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Biocidal product factsheet - Last updated: 27/06/2024

Biocidal Product details

Trade name:

Exittus

Relpexa

REPLEXA rágcsálóirtó pép

Selontra

SELONTRA rágcsálóirtó pép

Selontra,

Selontra, Relpexa

Product-type:

PT14

Active Substance details

Substance name:

Cholecalciferol

IUPAC name:

(1S,3Z)-3-{2-[(1R,3aS,4E,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-octahydro-1H-inden-4-ylidene]ethylidene}-4-methylidenecyclohexan-1-ol

EC number:

200-673-2

CAS number:

67-97-0

BAS number:

1443

The Active Substance is a candidate for substitution

Authorised

Expired

Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

Selontra_fPAR__Oct_2020_non_confidential.pdf (en)

Selontra_Final_public_PAR_sanitized_22122022_decisiondate_30012023.pdf (en)

28 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
Exittus Relpexa Selontra	PT14	Finland	BASF OY	R4BP 3 asset	National	FI-0023556-0000	FI-2020-0009, FI-2020-0010, FI-2020-0011	28/04/2020	27/04/2025	Jazyk Single SPC (fi) Single SPC (en)	Selontra_NAMIC_30012023.pdf (fi) Selontra_kansallinen_lupa_20200428.pdf (fi)	Authorised
Relpexa Selontra	PT14	Austria	BASF SE	AT-0023568-0000	AT-0023568-0000	28/04/2020	27/04/2025	Single SPC (de)	Bescheid_Selontra_2020-0.732.756.pdf (de) 2024-0.039.982_Aenderungsbescheid.pdf (de) Selontra_Aenderungsbescheid_2023-0.915.590.pdf (de) Selontra_Anlage_1_Berichtigung.pdf (de)	Authorised
Relpexa Selontra	PT14	Belgium	BASF Belgium Coordination Center,	BE-0024691-0000	BE2020-0032	28/04/2020	27/04/2025	Jazyk Single SPC (nl) Single SPC (fr) Single SPC (de)	BE2020-0032_Act(FR)_Selontra.pdf (fr)	Authorised
Relpexa Selontra	PT14	Bulgaria	BASF EOOD	BG-0023577-0000	2806-1	05/06/2020	27/04/2025	Jazyk Single SPC (en) Single SPC (bg)		Authorised
Relpexa Selontra	PT14	Croatia	BASF Croatia d.o.o.	HR-0023573-0000	KLASA:UP/-543-04/20-12/15	28/04/2020	27/04/2025	Single SPC (hr)	rjesenje_Selontra_HR_MIC.pdf (hr) basf-rjesenje-selontra.pdf (hr)	Authorised
Relpexa Selontra,	PT14	Cyprus	BASF HELLAS Single Member Industrial and Commercial S.A.	CY-0023566-0000	ΚΥ-0190	10/03/2021	27/04/2025	Single SPC (el)	Selontra.pdf (el) Selontra_MIC.pdf (el)	Authorised
Relpexa Selontra	PT14	Czech Republic	BASF spol. s r.o.	CZ-0023561-0000	CZ-0023561-0000	28/04/2020	27/04/2025	Single SPC (cs)	podminky-povoleni_PUBLIC_13892-2022.doc.pdf (cs) podminky_public_Selontra.pdf (cs) podminky-povoleni_PUBLIC_Selontra.pdf (cs)	Authorised
Exittus Relpexa Selontra	PT14	Denmark	BASF A/S	DK-0023560-0000	19-254	28/04/2020	27/04/2025	Single SPC (da)	Selontra (19-254) - NA-MIC - Godkendelse (rettet 17.05.23).pdf (da) Selontra (19-254) - NA-MIC - Godkendelse.pdf (da) Selontra_PT14 Godkendelsesbrev.pdf (da)	Authorised
Exittus Relpexa Selontra,	PT14	Estonia	BASF UAB	EE-0023565-0000	EE-0023565-0000	27/05/2020	27/04/2025	Single SPC (et)	NA-TRS luba Selontra 26.01.2024.pdf (et) NA-MIC luba Selontra 17.03.2023.pdf (et) NA-MRP luba Selontra 27.05 2020.pdf (et)	Authorised
RELPEXA SELONTRA	PT14	France	BASF France SAS	FR-0023558-0000	FR-2020-0021	19/06/2020	27/04/2025	Single SPC (fr)	SELONTRA_BC-FQ050110-50_NA-MRP_D2.pdf (fr) SELONTRA_BC-FQ050110-50_NA-MRP_D.pdf (fr) SELONTRA_BC-BM075231-47_NA-MIC_D.pdf (fr)	Authorised
Relpexa Selontra	PT14	Germany	BASF SE	DE-0023567-0000	DE-0023567-14	11/05/2020	27/04/2025	Single SPC (de)		Authorised
Relpexa Selontra,	PT14	Greece	BASF HELLAS Single Member Industrial and Commercial S.A.	GR-0023562-0000	ΤΠ14-0173	19/06/2020	27/04/2025	Single SPC (el)	SELONTRA_MRP_CORRIGENDUM.pdf (el) SELONTRA_VAR MARCH 2023.pdf (el)	Authorised
REPLEXA rágcsálóirtó pép SELONTRA rágcsálóirtó pép	PT14	Hungary	BASF Hungaria Kft	HU-0023580-0000	HU-2020-MA-14-00295-0000	28/04/2020	27/04/2025	Single SPC (hu)	702-6_2020_KBKHF_Selontra r�gcs�l�irt� p�p_decision.pdf (hu) 02538-3-2023-KBKHF_Selontra_MIC_hat�rozat.pdf (hu)	Authorised
Selontra, Relpexa	PT14	Ireland	BASF Ireland DAC	IE-0023581-0000	IE/BPA 70751	28/04/2020	27/04/2025	Single SPC (en)	IE-BPA 70751 Authorisation Certificate Ver 1.1.docx (en)	Authorised
Relpexa Selontra,	PT14	Italy	BASF Italia S.p.A	IT-0023576-0000	IT/2020/00659/MRP	28/04/2020	31/12/2026	Single SPC (it)	decreto proroga rodenticidi 2024.pdf (it) decreto MRP - Selontra.pdf (it) Lettera invio e decreto NA-MIC - Selontra -Relpexa - BC-YV075207-97.pdf (it) Lettera invio e decreto NA-ADC - Selontra - BC-NY089745-86.pdf (it)	Authorised
Exittus Relpexa Selontra	PT14	Latvia	BASF SIA	LV-0023574-0000	LV/2020/MR/006	01/07/2020	27/04/2025	Single SPC (lv)	BasfOy_Selontra_NA-MRP_EN.pdf (en) BasfOy_Selontra_NA-MRP_LV.pdf (lv)	Authorised
Exittus Relpexa Selontra	PT14	Lithuania	BASF UAB	LT-0023579-0000	(10-14 17.5 Mr)BPR-164(A-14PAP483793-21-95)	23/04/2021	27/04/2025	Single SPC (lt)	authorisation Selontra NA-MIC.pdf (lt) AL Selontra 2021 public.pdf (lt)	Authorised
Relpexa Selontra	PT14	Netherlands	BASF Nederland B.V.	NL-0023557-0000	-	28/04/2020	27/04/2025	Single SPC (nl)	20230210_NL-0023557-0000_Decision.pdf (nl) 20200703_NL-0023557-0000_Authorisation.pdf (nl) 20221212- BASF-amendment.pdf (nl)	Authorised
Exittus Relpexa Selontra	PT14	Norway	BASF AS	NO-0023559-0000	NO-2020-0192	28/04/2020	27/04/2025	Jazyk Single SPC (no) Single SPC (en)	NO-0023559-0000_MIC_21022023_decision.pdf (en)	Authorised
Selontra	PT14	Poland	BASF Polska Sp.z o.o.	PL-0023575-0000	PL/2021/0462/MR	27/01/2021	27/04/2025	Single SPC (pl)	PB.PL.2021.0462.MR.z1.101.2023 Selontra D.pdf (pl) PB.PL.2021.0462.MR Selontra MRP.pdf (pl)	Authorised
Relpexa Selontra	PT14	Portugal	BASF Portuguesa S.A.	PT-0028403-0000	PT/DGS mrs-135/2022 and PT/DGS mrs-136/2022	21/03/2022	27/04/2025	Single SPC (pt)	mrs 136-2022_Relpexa_P_BASF.pdf (pt) mrs 135-2022_Selontra_P_BASF.pdf (pt)	Authorised
Relpexa Selontra	PT14	Romania	BASF S.R.L.	RO-0023578-0000	RO/2020/283/MRP/ FI-2020-0009	28/04/2020	27/04/2025	Single SPC (ro)	Authorization certificate from MSCA-Romana for Selontra Relpexa from BASF SRL.pdf (ro)	Authorised
Relpexa Selontra	PT14	Slovakia	BASF Slovensko s r.o.	SK-0023572-0000	SK20-017	24/07/2020	27/04/2025	Single SPC (sk)	NA-MRP_authorisation_Selontra.pdf (sk) NA-MIC supplement No 1_Selontra.pdf (sk)	Authorised
Relpexa Selontra	PT14	Slovenia	BASF Slovenija d.o.o.	SI-0023564-0000	SI-0023564-0000	14/05/2020	27/04/2025	Single SPC (sl)	BASF_Slovenija_Selontra_MIC_SI-0023564.pdf (sl) BASF__Selontra__SI-0023564_MRS_P.pdf (sl)	Authorised
RELPEXA Selontra	PT14	Spain	BASF Espanola S.L.	ES-0023571-0000	ES/MR(NA)-2020-14-00711	25/06/2020	27/04/2025	Single SPC (es)	R4BP_ES-0023571-0000_Authorisation.pdf (es) R4BP_ES-0023571-0000_Authorisation.pdf (es) R4BP3-ES-0023571-0000-Authorisation.pdf (es)	Authorised
Exittus Relpexa Selontra	PT14	Sweden	BASF AB	SE-0023563-0000	5613	28/04/2020	27/04/2025	Single SPC (sv)	5613_Beslut_2020-05-20.pdf (sv) 5613_Beslut_2023-02-09.pdf (sv) 5613_Beslut_2023-02-09.pdf (sv)	Authorised
Selontra, Relpexa	PT14	Switzerland	BASF SE	CH-0023570-0000	CH-2020-0008	30/04/2020	27/04/2025	Single SPC (de)		Authorised
Relpexa Selontra	PT14	United Kingdom	BASF plc	UK-0023569-0000	UK-2020-1257	28/04/2020	31/12/2020	SPC not available		Expired

Reference authorisation

Trade name: Exittus , Relpexa , Selontra
Authorisation number: FI-0023556-0000| Market area: Finland

4 assessment records available

National authorisation minor change on request

Evaluating authority:

Finland

Conclusion date:

30/01/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Jazyk

Single SPC (fi)

Amendment of national authorisation

Evaluating authority:

Finland

Conclusion date:

30/10/2020

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Finland

Conclusion date:

30/04/2020

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Application of national authorisation

Evaluating authority:

Finland

Conclusion date:

29/04/2020

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition

Trade name: Relpexa , Selontra
Authorisation number: AT-0023568-0000| Market area: Austria

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Austria

Conclusion date:

17/01/2024

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (de)

National authorisation minor change on request

Evaluating authority:

Austria

Conclusion date:

21/12/2023

Validity of authorisation

Start date:

20/11/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Austria

Conclusion date:

03/03/2021

Validity of authorisation

Start date:

20/11/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: BE-0024691-0000| Market area: Belgium

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Belgium

Conclusion date:

03/02/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Jazyk

Single SPC (nl)

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

26/01/2021

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in sequence

Evaluating authority:

Belgium

Conclusion date:

18/01/2021

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: BG-0023577-0000| Market area: Bulgaria

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Bulgaria

Conclusion date:

14/08/2020

Validity of authorisation

Start date:

05/06/2020

End date:

27/04/2025

SPC

Jazyk

Single SPC (bg)

Trade name: Relpexa , Selontra
Authorisation number: HR-0023573-0000| Market area: Croatia

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Croatia

Conclusion date:

13/06/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (hr)

National authorisation minor change on request

Evaluating authority:

Croatia

Conclusion date:

01/06/2023

Validity of authorisation

Start date:

13/10/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Croatia

Conclusion date:

21/10/2020

Validity of authorisation

Start date:

13/10/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra,
Authorisation number: CY-0023566-0000| Market area: Cyprus

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Cyprus

Conclusion date:

15/06/2023

Validity of authorisation

Start date:

10/03/2021

End date:

27/04/2025

SPC

Single SPC (el)

Mutual recognition in parallel

Evaluating authority:

Cyprus

Conclusion date:

10/03/2021

Validity of authorisation

Start date:

10/03/2021

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: CZ-0023561-0000| Market area: Czech Republic

4 assessment records available

National authorisation administrative change on request

Evaluating authority:

Czech Republic

Conclusion date:

26/06/2024

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (cs)

Amendment of national authorisation

Evaluating authority:

Czech Republic

Conclusion date:

21/02/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

National authorisation minor change on request

Evaluating authority:

Czech Republic

Conclusion date:

21/02/2023

Validity of authorisation

Start date:

24/02/2021

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Czech Republic

Conclusion date:

25/02/2021

Validity of authorisation

Start date:

24/02/2021

End date:

27/04/2025

SPC

SPC not available

Trade name: Exittus , Relpexa , Selontra
Authorisation number: DK-0023560-0000| Market area: Denmark

4 assessment records available

Amendment of national authorisation

Evaluating authority:

Denmark

Conclusion date:

17/05/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (da)

National authorisation minor change on request

Evaluating authority:

Denmark

Conclusion date:

22/02/2023

Validity of authorisation

Start date:

01/05/2020

End date:

27/04/2025

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Denmark

Conclusion date:

18/05/2020

Validity of authorisation

Start date:

01/05/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Denmark

Conclusion date:

01/05/2020

Validity of authorisation

Start date:

01/05/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Exittus , Relpexa , Selontra,
Authorisation number: EE-0023565-0000| Market area: Estonia

3 assessment records available

Transfer of a national authorisation

Evaluating authority:

Estonia

Conclusion date:

26/01/2024

Validity of authorisation

Start date:

27/05/2020

End date:

27/04/2025

SPC

Single SPC (et)

National authorisation minor change on request

Evaluating authority:

Estonia

Conclusion date:

20/03/2023

Validity of authorisation

Start date:

27/05/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Estonia

Conclusion date:

02/06/2020

Validity of authorisation

Start date:

27/05/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: RELPEXA , SELONTRA
Authorisation number: FR-0023558-0000| Market area: France

4 assessment records available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

22/03/2023

Validity of authorisation

Start date:

19/06/2020

End date:

27/04/2025

SPC

Single SPC (fr)

National authorisation minor change on request

Evaluating authority:

France

Conclusion date:

21/03/2023

Validity of authorisation

Start date:

13/08/2020

End date:

27/04/2025

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

14/08/2020

Validity of authorisation

Start date:

13/08/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

France

Conclusion date:

19/06/2020

Validity of authorisation

Start date:

19/06/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: DE-0023567-0000| Market area: Germany

6 assessment records available

Amendment of national authorisation

Evaluating authority:

Germany

Conclusion date:

18/08/2023

Validity of authorisation

Start date:

11/05/2020

End date:

27/04/2025

SPC

Single SPC (de)

Amendment of national authorisation

Evaluating authority:

Germany

Conclusion date:

03/07/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Germany

Conclusion date:

26/04/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

National authorisation minor change on request

Evaluating authority:

Germany

Conclusion date:

14/02/2023

Validity of authorisation

Start date:

11/05/2020

End date:

27/04/2025

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Germany

Conclusion date:

21/08/2020

Validity of authorisation

Start date:

11/05/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Germany

Conclusion date:

11/05/2020

Validity of authorisation

Start date:

11/05/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra,
Authorisation number: GR-0023562-0000| Market area: Greece

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Greece

Conclusion date:

06/03/2023

Validity of authorisation

Start date:

19/06/2020

End date:

27/04/2025

SPC

Single SPC (el)

Amendment of national authorisation

Evaluating authority:

Greece

Conclusion date:

31/12/2020

Validity of authorisation

Start date:

19/06/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Greece

Conclusion date:

01/07/2020

Validity of authorisation

Start date:

19/06/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: REPLEXA rágcsálóirtó pép , SELONTRA rágcsálóirtó pép
Authorisation number: HU-0023580-0000| Market area: Hungary

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Hungary

Conclusion date:

08/02/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (hu)

Mutual recognition in parallel

Evaluating authority:

Hungary

Conclusion date:

15/10/2020

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Selontra, Relpexa
Authorisation number: IE-0023581-0000| Market area: Ireland

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Ireland

Conclusion date:

02/08/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (en)

Amendment of national authorisation

Evaluating authority:

Ireland

Conclusion date:

05/10/2020

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Ireland

Conclusion date:

15/07/2020

Validity of authorisation

Start date:

15/07/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra,
Authorisation number: IT-0023576-0000| Market area: Italy

4 assessment records available

Amendment of national authorisation

Evaluating authority:

Italy

Conclusion date:

15/05/2024

Validity of authorisation

Start date:

28/04/2020

End date:

31/12/2026

SPC

Single SPC (it)

National authorisation administrative change on request

Evaluating authority:

Italy

Conclusion date:

25/01/2024

Validity of authorisation

Start date:

08/07/2020

End date:

08/07/2025

SPC

SPC not available

National authorisation minor change on request

Evaluating authority:

Italy

Conclusion date:

23/05/2023

Validity of authorisation

Start date:

08/07/2020

End date:

08/07/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Italy

Conclusion date:

03/08/2020

Validity of authorisation

Start date:

08/07/2020

End date:

08/07/2025

SPC

SPC not available

Trade name: Exittus , Relpexa , Selontra
Authorisation number: LV-0023574-0000| Market area: Latvia

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Latvia

Conclusion date:

15/02/2023

Validity of authorisation

Start date:

01/07/2020

End date:

27/04/2025

SPC

Single SPC (lv)

Mutual recognition in parallel

Evaluating authority:

Latvia

Conclusion date:

01/07/2020

Validity of authorisation

Start date:

01/07/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Exittus , Relpexa , Selontra
Authorisation number: LT-0023579-0000| Market area: Lithuania

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Lithuania

Conclusion date:

21/05/2024

Validity of authorisation

Start date:

23/04/2021

End date:

27/04/2025

SPC

Single SPC (lt)

Mutual recognition in parallel

Evaluating authority:

Lithuania

Conclusion date:

23/04/2021

Validity of authorisation

Start date:

23/04/2021

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: NL-0023557-0000| Market area: Netherlands

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Netherlands

Conclusion date:

03/02/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (nl)

Amendment of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

12/12/2022

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Netherlands

Conclusion date:

29/06/2020

Validity of authorisation

Start date:

03/07/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Exittus , Relpexa , Selontra
Authorisation number: NO-0023559-0000| Market area: Norway

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Norway

Conclusion date:

21/02/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Jazyk

Single SPC (no)

Amendment of national authorisation

Evaluating authority:

Norway

Conclusion date:

26/04/2021

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Norway

Conclusion date:

04/09/2020

Validity of authorisation

Start date:

01/09/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Selontra
Authorisation number: PL-0023575-0000| Market area: Poland

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Poland

Conclusion date:

28/09/2023

Validity of authorisation

Start date:

27/01/2021

End date:

27/04/2025

SPC

Single SPC (pl)

Mutual recognition in parallel

Evaluating authority:

Poland

Conclusion date:

29/01/2021

Validity of authorisation

Start date:

27/01/2021

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: PT-0028403-0000| Market area: Portugal

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Portugal

Conclusion date:

21/03/2022

Validity of authorisation

Start date:

21/03/2022

End date:

27/04/2025

SPC

Single SPC (pt)

Trade name: Relpexa , Selontra
Authorisation number: RO-0023578-0000| Market area: Romania

2 assessment records available

Amendment of national authorisation

Evaluating authority:

Romania

Conclusion date:

18/02/2021

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (ro)

Mutual recognition in parallel

Evaluating authority:

Romania

Conclusion date:

18/02/2021

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: SK-0023572-0000| Market area: Slovakia

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Slovakia

Conclusion date:

11/04/2023

Validity of authorisation

Start date:

24/07/2020

End date:

27/04/2025

SPC

Single SPC (sk)

Mutual recognition in parallel

Evaluating authority:

Slovakia

Conclusion date:

24/07/2020

Validity of authorisation

Start date:

24/07/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: SI-0023564-0000| Market area: Slovenia

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Slovenia

Conclusion date:

20/02/2023

Validity of authorisation

Start date:

14/05/2020

End date:

27/04/2025

SPC

Single SPC (sl)

Mutual recognition in parallel

Evaluating authority:

Slovenia

Conclusion date:

14/05/2020

Validity of authorisation

Start date:

14/05/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: RELPEXA , Selontra
Authorisation number: ES-0023571-0000| Market area: Spain

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Spain

Conclusion date:

10/02/2023

Validity of authorisation

Start date:

25/06/2020

End date:

27/04/2025

SPC

Single SPC (es)

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

23/07/2020

Validity of authorisation

Start date:

25/06/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Spain

Conclusion date:

30/06/2020

Validity of authorisation

Start date:

25/06/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Exittus , Relpexa , Selontra
Authorisation number: SE-0023563-0000| Market area: Sweden

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Sweden

Conclusion date:

20/02/2023

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

Single SPC (sv)

National authorisation minor change on request

Evaluating authority:

Sweden

Conclusion date:

09/02/2023

Validity of authorisation

Start date:

20/05/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Sweden

Conclusion date:

20/05/2020

Validity of authorisation

Start date:

20/05/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Selontra, Relpexa
Authorisation number: CH-0023570-0000| Market area: Switzerland

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Switzerland

Conclusion date:

11/04/2023

Validity of authorisation

Start date:

30/04/2020

End date:

27/04/2025

SPC

Single SPC (de)

Mutual recognition in parallel

Evaluating authority:

Switzerland

Conclusion date:

30/04/2020

Validity of authorisation

Start date:

30/04/2020

End date:

27/04/2025

SPC

SPC not available

Trade name: Relpexa , Selontra
Authorisation number: UK-0023569-0000| Market area: United Kingdom

2 assessment records available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

16/10/2020

Validity of authorisation

Start date:

28/04/2020

End date:

27/04/2025

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

United Kingdom

Conclusion date:

15/10/2020

Validity of authorisation

Start date:

14/10/2020

End date:

27/04/2025

SPC

SPC not available