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

Biocidal Product details

Trade name:

Paranit fejtetű riasztó pumpás aeroszol

Paranit Preventivní sprej proti vším

Paranit zaščita pred ušmi

Paranix Head Lice Protection

Paranix Head Lice Repellent

Paranix Prevent

Paranix Protect

Paranix Protection, Repel, Prevent

Paranix Repel

Paranix Repellent

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

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
Trade name	Product-type	Market area	Authorisation holder	R4BP 3 asset	National	Authorisation start	Authorisation end	SPC	Decisions	Authorisation status
Paranix Head Lice Protection Paranix Head Lice Repellent Paranix Protection, Repel, Prevent	PT19	Netherlands	Omega Pharma International n.v.	R4BP 3 asset	National	NL-0016700-0005	-	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
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	Language Family SPC (nl) Member SPC (nl) Family SPC (fr) Member SPC (fr) Family SPC (de) Member SPC (de)	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
Paranit Preventivní sprej proti vším	PT19	Czech Republic	Omega Pharma International n.v.	CZ-0030184-0005	CZ-0030184-0000	02/12/2022	02/12/2032	Family SPC (cs) Member SPC (cs)	podminky-povoleni_PUBLIC_CZ-0030184-0000.pdf (cs)	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 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
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

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

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: 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

Language

Family SPC (nl)

Member SPC (nl)

Trade name: Paranit Preventivní sprej proti vším
Authorisation number: CZ-0030184-0005| 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: 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 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 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)