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Biocidal product factsheet - Last updated: 26/02/2024

Biocidal Product details

Trade name:

APOBAS GEL

BRODITEC GEL-50

BRODITOP GEL

DEVILTOP GEL

MASSORRAT SOFT

MS RODETOX BRODI ACTIVE GEL

MS RODETOX BRODI CRèME

PROTEMAX GEL BF50

Ratron® Power-Paste RattenMäuseKöder

RODETOX BRODI CREAM

RODIBROD GEL HC

ROMAX VENOM PASTE

SAKARAT BRODIFACOUM GEL

SANIFAR GEL

Product-type:

PT14

Active Substance details

Substance name:

Brodifacoum

IUPAC name:

3-[3-(4'-bromobiphenyl- 4-yl)-1,2,3,4-tetrahydro -1-napthyl]-4-hydroxycoumarin

EC number:

259-980-5

CAS number:

56073-10-0

BAS number:

The Active Substance is a candidate for substitution

Authorised

Expired

Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

9 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
BRODITOP GEL MS RODETOX BRODI ACTIVE GEL ROMAX VENOM PASTE	PT14	United Kingdom	ZAPI S.p.A.	R4BP 3 asset	National	UK-0004941-0000	UK-2016-1041	18/11/2016	31/12/2020	SPC not available	Expired
BRODITEC GEL-50 BRODITOP GEL DEVILTOP GEL SANIFAR GEL	PT14	France	ZAPI S.p.A.	FR-0017482-0000	FR-2018-0004	18/11/2016	27/01/2026	Single SPC (fr)	BRODITOPGE_BC-DE032320-73_NA-MRS_D2.pdf (fr) (19/04/2018) BRODITOPGE_BC-DE032320-73_NA-MRS_D.pdf (fr) (09/03/2018) BRODITOPGE_BC-EG080120-64_NA-ADC_D.pdf (fr) BRODITOPGE_BC-QE051660-47_NA-RNL_D.pdf (fr)	Authorised
BRODITEC GEL-50 BRODITOP GEL DEVILTOP GEL MS Rodetox Brodi Active Gel Ratron® Power-Paste RattenMäuseKöder RODETOX BRODI CREAM	PT14	Germany	ZAPI S.p.A.	DE-0005121-0000	DE-0005121-14	18/11/2016	27/01/2026	Single SPC (de)		Authorised
BRODITEC GEL-50 BRODITOP GEL SAKARAT BRODIFACOUM GEL	PT14	Ireland	ZAPI S.p.A.	IE-0027662-0000	IE/BPA 70830	10/12/2021	27/01/2026	Single SPC (en)	IE-BPA 70830 Authorisation Certificate.pdf (en)	Authorised
BRODITEC GEL-50 BRODITOP GEL DEVILTOP GEL PROTEMAX GEL BF50 RODETOX BRODI CREAM RODIBROD GEL HC	PT14	Italy	ZAPI S.p.A.	IT-0005122-0000	it/2017/00394/mrp	18/11/2016	27/01/2026	Language Single SPC (it) Single SPC (en)	broditop gel2.pdf (it) broditop gel.pdf (it)	Authorised
BRODITOP GEL MS Rodetox Brodi Active Gel	PT14	Netherlands	ZAPI S.p.A.	NL-0005124-0000	-	18/11/2016	27/01/2026	Single SPC (nl)	Authorisation BRODITOP GEL 20145052.doc (nl) (23/02/2017) 210402 NL 0005124 BESL.pdf (nl) 20221212 - ZAPI- amendment.pdf (nl) 181116_NL-0005124-0000_art48 change.doc (nl) 20201009_NL-0005124-0000_Procedural prolongation.pdf (nl)	Authorised
BRODITOP GEL	PT14	Norway	ZAPI S.p.A.	NO-0005123-0000	NO-2017-0127	18/11/2016	18/11/2026	Single SPC (no)	Broditop Gel_authorisation letter_NO.pdf (en) (26/01/2017) NO-0005123-0000_extended expiry date.pdf (en) Broditop Gel_authorisation.pdf (en)	Authorised
BRODITOP GEL MS RODETOX BRODI CRèME	PT14	Poland	ZAPI S.p.A.	PL-0005125-0000	PL/2017/0259/MR	21/08/2017	27/01/2026	Single SPC (pl)	PL.2017.0259.MR.pdf (pl) (25/08/2017) PB.PL.2017.0259.MR.pow.15.2021 Broditop Gel.pdf (pl) PB.PL.2017.0259.MR.pow.32.2020 Broditop Gel.pdf (pl) PB.PL.2017.0259.MR.z1.73.2022__NA-ADC_D.pdf (pl) PB.PL.2017.0259.MR Broditop Gel RNL.pdf (pl)	Authorised
APOBAS GEL BRODITOP GEL DEVILTOP GEL MASSORRAT SOFT RODETOX BRODI CREAM	PT14	Spain	ZAPI S.p.A.	ES-0005127-0000	ES/MR(NA)-2021-14-00401	18/11/2016	27/01/2026	Single SPC (es)	00401 BRODITOP GEL. DEVILTOP GEL. RODETOX BRODI CREAM. MASSORRAT SOFT.pdf (es) (04/08/2017) 00401 Broditop Gel.pdf (es) (07/03/2017) R4BP_ES-0005127-0000_Authorisation.pdf (es) R4BP3-ES-005127-0000-Authorisation.pdf (es) R4BP_ES-0005127-0000_Authorisation.pdf (es)	Authorised

Reference authorisation

Trade name: BRODITOP GEL , MS RODETOX BRODI ACTIVE GEL , ROMAX VENOM PASTE
Authorisation number: UK-0004941-0000| Market area: United Kingdom

5 assessment records available

Renewal of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

22/12/2020

Validity of authorisation

Start date:

18/11/2016

End date:

16/12/2025

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

27/10/2020

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2022

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

13/12/2018

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

22/05/2018

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Application of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

28/11/2016

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Mutual recognition

Trade name: BRODITEC GEL-50 , BRODITOP GEL , DEVILTOP GEL , SANIFAR GEL
Authorisation number: FR-0017482-0000| Market area: France

7 assessment records available

National authorisation administrative change on request

Evaluating authority:

France

Conclusion date:

19/10/2022

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

Single SPC (fr)

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

23/02/2022

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

SPC not available

Renewal of national authorisation

Evaluating authority:

France

Conclusion date:

16/04/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

18/11/2020

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2021

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

17/07/2019

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

19/04/2018

Validity of authorisation

Start date:

09/03/2018

End date:

18/11/2020

SPC

SPC not available

Mutual recognition in sequence

Evaluating authority:

France

Conclusion date:

09/03/2018

Validity of authorisation

Start date:

09/03/2018

End date:

18/11/2020

SPC

SPC not available

Trade name: BRODITEC GEL-50 , BRODITOP GEL , DEVILTOP GEL , MS Rodetox Brodi Active Gel , Ratron® Power-Paste RattenMäuseKöder , RODETOX BRODI CREAM
Authorisation number: DE-0005121-0000| Market area: Germany

7 assessment records available

National authorisation administrative change on request

Evaluating authority:

Germany

Conclusion date:

14/02/2023

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

Single SPC (de)

Renewal of national authorisation

Evaluating authority:

Germany

Conclusion date:

22/02/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Germany

Conclusion date:

09/10/2020

Validity of authorisation

Start date:

18/11/2016

End date:

05/04/2021

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Germany

Conclusion date:

03/08/2018

Validity of authorisation

Start date:

14/12/2016

End date:

18/11/2020

SPC

SPC not available

National authorisation administrative change on request

Evaluating authority:

Germany

Conclusion date:

26/06/2017

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

National authorisation administrative change on request

Evaluating authority:

Germany

Conclusion date:

12/05/2017

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Germany

Conclusion date:

14/12/2016

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Trade name: BRODITEC GEL-50 , BRODITOP GEL , SAKARAT BRODIFACOUM GEL
Authorisation number: IE-0027662-0000| Market area: Ireland

2 assessment records available

Amendment of national authorisation

Evaluating authority:

Ireland

Conclusion date:

14/04/2022

Validity of authorisation

Start date:

10/12/2021

End date:

27/01/2026

SPC

Single SPC (en)

Mutual recognition in sequence

Evaluating authority:

Ireland

Conclusion date:

10/12/2021

Validity of authorisation

Start date:

10/12/2021

End date:

27/01/2026

SPC

SPC not available

Trade name: BRODITEC GEL-50 , BRODITOP GEL , DEVILTOP GEL , PROTEMAX GEL BF50 , RODETOX BRODI CREAM , RODIBROD GEL HC
Authorisation number: IT-0005122-0000| Market area: Italy

11 assessment records available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

02/02/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

Language

Single SPC (it)

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

02/02/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

28/01/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

27/01/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

15/12/2020

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2022

SPC

SPC not available

Renewal of national authorisation

Evaluating authority:

Italy

Conclusion date:

05/10/2020

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2022

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

29/10/2018

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2022

SPC

SPC not available

National authorisation administrative change on request

Evaluating authority:

Italy

Conclusion date:

29/10/2018

Validity of authorisation

Start date:

18/11/2016

End date:

31/08/2020

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

03/04/2017

Validity of authorisation

Start date:

18/11/2016

End date:

31/08/2020

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

22/03/2017

Validity of authorisation

Start date:

18/11/2016

End date:

31/08/2020

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Italy

Conclusion date:

15/03/2017

Validity of authorisation

Start date:

18/11/2016

End date:

31/08/2020

SPC

SPC not available

Trade name: BRODITOP GEL , MS Rodetox Brodi Active Gel
Authorisation number: NL-0005124-0000| Market area: Netherlands

5 assessment records available

Amendment of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

13/12/2022

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

Single SPC (nl)

Renewal of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

01/04/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

12/10/2020

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2022

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

15/11/2018

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Netherlands

Conclusion date:

23/02/2017

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Trade name: BRODITOP GEL
Authorisation number: NO-0005123-0000| Market area: Norway

4 assessment records available

Amendment of national authorisation

Evaluating authority:

Norway

Conclusion date:

14/03/2022

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2026

SPC

Single SPC (no)

Renewal of national authorisation

Evaluating authority:

Norway

Conclusion date:

22/02/2022

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Norway

Conclusion date:

13/10/2020

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2022

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Norway

Conclusion date:

26/01/2017

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Trade name: BRODITOP GEL , MS RODETOX BRODI CRèME
Authorisation number: PL-0005125-0000| Market area: Poland

6 assessment records available

National authorisation administrative change on request

Evaluating authority:

Poland

Conclusion date:

28/07/2022

Validity of authorisation

Start date:

21/08/2017

End date:

27/01/2026

SPC

Single SPC (pl)

Renewal of national authorisation

Evaluating authority:

Poland

Conclusion date:

01/10/2021

Validity of authorisation

Start date:

21/08/2017

End date:

27/01/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Poland

Conclusion date:

30/09/2021

Validity of authorisation

Start date:

21/08/2017

End date:

18/10/2021

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Poland

Conclusion date:

24/06/2021

Validity of authorisation

Start date:

21/08/2017

End date:

30/09/2021

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Poland

Conclusion date:

17/11/2020

Validity of authorisation

Start date:

21/08/2017

End date:

30/06/2021

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Poland

Conclusion date:

25/08/2017

Validity of authorisation

Start date:

21/08/2017

End date:

18/11/2020

SPC

SPC not available

Trade name: APOBAS GEL , BRODITOP GEL , DEVILTOP GEL , MASSORRAT SOFT , RODETOX BRODI CREAM
Authorisation number: ES-0005127-0000| Market area: Spain

11 assessment records available

Renewal of national authorisation

Evaluating authority:

Spain

Conclusion date:

16/06/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

Single SPC (es)

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

16/06/2021

Validity of authorisation

Start date:

18/11/2016

End date:

27/01/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

03/12/2020

Validity of authorisation

Start date:

18/11/2016

End date:

02/06/2021

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

17/11/2020

Validity of authorisation

Start date:

18/11/2016

End date:

04/12/2020

SPC

SPC not available

National authorisation administrative change on request

Evaluating authority:

Spain

Conclusion date:

01/09/2020

Validity of authorisation

Start date:

07/02/2017

End date:

18/11/2020

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

12/07/2018

Validity of authorisation

Start date:

07/02/2017

End date:

18/11/2020

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

12/07/2018

Validity of authorisation

Start date:

02/02/2017

End date:

18/11/2020

SPC

SPC not available

National authorisation administrative change on request

Evaluating authority:

Spain

Conclusion date:

04/08/2017

Validity of authorisation

Start date:

18/11/2016

End date:

31/08/2020

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

07/03/2017

Validity of authorisation

Start date:

18/11/2016

End date:

31/08/2020

SPC

SPC not available

Transfer of a national authorisation

Evaluating authority:

Spain

Conclusion date:

07/03/2017

Validity of authorisation

Start date:

18/11/2016

End date:

31/08/2020

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Spain

Conclusion date:

16/02/2017

Validity of authorisation

Start date:

18/11/2016

End date:

31/08/2020

SPC

SPC not available