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Biocidal product factsheet - Last updated: 22/03/2024

Biocidal Product details

Trade name:

(Magyarországon) IR3535 10% szúnyog- és kullancsriasztó krém

-

Insect Repellent Lotion IR3535 10%

INSECT REPELLENT LOTION IR3535®10%

Product-type:

PT19

Active Substance details

IUPAC name:

ethyl 3-(N-butylacetamido)propanoate

EC number:

257-835-0

CAS number:

52304-36-6

BAS number:

1320

Authorised
Expired
map
Authorisation information

Authorisation type:

National authorisation

Legal act:

20 authorisations in the product cluster
Authorisation number SPC Decisions

Insect Repellent Lotion IR3535 10%

PT19

Belgium

Merck KGaA BE-0013102-0000 BE2019-0057 07/11/2019 04/11/2029

Single SPC  (fr)

BE2019-0057_Act.pdf (en)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Austria

Merck KGaA AT-0013473-0000 AT-0013473-0000 07/11/2019 02/03/2030

Single SPC  (de)

2020-0.139.334_-_Merck_KGaA_-_Bescheid.pdf (de)

Insect_Repellent_Lotion_IR3535_10_Anlage_1.pdf (de)

2020-0.409.714_-_Berichtigungsbescheid_.pdf (de)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Cyprus

Merck KGaA CY-0024798-0000 ΚΥ-0184 19/02/2021 04/11/2029

Single SPC  (el)

Insect Repellent Lotion IR3535 10.pdf (el)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Czech Republic

Merck KGaA CZ-0026294-0000 CZ-0026294-0000 07/11/2019 04/11/2029

Single SPC  (cs)

podminky-povoleni_PUBLIC_CZ-0026294-0000.pdf (cs)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Estonia

Merck KGaA EE-0013330-0000 EE-0013330-0000 07/11/2019 04/11/2029

Single SPC  (et)

NA-AAT Insect Repellent Lotion IR3535 10.pdf (et)

NA-MRP luba Insect Repellent Lotion IR3535 10_ 17-02-2020.pdf (et)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Finland

Merck KGaA FI-0023827-0000 FI-2020-0012 08/05/2020 04/11/2029

Single SPC  (fi)

paatos_Insect_Rep_Lotion_IR3535_10_20200508.pdf (fi)

Authorised

INSECT REPELLENT LOTION IR3535 10%

PT19

France

Merck KGaA FR-0012881-0000 FR-2020-0029 13/08/2020 04/11/2029

Single SPC  (fr)

INSECTREPE_BC-LK020011-62_NA-MRP_D.pdf (fr)

INSECTREPE_BC-XF087098-19_NA-MIC_D.pdf (fr)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Germany

Merck KGaA DE-0013071-0000 DE-0013071-19 27/05/2020 04/11/2029

Single SPC  (de)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Greece

Merck KGaA GR-0020734-0000 ΤΠ19-0347 26/03/2020 04/11/2029

Single SPC  (el)

INSECT REPELLENT LOTION IR3535 10_MRP.pdf (el)

INSECT REPELLENT LOTION IR3535 10_MRP_ΟΡΘΗ ΕΠΑΝΑΛΗΨΗ (22-06-2020).pdf (el)

Authorised

(Magyarországon) IR3535 10% szúnyog- és kullancsriasztó krém

PT19

Hungary

Merck KGaA HU-0024856-0000 HU-2020-MA-19-00313-0000 07/11/2019 04/11/2029

Single SPC  (hu)

47919-5-2020-KBKHF_decision.pdf (hu)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Italy

Merck KGaA IT-0024986-0000 it/2020/0609/mrp 07/11/2019 04/11/2029

Single SPC  (it)

doc02391720210726153435.pdf (it)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Latvia

Merck KGaA LV-0013293-0000 LV/2019/MR/015 07/11/2019 04/11/2029

Single SPC  (lv)

MerckKGaA_InsectRepellentLotionIR3535_NA-MRP_LV.pdf (lv)

MerckKGaA_InsectRepellentLotionIR3535_NA-MRP_EN.pdf (en)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Lithuania

Merck KGaA LT-0024136-0000 (10-14 17.5 E)BPR-304(A-19VAP1143557-20-147) 09/06/2020 04/11/2029

Single SPC  (lt)

AL Insect Repellent Lotion 2020-06-09.pdf (lt)

Authorised

-

PT19

Malta

Merck KGaA MT-0025228-0000 2021-07-06-B02 06/07/2021 04/11/2029

Single SPC  (en)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Netherlands

Merck KGaA NL-0021571-0000 - 07/11/2019 04/11/2029

Single SPC  (nl)

200626_nl-0021571_administrative change.pdf (nl)

20191127_NL-0021571-0000_Authorisation.pdf (nl)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Portugal

Merck KGaA PT-0031884-0000 PT/DGS ARMPB-04/2023-rev 07/11/2019 04/11/2029

Single SPC  (pt)

Authorised

INSECT REPELLENT LOTION IR3535®10%

PT19

Spain

Merck KGaA ES-0021815-0000 ES/MR(NA)-2020-19-00715 07/11/2019 04/11/2029

Single SPC  (es)

R4BP-ES-0021815-0000-Authorisation.pdf (es)

R4BP3-ES-0021815-0000-v1.pdf (es)

R4BP3-ES-0021815-0000-v2.pdf (es)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Sweden

Merck KGaA SE-0022115-0000 5594 15/01/2020 04/11/2029

Single SPC  (sv)

5594_Beslut_2020-01-15.pdf (sv)

Authorised

Insect Repellent Lotion IR3535 10%

PT19

Switzerland

Merck KGaA CH-0028928-0000 CH-2022-0016 29/06/2022 04/11/2029

Single SPC  (de)

Authorised

-

PT19

United Kingdom

Merck KGaA UK-0021740-0000 UK-2019-1226 07/11/2019 31/12/2020

SPC not available

Expired
Reference authorisation
Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: BE-0013102-0000| Market area: Belgium

8 assessment records available

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

16/01/2024

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (fr)

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

16/01/2024

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

National authorisation minor change on request

Evaluating authority:

Belgium

Conclusion date:

20/11/2023

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

16/01/2023

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

09/01/2023

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

18/06/2020

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

05/11/2019

Validity of authorisation

Start date:

04/11/2019

End date:

04/11/2029

SPC

SPC not available

Application of national authorisation

Evaluating authority:

Belgium

Conclusion date:

04/11/2019

Validity of authorisation

Start date:

04/11/2019

End date:

04/11/2029

SPC

SPC not available

Mutual recognition
Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: AT-0013473-0000| Market area: Austria

2 assessment records available

Amendment of national authorisation

Evaluating authority:

Austria

Conclusion date:

09/07/2020

Validity of authorisation

Start date:

07/11/2019

End date:

02/03/2030

SPC

Single SPC  (de)

Mutual recognition in parallel

Evaluating authority:

Austria

Conclusion date:

12/03/2020

Validity of authorisation

Start date:

02/03/2020

End date:

02/03/2030

SPC

SPC not available

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: CY-0024798-0000| Market area: Cyprus

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Cyprus

Conclusion date:

22/02/2021

Validity of authorisation

Start date:

19/02/2021

End date:

04/11/2029

SPC

Single SPC  (el)

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: CZ-0026294-0000| Market area: Czech Republic

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Czech Republic

Conclusion date:

23/04/2021

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (cs)

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: EE-0013330-0000| Market area: Estonia

2 assessment records available

Amendment of national authorisation

Evaluating authority:

Estonia

Conclusion date:

30/06/2020

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (et)

Mutual recognition in parallel

Evaluating authority:

Estonia

Conclusion date:

20/02/2020

Validity of authorisation

Start date:

17/02/2020

End date:

04/11/2029

SPC

SPC not available

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: FI-0023827-0000| Market area: Finland

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Finland

Conclusion date:

08/05/2020

Validity of authorisation

Start date:

08/05/2020

End date:

04/11/2029

SPC

Single SPC  (fi)

Trade name: INSECT REPELLENT LOTION IR3535 10%
Authorisation number: FR-0012881-0000| Market area: France

5 assessment records available

National authorisation minor change on request

Evaluating authority:

France

Conclusion date:

05/02/2024

Validity of authorisation

Start date:

13/08/2020

End date:

04/11/2029

SPC

Single SPC  (fr)

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

23/07/2021

Validity of authorisation

Start date:

13/08/2020

End date:

04/11/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

22/07/2021

Validity of authorisation

Start date:

13/08/2020

End date:

04/11/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

21/07/2021

Validity of authorisation

Start date:

08/07/2021

End date:

04/11/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

France

Conclusion date:

14/08/2020

Validity of authorisation

Start date:

13/08/2020

End date:

04/11/2029

SPC

SPC not available

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: DE-0013071-0000| Market area: Germany

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Germany

Conclusion date:

18/12/2023

Validity of authorisation

Start date:

27/05/2020

End date:

04/11/2029

SPC

Single SPC  (de)

Amendment of national authorisation

Evaluating authority:

Germany

Conclusion date:

23/06/2020

Validity of authorisation

Start date:

27/05/2020

End date:

04/11/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Germany

Conclusion date:

27/05/2020

Validity of authorisation

Start date:

27/05/2020

End date:

04/11/2029

SPC

SPC not available

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: GR-0020734-0000| Market area: Greece

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Greece

Conclusion date:

25/06/2020

Validity of authorisation

Start date:

26/03/2020

End date:

04/11/2029

SPC

Single SPC  (el)

Amendment of national authorisation

Evaluating authority:

Greece

Conclusion date:

24/06/2020

Validity of authorisation

Start date:

26/03/2020

End date:

04/11/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Greece

Conclusion date:

13/05/2020

Validity of authorisation

Start date:

26/03/2020

End date:

04/11/2029

SPC

SPC not available

Trade name: (Magyarországon) IR3535 10% szúnyog- és kullancsriasztó krém
Authorisation number: HU-0024856-0000| Market area: Hungary

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Hungary

Conclusion date:

17/11/2020

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (hu)

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: IT-0024986-0000| Market area: Italy

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

26/07/2021

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (it)

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

23/07/2021

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Italy

Conclusion date:

19/10/2020

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: LV-0013293-0000| Market area: Latvia

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Latvia

Conclusion date:

21/03/2024

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (lv)

Amendment of national authorisation

Evaluating authority:

Latvia

Conclusion date:

18/08/2020

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Latvia

Conclusion date:

03/12/2019

Validity of authorisation

Start date:

03/12/2019

End date:

04/11/2029

SPC

SPC not available

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: LT-0024136-0000| Market area: Lithuania

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Lithuania

Conclusion date:

10/06/2020

Validity of authorisation

Start date:

09/06/2020

End date:

04/11/2029

SPC

Single SPC  (lt)

Trade name: -
Authorisation number: MT-0025228-0000| Market area: Malta

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Malta

Conclusion date:

23/07/2021

Validity of authorisation

Start date:

06/07/2021

End date:

04/11/2029

SPC

Single SPC  (en)

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: NL-0021571-0000| Market area: Netherlands

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

29/06/2020

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (nl)

Amendment of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

29/06/2020

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Netherlands

Conclusion date:

05/12/2019

Validity of authorisation

Start date:

06/12/2019

End date:

04/11/2029

SPC

SPC not available

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: PT-0031884-0000| Market area: Portugal

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Portugal

Conclusion date:

26/11/2023

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (pt)

Trade name: INSECT REPELLENT LOTION IR3535®10%
Authorisation number: ES-0021815-0000| Market area: Spain

4 assessment records available

National authorisation minor change on request

Evaluating authority:

Spain

Conclusion date:

13/12/2023

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

Single SPC  (es)

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

13/12/2023

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

09/06/2023

Validity of authorisation

Start date:

06/08/2020

End date:

04/11/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Spain

Conclusion date:

10/08/2020

Validity of authorisation

Start date:

06/08/2020

End date:

04/11/2029

SPC

SPC not available

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: SE-0022115-0000| Market area: Sweden

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Sweden

Conclusion date:

15/01/2020

Validity of authorisation

Start date:

15/01/2020

End date:

04/11/2029

SPC

Single SPC  (sv)

Trade name: Insect Repellent Lotion IR3535 10%
Authorisation number: CH-0028928-0000| Market area: Switzerland

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Switzerland

Conclusion date:

29/06/2022

Validity of authorisation

Start date:

29/06/2022

End date:

04/11/2029

SPC

Single SPC  (de)

Trade name: -
Authorisation number: UK-0021740-0000| Market area: United Kingdom

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

United Kingdom

Conclusion date:

13/11/2019

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available