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Biocidal product factsheet - Last updated: 08/04/2024

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

Substance name:

Ethyl butylacetylaminopropionate

IUPAC name:

ethyl 3-(N-butylacetamido)propanoate

EC number:

257-835-0

CAS number:

52304-36-6

BAS number:

1320

Authorised

Expired

Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

BE2019-0057_PAR.pdf (en)

BE2019-0057_PAR_Public.docx (en)

20 authorisations in the product cluster

Trade name	Product-type	Market area	Authorisation holder	Authorisation number		Authorisation start	Authorisation end	SPC	Decisions	Authorisation status
Trade name	Product-type	Market area	Authorisation holder	R4BP 3 asset	National	Authorisation start	Authorisation end	SPC	Decisions	Authorisation status
Insect Repellent Lotion IR3535 10%	PT19	Austria	Merck KGaA	R4BP 3 asset	National	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	Belgium	Merck KGaA	BE-0013102-0000	BE2019-0057	07/11/2019	04/11/2029	Jezik Single SPC (en) Single SPC (nl) Single SPC (fr) Single SPC (de)	BE2019-0057_Act.pdf (en)	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)	Lettera invio e decreto NA-MIC - Insect Repellent Lotion IR3535 10 per cento - BC-CN087097-26.pdf (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

Jezik

Single SPC (en)

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

4 assessment records available

National authorisation minor change on request

Evaluating authority:

Italy

Conclusion date:

05/04/2024

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:

26/07/2021

Validity of authorisation

Start date:

07/11/2019

End date:

04/11/2029

SPC

SPC not available

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