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Biocidal product factsheet - Last updated: 28/04/2023

Biocidal Product details

Trade name:

-

IR3535 Cream

JUNGLE FORMULA szúnyogriasztó krém

Mousti K.O crème anti-moustiques bébés et femmes enceintes

Moustikologne Haute tolérance crème bébé

Product-type:

PT19

Active Substance details

Substance name:

Ethyl butylacetylaminopropionate

IUPAC name:

ethyl N-acetyl-N-butyl-β-alaninate

EC number:

-; 257-835-0

CAS number:

52304-36-6

BAS number:

1320

Authorised
map
Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

20111202-NL-0016700-0000_Final PAR (public).pdf (en)

6 authorisations in the product cluster
Trade name
Product-type
Market area
Authorisation holder
Authorisation number
Authorisation start
Authorisation end
SPC Decisions
Authorisation status
R4BP 3 asset
National

Moustikologne Haute tolérance crème bébé
PT19

Netherlands

 Omega Pharma International n.v. NL-0016700-0004 - 02/12/2022 02/12/2032

Family SPC  (en)

Member SPC  (en)

20221202_NL-0016700-0000_Authorisation.pdf (nl)

 Authorised

-
PT19

Belgium

 Omega Pharma International n.v. BE-0017255-0004 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 Cream
PT19

Czech Republic

 Omega Pharma International n.v. CZ-0030184-0004 CZ-0030184-0000 02/12/2022 02/12/2032

Family SPC  (cs)

Member SPC  (cs)

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

 Authorised

JUNGLE FORMULA szúnyogriasztó krém
PT19

Hungary

 Omega Pharma International n.v. HU-0030517-0004 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

Mousti K.O crème anti-moustiques bébés et femmes enceintes
PT19

Luxembourg

 Omega Pharma International n.v. LU-0013488-0004 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

Moustikologne Haute tolérance crème bébé
PT19

Slovenia

 Omega Pharma International n.v. SI-0030287-0004 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
Reference authorisation
Trade name: Moustikologne Haute tolérance crème bébé
Authorisation number: NL-0016700-0004| 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

Family SPC  (en)

Member SPC  (en)

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-0017255-0004| 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 Cream
Authorisation number: CZ-0030184-0004| Market area: Czech Republic

1 assessment record available

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

Family SPC  (cs)

Member SPC  (cs)

Trade name: JUNGLE FORMULA szúnyogriasztó krém
Authorisation number: HU-0030517-0004| 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: Mousti K.O crème anti-moustiques bébés et femmes enceintes
Authorisation number: LU-0013488-0004| 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: Moustikologne Haute tolérance crème bébé
Authorisation number: SI-0030287-0004| 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)