Allergens for Sublingual Immune Therapy
Allergens for Sublingual Immune Therapy
Therapy allergens are used for Allergen immunotherapy (AIT) in order to restore tolerance to the respective allergen.
In the case of the sublingual immune therapy (also called sublingual hyposensitisation) the allergen extract is placed under the tongue several times a day and swallowed over a longer period of time (as al rule for several years).
Therapy allergens for the sublingual immune therapy are available for the following allergen classes:
- Tree Pollen
- Grass-, Cereal and Herbal Pollen
- House Dust Mites and Storage Mites
top
Tree Pollen
Tree Pollen
Approved Allergens for Sublingual Immune Therapy against Tree Pollen
Name
|
Marketing Authorisation Holder
|
License Number
|
License Date
|
Further Information
|
ITULAZAX
|
CC-Pharma GmbH
|
PEI.H.12102.01.1 |
22.04.2021 |
|
ITULAZAX
|
EurimPharm Arzneimittel GmbH
|
PEI.H.12073.01.1 |
10.12.2020 |
|
ITULAZAX
|
AxiCorp Pharma GmbH
|
PEI.H.12070.01.1 |
23.12.2020 |
|
ITULAZAX
|
Abacus Medicine A/S
|
PEI.H.12083.01.1 |
08.02.2021 |
|
ITULAZAX
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.12081.01.1 |
11.02.2021 |
|
ITULAZAX
|
ALK-Abelló Arzneimittel GmbH
|
PEI.H.11987.01.1 |
29.07.2019 |
PharmNet.Bund
|
ITULAZAX
|
kohlpharma GmbH
|
PEI.H.12043.01.1 |
19.05.2020 |
|
ITULAZAX
|
Orifarm GmbH
|
PEI.H.12045.01.1 |
24.08.2020 |
|
ITULAZAX
|
BB Farma s.r.l., Italien
|
PEI.H.12167.01.1 |
20.04.2023 |
|
Staloral Birke 10 IR/ml und 300 IR/ml
|
Stallergenes Greer
|
PEI.H.03013.05.1 |
27.04.2005 |
PharmNet.Bund
|
Staloral Birke 300 IR/ml
|
Stallergenes Greer
|
PEI.H.03013.03.1 |
10.08.2004 |
PharmNet.Bund
|
Staloral Birke/Erle/Hasel 10 IR/ml
|
Stallergenes Greer
|
PEI.H.03012.01.1 |
10.08.2004 |
PharmNet.Bund
|
Staloral Birke/Erle/Hasel 300 IR/ml
|
Stallergenes Greer
|
PEI.H.03012.03.1 |
10.08.2004 |
PharmNet.Bund
|
SUBLIVAC Bäume
|
HAL Allergy B.V.
|
PEI.H.07974.02.1 |
02.08.2018 |
PharmNet.Bund
|
SUBLIVAC Birke
|
HAL Allergy B.V.
|
PEI.H.07972.02.1 |
02.08.2018 |
PharmNet.Bund
|
Disclaimer
The list of medicines contains the products that have a valid marketing authorization. It contains no information as to whether the preparations are available on the market.
The information contained in the Federal Gazette, which is the official publication organ of the Paul-Ehrlich-Institut, is legally binding.
As of: PEI announcement No. 519 in BAnz AT 26.07.2024 B6.
Summary of Product Characteristics (SmPCs) and the Package Leaflet (PL)
Where the European Medicines Agency (EMA) offers further information, you will find a link to the EPAR (European public assessment report) in the table.
If user and technical information or public assessment reports are available in PharmNet.Bund, the Federal and State Pharmaceutical Information Portal, these are directly linked to PharmNet.Bund in the table.
top
Grass- / Cereal- / Herbal Pollen
Grass- / Cereal- / Herbal Pollen
Approved Allergens for Sublingual Immune Therapy against Grass-, Cereal- and Herbal Pollen
Name
|
Marketing Authorisation Holder
|
License Number
|
License Date
|
Further Information
|
GRAZAX
|
kohlpharma GmbH
|
PEI.H.11647.01.1 |
22.07.2013 |
PharmNet.Bund
|
Grazax
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.11855.01.1 |
13.06.2016 |
|
GRAZAX
|
CC-Pharma GmbH
|
PEI.H.11730.01.1 |
16.01.2015 |
PharmNet.Bund
|
Grazax
|
ALK-Abelló Arzneimittel GmbH
|
PEI.H.03489.01.1 |
20.10.2006 |
PharmNet.Bund
|
Grazax
|
A.C.A Müller ADAG Pharma AG
|
PEI.H.11886.01.1 |
09.12.2016 |
PharmNet.Bund
|
GRAZAX
|
Abacus Medicine A/S
|
PEI.H.11865.01.1 |
04.04.2017 |
PharmNet.Bund
|
Grazax
|
Orifarm GmbH
|
PEI.H.11617.01.1 |
20.03.2014 |
PharmNet.Bund
|
GRAZAX
|
FD Pharma GmbH
|
PEI.H.12175.01.1 |
23.05.2023 |
PharmNet.Bund
|
Grazax 75.000 SQ-T
|
AxiCorp Pharma GmbH
|
PEI.H.11700.01.1 |
04.12.2014 |
PharmNet.Bund
|
Grazax 75.000 SQ-T
|
EurimPharm Arzneimittel GmbH
|
PEI.H.11712.01.1 |
28.07.2014 |
PharmNet.Bund
|
GRAZAX 75000 SQ-T Lyophilisat zum Einnehmen
|
Medicopharm AG
|
PEI.H.11889.01.1 |
09.12.2016 |
PharmNet.Bund
|
Grazax Lyo Tablette
|
Pharma Gerke GmbH
|
PEI.H.11632.01.1 |
22.07.2013 |
PharmNet.Bund
|
Oralair 100 IR & 300 IR
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.11812.02.1 |
24.04.2018 |
PharmNet.Bund
|
Oralair 100 IR & 300 IR
|
kohlpharma GmbH
|
PEI.H.11735.01.1 |
22.06.2015 |
PharmNet.Bund
|
Oralair 100 IR & 300 IR
|
European Pharma B.V., Niederlande
|
PEI.H.11776.01.1 |
06.07.2015 |
PharmNet.Bund
|
Oralair 100 IR & 300 IR
|
Medicopharm AG
|
PEI.H.11868.01.1 |
13.10.2016 |
PharmNet.Bund
|
Oralair 100 IR & 300 IR
|
EurimPharm Arzneimittel GmbH
|
PEI.H.11797.01.1 |
17.09.2015 |
PharmNet.Bund
|
Oralair 100 IR & 300 IR
|
2Care4 ApS, Dänemark
|
PEI.H.12027.01.1 |
07.08.2020 |
|
Oralair 100 IR & 300 IR
|
Stallergenes Greer
|
PEI.H.03450.01.1 |
24.06.2008 |
PharmNet.Bund
|
Oralair 100 IR & 300 IR
|
Orifarm GmbH
|
PEI.H.11822.01.1 |
06.05.2016 |
PharmNet.Bund
|
Oralair 300 IR
|
kohlpharma GmbH
|
PEI.H.11735.02.1 |
22.06.2015 |
PharmNet.Bund
|
Oralair 300 IR
|
European Pharma B.V., Niederlande
|
PEI.H.11776.02.1 |
12.12.2016 |
PharmNet.Bund
|
Oralair 300 IR
|
CC Pharma GmbH
|
PEI.H.11875.01.1 |
05.12.2016 |
PharmNet.Bund
|
Oralair 300 IR
|
AxiCorp Pharma GmbH
|
PEI.H.11897.01.1 |
05.12.2016 |
PharmNet.Bund
|
Oralair 300 IR
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.11812.01.1 |
13.06.2016 |
PharmNet.Bund
|
Disclaimer
The list of medicines contains the products that have a valid marketing authorization. It contains no information as to whether the preparations are available on the market.
The information contained in the Federal Gazette, which is the official publication organ of the Paul-Ehrlich-Institut, is legally binding.
As of: PEI announcement No. 519 in BAnz AT 26.07.2024 B6.
Summary of Product Characteristics (SmPCs) and the Package Leaflet (PL)
Where the European Medicines Agency (EMA) offers further information, you will find a link to the EPAR (European public assessment report) in the table.
If user and technical information or public assessment reports are available in PharmNet.Bund, the Federal and State Pharmaceutical Information Portal, these are directly linked to PharmNet.Bund in the table.
House Dust Mites
House Dust Mites
Approved Allergens for Sublingual Immune Therapy against House Dust Mites
Name
|
Marketing Authorisation Holder
|
License Number
|
License Date
|
Further Information
|
ACARIZAX 12 SQ-HDM
|
ALK-Abelló, DK-Horsholm
|
PEI.H.11754.01.1 |
08.10.2015 |
PharmNet.Bund
|
AITARO 12 SQ-HDM
|
ALK-Abelló, DK-Horsholm
|
PEI.H.11820.01.1 |
29.12.2015 |
PharmNet.Bund
|
AMITEND 12 SQ-HDM Lyophilisat
|
ALK-Abelló, DK-Horsholm
|
PEI.H.11821.01.1 |
29.12.2015 |
PharmNet.Bund
|
ACARIZAX 12 SQ-HDM
|
CC-Pharma GmbH
|
PEI.H.12126.01.1 |
14.09.2021 |
PharmNet.Bund
|
Orylmyte 300 IR
|
CC-Pharma GmbH
|
PEI.H.12190.01.1 |
09.10.2023 |
|
Orylmyte 100 IR & 300 IR
|
CC-Pharma GmbH
|
PEI.H.12190.02.1 |
09.10.2023 |
|
ACARIZAX 12 SQ-HDM
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.12108.01.1 |
23.04.2021 |
|
Orylmyte 300 IR
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.12177.01.1 |
23.05.2023 |
|
Orylmyte 100 IR & 300 IR
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.12177.02.1 |
24.08.2023 |
|
ACARIZAX 12 SQ-HDM
|
EurimPharm Arzneimittel GmbH
|
PEI.H.12004.01.1 |
04.07.2019 |
PharmNet.Bund
|
Orylmyte 100 IR & 300 IR
|
EurimPharm Arzneimittel GmbH
|
PEI.H.12192.02.1 |
14.11.2023 |
|
Orylmyte 300 IR
|
EurimPharm Arzneimittel GmbH
|
PEI.H.12192.01.1 |
14.11.2023 |
|
Orylmyte 100 IR & 300 IR
|
kohlpharma GmbH
|
PEI.H.12149.01.1 |
25.07.2022 |
|
Orylmyte 300 IR
|
kohlpharma GmbH
|
PEI.H.12149.02.1 |
02.08.2022 |
|
Acarizax 12 SQ-HDM
|
Orifarm GmbH
|
PEI.H.12049.01.1 |
10.12.2020 |
|
Orylmyte 100 IR & 300 IR
|
Orifarm GmbH
|
PEI.H.12186.01.1 |
09.10.2023 |
|
Orylmyte 300 IR
|
Stallergenes Greer
|
PEI.H.12040.03.1 |
09.07.2021 |
PharmNet.Bund
|
Orylmyte 100 IR & 300 IR
|
Stallergenes Greer
|
PEI.H.12040.02.1 |
09.07.2021 |
PharmNet.Bund
|
Orylmyte 100 IR
|
Stallergenes Greer
|
PEI.H.12040.01.1 |
09.07.2021 |
PharmNet.Bund
|
ACARIZAX 12 SQ-HDM
|
kohlpharma GmbH
|
PEI.H.12042.01.1 |
04.08.2020 |
|
Disclaimer
The list of medicines contains the products that have a valid marketing authorization. It contains no information as to whether the preparations are available on the market.
The information contained in the Federal Gazette, which is the official publication organ of the Paul-Ehrlich-Institut, is legally binding.
As of: PEI announcement No. 519 in BAnz AT 26.07.2024 B6.
Summary of Product Characteristics (SmPCs) and the Package Leaflet (PL)
Where the European Medicines Agency (EMA) offers further information, you will find a link to the EPAR (European public assessment report) in the table.
If user and technical information or public assessment reports are available in PharmNet.Bund, the Federal and State Pharmaceutical Information Portal, these are directly linked to PharmNet.Bund in the table.
top