Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.

Biocidal product factsheet - Last updated: 14/06/2024

Biocidal Product details

Trade name:

-

/

Azaron 0% DEET lotion

Azaron 20% IR3535 lotion

Azaron Anti Muggenlotion Kids

Azaron Anti-Muggen Baby & Kids lotion

Azaron Outdoor & Camping lotion

Azaron sensitive lotion

IR3535 Lotion

Jungle Formula 20% IR3535 lotion

Jungle Formula Anti Muggenlotion Kids

Jungle Formula Anti-Muggen Baby & Kids lotion

Jungle Formula for sensitive skin

Jungle Formula Kids Lotion

Jungle Formula Outdoor & Camping lotion

Jungle Formula Sensitive Lotion

JUNGLE FORMULA szúnyogriasztó krém (lotion)

Jungle Formula voor de gevoelige huid

Kruidvat sensitive lotion

neautorizované pre oblasť trhu Slovenská republika

OMEGA PHARMA IR3535

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
Cancelled
map
Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

11 authorisations in the product cluster
Authorisation number SPC Decisions

Azaron 0% DEET lotion

Azaron 20% IR3535 lotion

Azaron Anti Muggenlotion Kids

Azaron Anti-Muggen Baby & Kids lotion

Azaron Outdoor & Camping lotion

Azaron sensitive lotion

Jungle Formula 20% IR3535 lotion

Jungle Formula Anti Muggenlotion Kids

Jungle Formula Anti-Muggen Baby & Kids lotion

Jungle Formula for sensitive skin

Jungle Formula Outdoor & Camping lotion

Jungle Formula Sensitive Lotion

Jungle Formula voor de gevoelige huid

Kruidvat sensitive lotion

PT19

Netherlands

Omega Pharma International n.v. NL-0016700-0001 - 02/12/2022 02/12/2032

SPC not available

Cancelled

/

PT19

Belgium

Omega Pharma International n.v. BE-0017255-0001 BE2023-0001-00-00 02/12/2022 02/12/2032

Family SPC  (nl)

Member SPC  (nl)

BE2023-0001-01-00_Act (NL).pdf (nl)

BE2023-0001-01-01_Act (NL).pdf (nl)

BE2023-0001-00-00_Act (NL).pdf (nl)

Authorised

IR3535 Lotion

PT19

Czech Republic

Perrigo Supply Chain International DAC CZ-0030184-0001 CZ-0030184-0000 02/12/2022 02/12/2032

Family SPC  (cs)

Member SPC  (cs)

podminky-povoleni__Omega_Pharma.pdf (cs)

podminky-povoleni_PUBLIC_CZ-0030184-0000.pdf (cs)

Authorised

OMEGA PHARMA IR3535

PT19

France

Omega Pharma International n.v. FR-0013745-0001 FR-2023-0040 28/06/2023 02/12/2032

Family SPC  (fr)

Member SPC  (fr)

OMEGA PHARMA IR3535 BPF_BC-YJ020341-42_NA-MRP_D2.pdf (fr)

OMEGAPHARM_BC-YJ020341-42_NA-MRP_D.pdf (fr)

Authorised

Jungle Formula for sensitive skin

Jungle Formula Kids Lotion

Jungle Formula Outdoor & Camping lotion

Jungle Formula Sensitive Lotion

PT19

Greece

Omega Pharma International n.v. GR-0020736-0001 ΤΠ19-0461-OΠ (Omega Pharma IR3535) 23/06/2023 02/12/2032

Family SPC  (el)

Member SPC  (el)

OMEGA PHARMA IR3535_VAR SEPT 2023.pdf (el)

OMEGA PHARMA IR3535 BPF MRP.pdf (el)

Authorised

JUNGLE FORMULA szúnyogriasztó krém (lotion)

PT19

Hungary

Omega Pharma International n.v. HU-0030517-0001 HU-2023-MA-19-00444-BF 02/12/2022 02/12/2032

Family SPC  (hu)

Member SPC  (hu)

Omega Pharma IR3535_authorization.pdf (hu)

Authorised

-

PT19

Italy

Omega Pharma International n.v. IT-0014992-0001 IT/2023/00899/MRP 01/09/2023 02/12/2032

Family SPC  (it)

Member SPC  (it)

Decreto BC-JC020347-59 - Omega Pharma IR3535 - NA-MRP.pdf (it)

Authorised

Jungle Formula kids lotion

PT19

Luxembourg

Omega Pharma International n.v. LU-0013488-0001 13/23/L-M00-000 16/01/2023 02/12/2032

Family SPC  (fr)

Member SPC  (fr)

AMM_13_23_L-M00-000_OmegaPharmaIR3535.pdf (fr)

Authorised

neautorizované pre oblasť trhu Slovenská republika

PT19

Slovakia

Perrigo Supply Chain International DAC SK-0030903-0001 SK24-004-00-000 06/02/2024 02/12/2032

Family SPC  (sk)

Member SPC  (sk)

NA-TRS_supplement_no_1_Omega_Pharma_IR3535.pdf (sk)

NA-MRS_authorisation_Omega Pharma IR3535.pdf (sk)

Authorised

Jungle Formula 20% IR3535 lotion

Jungle Formula Anti Muggenlotion Kids

Jungle Formula Anti-Muggen Baby & Kids lotion

Jungle Formula for sensitive skin

Jungle Formula Sensitive Lotion

PT19

Slovenia

Omega Pharma International n.v. SI-0030287-0001 SI-0030287-0000 24/03/2023 02/12/2032

Family SPC  (sl)

Member SPC  (sl)

Omega_Pharma__OMEGA_PHARMA_IR3535__MRP_SI-0030287_P.pdf (sl)

Authorised

Jungle Formula Kids Lotion

PT19

Switzerland

Omega Pharma International n.v. CH-0028726-0001 CH-2023-0014 07/06/2023 02/12/2032

Family SPC  (de)

Member SPC  (de)

Authorised
Reference authorisation
Trade name: Azaron 0% DEET lotion , Azaron 20% IR3535 lotion , Azaron Anti Muggenlotion Kids , Azaron Anti-Muggen Baby & Kids lotion , Azaron Outdoor & Camping lotion , Azaron sensitive lotion , Jungle Formula 20% IR3535 lotion , Jungle Formula Anti Muggenlotion Kids , Jungle Formula Anti-Muggen Baby & Kids lotion , Jungle Formula for sensitive skin , Jungle Formula Outdoor & Camping lotion , Jungle Formula Sensitive Lotion , Jungle Formula voor de gevoelige huid , Kruidvat sensitive lotion
Authorisation number: NL-0016700-0001| Market area: Netherlands

2 assessment records available

Amendment of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

20/12/2022

Validity of authorisation

Start date:

02/12/2022

End date:

02/12/2032

SPC

SPC not available

Application of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

01/12/2022

Validity of authorisation

Start date:

02/12/2022

End date:

02/12/2032

SPC

SPC not available

Mutual recognition
Trade name: /
Authorisation number: BE-0017255-0001| Market area: Belgium

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Belgium

Conclusion date:

27/04/2023

Validity of authorisation

Start date:

02/12/2022

End date:

02/12/2032

SPC

Family SPC  (nl)

Member SPC  (nl)

Trade name: IR3535 Lotion
Authorisation number: CZ-0030184-0001| Market area: Czech Republic

2 assessment records available

Transfer of a national authorisation

Evaluating authority:

Czech Republic

Conclusion date:

28/03/2024

Validity of authorisation

Start date:

02/12/2022

End date:

02/12/2032

SPC

Family SPC  (cs)

Member SPC  (cs)

Mutual recognition in parallel

Evaluating authority:

Czech Republic

Conclusion date:

27/02/2023

Validity of authorisation

Start date:

02/12/2022

End date:

02/12/2032

SPC

SPC not available

Trade name: OMEGA PHARMA IR3535
Authorisation number: FR-0013745-0001| Market area: France

2 assessment records available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

22/11/2023

Validity of authorisation

Start date:

28/06/2023

End date:

02/12/2032

SPC

Family SPC  (fr)

Member SPC  (fr)

Mutual recognition in parallel

Evaluating authority:

France

Conclusion date:

11/07/2023

Validity of authorisation

Start date:

28/06/2023

End date:

02/12/2032

SPC

SPC not available

Trade name: Jungle Formula for sensitive skin , Jungle Formula Kids Lotion , Jungle Formula Outdoor & Camping lotion , Jungle Formula Sensitive Lotion
Authorisation number: GR-0020736-0001| Market area: Greece

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Greece

Conclusion date:

14/09/2023

Validity of authorisation

Start date:

23/06/2023

End date:

02/12/2032

SPC

Family SPC  (el)

Member SPC  (el)

Mutual recognition in parallel

Evaluating authority:

Greece

Conclusion date:

23/06/2023

Validity of authorisation

Start date:

23/06/2023

End date:

02/12/2032

SPC

SPC not available

Trade name: JUNGLE FORMULA szúnyogriasztó krém (lotion)
Authorisation number: HU-0030517-0001| Market area: Hungary

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Hungary

Conclusion date:

10/03/2023

Validity of authorisation

Start date:

02/12/2022

End date:

02/12/2032

SPC

Family SPC  (hu)

Member SPC  (hu)

Trade name: -
Authorisation number: IT-0014992-0001| Market area: Italy

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Italy

Conclusion date:

12/09/2023

Validity of authorisation

Start date:

01/09/2023

End date:

02/12/2032

SPC

Family SPC  (it)

Member SPC  (it)

Trade name: Jungle Formula kids lotion
Authorisation number: LU-0013488-0001| Market area: Luxembourg

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Luxembourg

Conclusion date:

03/02/2023

Validity of authorisation

Start date:

16/01/2023

End date:

02/12/2032

SPC

Family SPC  (fr)

Member SPC  (fr)

Trade name: neautorizované pre oblasť trhu Slovenská republika
Authorisation number: SK-0030903-0001| Market area: Slovakia

2 assessment records available

Transfer of a national authorisation

Evaluating authority:

Slovakia

Conclusion date:

05/04/2024

Validity of authorisation

Start date:

06/02/2024

End date:

02/12/2032

SPC

Family SPC  (sk)

Member SPC  (sk)

Mutual recognition in sequence

Evaluating authority:

Slovakia

Conclusion date:

06/02/2024

Validity of authorisation

Start date:

06/02/2024

End date:

02/12/2032

SPC

SPC not available

Trade name: Jungle Formula 20% IR3535 lotion , Jungle Formula Anti Muggenlotion Kids , Jungle Formula Anti-Muggen Baby & Kids lotion , Jungle Formula for sensitive skin , Jungle Formula Sensitive Lotion
Authorisation number: SI-0030287-0001| Market area: Slovenia

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Slovenia

Conclusion date:

07/04/2023

Validity of authorisation

Start date:

24/03/2023

End date:

02/12/2032

SPC

Family SPC  (sl)

Member SPC  (sl)

Trade name: Jungle Formula Kids Lotion
Authorisation number: CH-0028726-0001| Market area: Switzerland

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Switzerland

Conclusion date:

07/06/2023

Validity of authorisation

Start date:

07/06/2023

End date:

02/12/2032

SPC

Family SPC  (de)

Member SPC  (de)