALAIR 300 IR, keelealused tabletid Jätkuravi

DE/H/1930/002

2 – 00362

STALLERGENES

AT

DE/1930/002

PEI.H.03450.02.1

STALLERGENES

DE

DE/1930/002

59/0854/09-S

STALLERGENES

SK

DE/H/1930/002

10-0049

STALLERGENES

LV

DE/H/1930/002

BE364524

STALLERGENES

BE

DE/H/1930/002

RVG 105380

STALLERGENES

NL

DE/H/1930/002

BE364524

STALLERGENES

BE

DE/H/1930/002

2010050082

STALLERGENES

LU

DE/H/1930/002

2010050082

STALLERGENES

LU

DE/H/1930/002

34009 368 952 2 5

STALLERGENES

FR

DE/1930/002

3400936895393

STALLERGENES

FR

DE/H/1930/002

672910

STALLERGENES

EE

L is t of nationally authorised medicinal products E MA/596847/2017

P age 5 /6

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

ORALAIR 300 IR, sublingvální tablety Udržovací lécba ORALAIR 300 IR, tabletki podjezykowe Kontynuacja leczenia ORALAIR INIC IO 100 IR y 300 IR comprimidos sublinguales Tratamiento de inicio ОРАЛАИР 100 IR и 300 IR сублингвални таблетки Първоначално лечение ОРАЛАИР 300 IR сублингваЛIIИ таблетки Прод ължава що лечение

DE/H/1930/002

59/159/10-C

STALLERGENES

CZ

DE/H/1930/002

16730

STALLERGENES

PL

DE/1930/001

71953

STALLERGENES

ES

DE/1930/001

20100376

STALLERGENES

BG

DE/1930/002

20100374

STALLERGENES

BG

L is t of nationally authorised medicinal products E MA/596847/2017

P age 6 /6

Allergen for therapy - European Medicines Agency - Europa EU

Sep 1, 2017 - E MA /596847/2017. P age 2 /6. Product Name (in authorisation country). MRP/DCP Authorisation number. National Authorisation. Number.

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