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

Biocidal Product details

Trade name:

OMEGA PHARMA IR3535

Paranit fejtetű riasztó pumpás aeroszol

Paranit Preventivní sprej proti vším

Paranit Preventívny sprej proti všiam

Paranit Repelent

Paranit zaščita pred ušmi

Paranix Head Lice Protection

Paranix Head Lice Repellent

PARANIX Kopflaus Repellent Spray

Paranix Prevent

Paranix Prevention

Paranix Protect

Paranix Protection

Paranix Protection, Repel, Prevent

Paranix Repel

Paranix Repellent

Paranix répulsif anti-poux

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
map
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
R4BP 3 asset
National

Paranix Prevent

Paranix Protect

Paranix Repel
PT19

Belgium

 Omega Pharma International n.v. BE-0017255-0005 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

PARANIX Kopflaus Repellent Spray
PT19

Switzerland

 Omega Pharma International n.v. CH-0028726-0005 CH-2023-0014 07/06/2023 02/12/2032

Family SPC  (de)

Member SPC  (de)

 Authorised

Paranit Preventivní sprej proti vším
PT19

Czech Republic

 Perrigo Supply Chain International DAC CZ-0030184-0005 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

Paranix répulsif anti-poux
PT19

France

 Omega Pharma International n.v. FR-0013745-0005 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

Paranix Head Lice Protection

Paranix Head Lice Repellent

Paranix Prevent

Paranix Protection

Paranix Repel
PT19

Greece

 Omega Pharma International n.v. GR-0020736-0005 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

Paranit fejtetű riasztó pumpás aeroszol
PT19

Hungary

 Omega Pharma International n.v. HU-0030517-0005 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

Paranix Prevention
PT19

Italy

 Omega Pharma International n.v. IT-0014992-0005 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

Paranix Repellent
PT19

Luxembourg

 Omega Pharma International n.v. LU-0013488-0005 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

Paranix Head Lice Protection

Paranix Head Lice Repellent

Paranix Protection, Repel, Prevent
PT19

Netherlands

 Omega Pharma International n.v. NL-0016700-0005 - 02/12/2022 02/12/2032

Family SPC  (en)

Member SPC  (en)

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

 Authorised

Paranit zaščita pred ušmi
PT19

Slovenia

 Omega Pharma International n.v. SI-0030287-0005 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

Paranit Preventívny sprej proti všiam

Paranit Repelent
PT19

Slovakia

 Perrigo Supply Chain International DAC SK-0030903-0005 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
Reference authorisation
Trade name: Paranix Head Lice Protection , Paranix Head Lice Repellent , Paranix Protection, Repel, Prevent
Authorisation number: NL-0016700-0005| 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: Paranix Prevent , Paranix Protect , Paranix Repel
Authorisation number: BE-0017255-0005| 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: Paranit Preventivní sprej proti vším
Authorisation number: CZ-0030184-0005| 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 , Paranix répulsif anti-poux
Authorisation number: FR-0013745-0005| 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: Paranix Head Lice Protection , Paranix Head Lice Repellent , Paranix Prevent , Paranix Protection , Paranix Repel
Authorisation number: GR-0020736-0005| 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: Paranit fejtetű riasztó pumpás aeroszol
Authorisation number: HU-0030517-0005| 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: Paranix Prevention
Authorisation number: IT-0014992-0005| 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: Paranix Repellent
Authorisation number: LU-0013488-0005| 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: Paranit Preventívny sprej proti všiam , Paranit Repelent
Authorisation number: SK-0030903-0005| 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: Paranit zaščita pred ušmi
Authorisation number: SI-0030287-0005| 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: PARANIX Kopflaus Repellent Spray
Authorisation number: CH-0028726-0005| 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)