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

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

neautorizované pre oblasť trhu Slovenská republika

OMEGA PHARMA IR3535

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

Cancelled

Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

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

11 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
Moustikologne Haute tolérance crème bébé	PT19	Netherlands	Omega Pharma International n.v.	R4BP 3 asset	National	NL-0016700-0004	-	02/12/2022	02/12/2032	Language Family SPC (en) Member SPC (en) Family SPC (nl) Member SPC (nl)	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	Language Family SPC (nl) Member SPC (nl) Family SPC (de) Member SPC (de) Family SPC (fr) Member SPC (fr)	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	Perrigo Supply Chain International DAC	CZ-0030184-0004	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-0013745-0004	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
-	PT19	Greece	Omega Pharma International n.v.	GR-0020736-0004	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	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
-	PT19	Italy	Omega Pharma International n.v.	IT-0014992-0004	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
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
neautorizované pre oblasť trhu Slovenská republika	PT19	Slovakia	Perrigo Supply Chain International DAC	SK-0030903-0004	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
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
Moustikologne Haute tolérance crème bébé	PT19	Switzerland	Omega Pharma International n.v.	CH-0028726-0004	CH-2023-0014	07/06/2023	02/12/2032	SPC not available		Cancelled

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

Language

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

Language

Family SPC (nl)

Member SPC (nl)

Trade name: IR3535 Cream
Authorisation number: CZ-0030184-0004| 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-0013745-0004| 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: -
Authorisation number: GR-0020736-0004| 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
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: -
Authorisation number: IT-0014992-0004| 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: 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: neautorizované pre oblasť trhu Slovenská republika
Authorisation number: SK-0030903-0004| 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: 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)

Trade name: Moustikologne Haute tolérance crème bébé
Authorisation number: CH-0028726-0004| 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

SPC not available