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Biocidal product factsheet - Last updated: 28/03/2024

Biocidal Product details

Trade name:

Vaprox® 59 Hydrogen Peroxide Sterilant

Product-type:

PT02

Active Substance details

Substance name:

Hydrogen peroxide

IUPAC name:

peroxol

EC number:

231-765-0

CAS number:

7722-84-1

BAS number:

1315

Authorised

Expired

Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

Amended_PAR_Vaprox_BPF_12042023.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
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Lithuania	STERIS Ireland Limited	R4BP 3 asset	National	LT-0020911-0002	(10-14 17.5)BSV-11997(A-02PAP1183347-19-229)	13/06/2019	14/04/2029	Family SPC (lt) Member SPC (lt)	Vaprox biocidal products family.pdf (lt)	Authorised
-	PT02	Netherlands	STERIS Ireland Limited	NL-0020016-0002	-	09/11/2023	14/04/2029	Family SPC (nl) Member SPC (nl)	20231109_nl_0020016_0000_administratieve_change.pdf (nl) 20170249_NL-0020016-0000 Authorisation.pdf (nl) 20230119_nl_0020016_0000_administratieve_change.pdf (nl)	Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Luxembourg	STERIS Ireland Limited	LU-0017907-0002	158/19/L-M00-000	16/07/2019	14/04/2029	Family SPC (fr) Member SPC (fr)	AMM_158_19_L-M00-000_Vaproxbiocidalproductfamily.pdf (fr) MOD_158_19_L-M00-000_Vaproxbiocidalproductfamily.pdf (fr)	Authorised
-	PT02	Malta	STERIS Ireland Limited	MT-0017934-0002	2019-07-16-B03	15/04/2019	14/04/2029	Family SPC (en) Member SPC (en)		Authorised
-	PT02	Bulgaria	STERIS Ireland Limited	BG-0025026-0002	2622-1	25/10/2019	14/04/2029	Family SPC (bg) Member SPC (bg)		Authorised
-	PT02	Sweden	STERIS Ireland Limited	SE-0020885-0002	5548	05/06/2019	14/04/2029	Family SPC (sv) Member SPC (sv)	5548_Beslut_2019-06-05.pdf (sv) 5548_Beslut_2023-01-12.pdf (sv)	Authorised
-	PT02	Greece	STERIS Ireland Limited	GR-0029490-0002	853,854/23-01-2023	23/01/2023	31/12/2033	Family SPC (el) Member SPC (el)		Authorised
-	PT02	Denmark	STERIS Ireland Limited	DK-0020827-0002	952-2	15/04/2019	14/04/2029	Family SPC (en) Member SPC (en)		Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Austria	STERIS Ireland Limited	AT-0021244-0002	AT-0021244-BPF	04/10/2019	04/10/2029	Family SPC (de) Member SPC (de)	Vaprox biocidal product family_Anlage 1.pdf (de) Erledigung_Bescheid_BMNT-UW.1.2.5_0567-V_5_2019_07.10.2019_.pdf (de) 2023-0.378.830_Aenderungsbescheid.pdf (de)	Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Belgium	STERIS Ireland Limited	BE-0017052-0002	BE2019-0031-00-00	15/04/2019	14/04/2029	Language Family SPC (fr) Member SPC (fr) Family SPC (de) Member SPC (de) Family SPC (nl) Member SPC (nl)	BE2019-0031-01-01_Act.pdf (fr) BE2019-0031-02-00_Act.pdf (fr) BE2019-0031-02-01_Act.pdf (fr) BE2019-0031-01-00_Act.pdf (fr) BE2019-0031-00-00_Act.pdf (fr)	Authorised
-	PT02	Switzerland	STERIS Ireland Limited	CH-0021205-0002	CH-2019-0011	22/07/2019	14/04/2029	Family SPC (de) Member SPC (de)		Authorised
-	PT02	Czech Republic	STERIS Ireland Limited	CZ-0021512-0002	CZ-0021512-0000	15/04/2019	14/04/2029	Family SPC (cs) Member SPC (cs)	podminky-povoleni_PUBLIC-Vaprox biocidal product family.pdf (cs)	Authorised
-	PT02	Germany	STERIS Ireland Limited	DE-0017070-0002	DE-0017070-00-0000-02	07/05/2019	14/04/2029	Family SPC (de) Member SPC (de)		Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Estonia	STERIS Ireland Limited	EE-0021926-0002	EE-0021926-0000	10/02/2020	14/04/2029	Family SPC (et) Member SPC (et)	NA-MRS luba Vaprox BPF 10-02-2020.pdf (et) NA-ADC luba Vaprox biocidal product family 23.02.2023.pdf (et)	Authorised
-	PT02	Spain	STERIS Ireland Limited	ES-0020821-0002	ES/MRF(NA)-2019-02-00622	15/04/2019	14/04/2029	Family SPC (es) Member SPC (es)	R4BP-ES-0020821-0000-Authorisation.pdf (es) R4BP3-ES-0020821-0000-v2.pdf (es) R4BP_ES-0020821-0000_Authorisation.pdf (es)	Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Finland	STERIS Ireland Limited	FI-0021179-0002	FI-2019-0008(family), FI-2019-0008-1, FI-2019-0008-2	15/04/2019	14/04/2029	Language Family SPC (fi) Member SPC (fi) Family SPC (en) Member SPC (en)	Vaprox_BPF_NA-ADC_12042023.pdf (fi) Vaprox_BPF_NA-MAC_24092020.pdf (fi) Vaprox_biocidal_product_family_17072019.pdf (fi)	Authorised
VAPROX® 59 HYDROGEN PEROXIDE STERILANT	PT02	France	STERIS Ireland Limited	FR-0016750-0002	FR-2019-0095	30/07/2019	14/04/2029	Family SPC (fr) Member SPC (fr)	VAPROXBIOCI_BC-RH028896-20_NA-MRP_D.pdf (fr) VAPROXBIOC_BC-MA082806-42_NA-ADC_D.pdf (fr)	Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Hungary	STERIS Ireland Limited	HU-0025203-0002	HU-2020-MA-02-00307-BF	15/04/2019	14/04/2029	Family SPC (hu) Member SPC (hu)	16141 01 2023 KBKHF Vaprox biocidal product family ADC Signed decision.pdf (hu) 22652 03 2020 KBKHF Vaprox BPF MRP.pdf (hu)	Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Ireland	STERIS Ireland Limited	IE-0020894-0002	IE/BPA 70686	08/07/2019	14/04/2029	Family SPC (en) Member SPC (en)	IE-BPA 70686 Authorisation Certificate.pdf (en)	Authorised
-	PT02	Italy	STERIS Ireland Limited	IT-0016971-0002	IT/2019/00578/MRP	11/09/2019	14/04/2029	Family SPC (it) Member SPC (it)	decreto mrp vaproxbiocidalproductfamily.pdf (it) Decreto BC-HD082810-52 Vaprox biocidal product family NA-ADC.pdf (it)	Authorised
-	PT02	Croatia	STERIS Ireland Limited	HR-0021774-0002	KLASA:UP/I-543-04/19-12/23	15/04/2019	13/06/2029	Family SPC (hr) Member SPC (hr)	rjesenje_Vaprox biocidal product family_HR.pdf (en)	Authorised
-	PT02	Latvia	STERIS Ireland Limited	LV-0021696-0002	LV/2020/MR/004	15/04/2019	14/04/2029	Family SPC (lv) Member SPC (lv)	SterisIrelandLimited_VaproxBiocidalProductFamily_NA-MRS_LV.pdf (lv) SterisIrelandLimited_VaproxBiocidalProductFamily_NA-MRS_EN.pdf (en)	Authorised
-	PT02	Norway	STERIS Ireland Limited	NO-0021697-0002	NO-2019-0179	15/04/2019	14/04/2029	Family SPC (no) Member SPC (no)	NO-0021697-0000_decision_080223_Vaprox biocidal product family.pdf (en) NO-0021697-0000_authorisation.pdf (en)	Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Poland	STERIS Ireland Limited	PL-0021197-0002	PL/2019/0404/MR/BPF	16/10/2019	14/04/2029	Family SPC (pl) Member SPC (pl)	PB.PL.2019.0404.MR.BPF.z1.75.2023 Vaprox Biocidal Product Family D.pdf (pl) PL.2019.0404.MR.BPF.pdf (pl)	Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Portugal	STERIS Ireland Limited	PT-0022102-0002	PT-DGS mrp18/2020 e PT-DGS mrp19/2020	14/01/2020	14/04/2029	Family SPC (pt) Member SPC (pt)	mrp19-2020_Vaprox 59 Hydrogen Peroxide Sterilant _Steris_dg.pdf (pt) mrp18-2020_Vaprox Hydrogen Peroxide Sterilant_Steris_dg.pdf (pt)	Authorised
-	PT02	Romania	STERIS Ireland Limited	RO-0028110-0002	RO/2021/0309/MRP/ UK-2019-1204	24/11/2021	14/04/2029	Family SPC (ro) Member SPC (ro)	Autorisation_Certificate nr. 309 VAPROX BIOCIDAL PRODUCT FAMILY - BC-QN063524-23 tp 02.docx (ro)	Authorised
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	United Kingdom	STERIS Ireland Limited	UK-0017015-0002	UK-2019-1204	15/04/2019	31/12/2020	SPC not available		Expired
Vaprox® 59 Hydrogen Peroxide Sterilant	PT02	Iceland	STERIS Ireland Limited	IS-0021037-0002	UST201905-105	18/07/2019	14/04/2029	Family SPC (en) Member SPC (en)	Authorisation for placing the biocidal product family Vaprox biocidal product family on the market in Iceland by mutual recognition.pdf (en)	Authorised

Reference authorisation

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: UK-0017015-0002| Market area: United Kingdom

1 assessment record available

Application of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

15/04/2019

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Mutual recognition

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: AT-0021244-0002| Market area: Austria

3 assessment records available

National authorisation administrative change on request

Evaluating authority:

Austria

Conclusion date:

22/05/2023

Validity of authorisation

Start date:

04/10/2019

End date:

04/10/2029

SPC

Family SPC (de)

Member SPC (de)

Amendment of national authorisation

Evaluating authority:

Austria

Conclusion date:

22/10/2019

Validity of authorisation

Start date:

04/10/2019

End date:

04/10/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Austria

Conclusion date:

11/09/2019

Validity of authorisation

Start date:

10/09/2019

End date:

10/09/2029

SPC

SPC not available

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: BE-0017052-0002| Market area: Belgium

4 assessment records available

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

03/10/2023

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Language

Family SPC (fr)

Member SPC (fr)

National authorisation administrative change on request

Evaluating authority:

Belgium

Conclusion date:

19/01/2023

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Belgium

Conclusion date:

12/07/2019

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Belgium

Conclusion date:

02/07/2019

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: BG-0025026-0002| Market area: Bulgaria

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Bulgaria

Conclusion date:

23/10/2020

Validity of authorisation

Start date:

25/10/2019

End date:

14/04/2029

SPC

Family SPC (bg)

Member SPC (bg)

Trade name: -
Authorisation number: HR-0021774-0002| Market area: Croatia

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Croatia

Conclusion date:

19/11/2019

Validity of authorisation

Start date:

15/04/2019

End date:

13/06/2029

SPC

Family SPC (hr)

Member SPC (hr)

Trade name: -
Authorisation number: CZ-0021512-0002| Market area: Czech Republic

3 assessment records available

National authorisation administrative change on request

Evaluating authority:

Czech Republic

Conclusion date:

07/02/2023

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Family SPC (cs)

Member SPC (cs)

Amendment of national authorisation

Evaluating authority:

Czech Republic

Conclusion date:

26/09/2019

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Czech Republic

Conclusion date:

26/09/2019

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: DK-0020827-0002| Market area: Denmark

5 assessment records available

National authorisation administrative change on request

Evaluating authority:

Denmark

Conclusion date:

07/07/2023

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Family SPC (en)

Member SPC (en)

Amendment of national authorisation

Evaluating authority:

Denmark

Conclusion date:

13/12/2021

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Denmark

Conclusion date:

16/11/2021

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Denmark

Conclusion date:

22/05/2019

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Denmark

Conclusion date:

22/05/2019

Validity of authorisation

Start date:

22/05/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: EE-0021926-0002| Market area: Estonia

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Estonia

Conclusion date:

23/02/2023

Validity of authorisation

Start date:

10/02/2020

End date:

14/04/2029

SPC

Family SPC (et)

Member SPC (et)

Mutual recognition in sequence

Evaluating authority:

Estonia

Conclusion date:

13/02/2020

Validity of authorisation

Start date:

10/02/2020

End date:

14/04/2029

SPC

SPC not available

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: FI-0021179-0002| Market area: Finland

4 assessment records available

Amendment of national authorisation

Evaluating authority:

Finland

Conclusion date:

27/03/2024

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Language

Family SPC (fi)

Member SPC (fi)

National authorisation administrative change on request

Evaluating authority:

Finland

Conclusion date:

12/04/2023

Validity of authorisation

Start date:

17/07/2019

End date:

14/04/2029

SPC

SPC not available

National authorisation major change on request

Evaluating authority:

Finland

Conclusion date:

24/09/2020

Validity of authorisation

Start date:

17/07/2019

End date:

14/04/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Finland

Conclusion date:

17/07/2019

Validity of authorisation

Start date:

17/07/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: VAPROX® 59 HYDROGEN PEROXIDE STERILANT
Authorisation number: FR-0016750-0002| Market area: France

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

France

Conclusion date:

20/03/2023

Validity of authorisation

Start date:

30/07/2019

End date:

14/04/2029

SPC

Family SPC (fr)

Member SPC (fr)

Mutual recognition in parallel

Evaluating authority:

France

Conclusion date:

01/08/2019

Validity of authorisation

Start date:

30/07/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: DE-0017070-0002| Market area: Germany

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Germany

Conclusion date:

03/01/2023

Validity of authorisation

Start date:

07/05/2019

End date:

14/04/2029

SPC

Family SPC (de)

Member SPC (de)

Mutual recognition in parallel

Evaluating authority:

Germany

Conclusion date:

07/05/2019

Validity of authorisation

Start date:

07/05/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: GR-0029490-0002| Market area: Greece

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Greece

Conclusion date:

22/02/2023

Validity of authorisation

Start date:

23/01/2023

End date:

31/12/2033

SPC

Family SPC (el)

Member SPC (el)

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: HU-0025203-0002| Market area: Hungary

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Hungary

Conclusion date:

03/05/2023

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Family SPC (hu)

Member SPC (hu)

Mutual recognition in parallel

Evaluating authority:

Hungary

Conclusion date:

19/11/2020

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: IS-0021037-0002| Market area: Iceland

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Iceland

Conclusion date:

22/08/2023

Validity of authorisation

Start date:

18/07/2019

End date:

14/04/2029

SPC

Family SPC (en)

Member SPC (en)

Mutual recognition in parallel

Evaluating authority:

Iceland

Conclusion date:

18/07/2019

Validity of authorisation

Start date:

18/07/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: IE-0020894-0002| Market area: Ireland

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Ireland

Conclusion date:

08/07/2019

Validity of authorisation

Start date:

08/07/2019

End date:

14/04/2029

SPC

Family SPC (en)

Member SPC (en)

Trade name: -
Authorisation number: IT-0016971-0002| Market area: Italy

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Italy

Conclusion date:

04/04/2023

Validity of authorisation

Start date:

11/09/2019

End date:

14/04/2029

SPC

Family SPC (it)

Member SPC (it)

Mutual recognition in parallel

Evaluating authority:

Italy

Conclusion date:

14/11/2019

Validity of authorisation

Start date:

11/09/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: LV-0021696-0002| Market area: Latvia

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Latvia

Conclusion date:

27/01/2023

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Family SPC (lv)

Member SPC (lv)

Mutual recognition in sequence

Evaluating authority:

Latvia

Conclusion date:

20/03/2020

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: LT-0020911-0002| Market area: Lithuania

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Lithuania

Conclusion date:

17/06/2019

Validity of authorisation

Start date:

13/06/2019

End date:

14/04/2029

SPC

Family SPC (lt)

Member SPC (lt)

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: LU-0017907-0002| Market area: Luxembourg

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Luxembourg

Conclusion date:

24/02/2023

Validity of authorisation

Start date:

16/07/2019

End date:

14/04/2029

SPC

Family SPC (fr)

Member SPC (fr)

Mutual recognition in parallel

Evaluating authority:

Luxembourg

Conclusion date:

24/07/2019

Validity of authorisation

Start date:

16/07/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: MT-0017934-0002| Market area: Malta

2 assessment records available

Amendment of national authorisation

Evaluating authority:

Malta

Conclusion date:

02/10/2019

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Family SPC (en)

Member SPC (en)

Mutual recognition in parallel

Evaluating authority:

Malta

Conclusion date:

23/07/2019

Validity of authorisation

Start date:

16/07/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: NL-0020016-0002| Market area: Netherlands

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

09/11/2023

Validity of authorisation

Start date:

09/11/2023

End date:

14/04/2029

SPC

Family SPC (nl)

Member SPC (nl)

National authorisation administrative change on request

Evaluating authority:

Netherlands

Conclusion date:

19/01/2023

Validity of authorisation

Start date:

02/08/2019

End date:

14/04/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Netherlands

Conclusion date:

25/07/2019

Validity of authorisation

Start date:

02/08/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: NO-0021697-0002| Market area: Norway

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Norway

Conclusion date:

08/02/2023

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Family SPC (no)

Member SPC (no)

Mutual recognition in sequence

Evaluating authority:

Norway

Conclusion date:

29/11/2019

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: PL-0021197-0002| Market area: Poland

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Poland

Conclusion date:

21/07/2023

Validity of authorisation

Start date:

16/10/2019

End date:

14/04/2029

SPC

Family SPC (pl)

Member SPC (pl)

Mutual recognition in parallel

Evaluating authority:

Poland

Conclusion date:

16/10/2019

Validity of authorisation

Start date:

16/10/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: Vaprox® 59 Hydrogen Peroxide Sterilant
Authorisation number: PT-0022102-0002| Market area: Portugal

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Portugal

Conclusion date:

14/01/2020

Validity of authorisation

Start date:

14/01/2020

End date:

14/04/2029

SPC

Family SPC (pt)

Member SPC (pt)

Trade name: -
Authorisation number: RO-0028110-0002| Market area: Romania

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Romania

Conclusion date:

16/02/2022

Validity of authorisation

Start date:

24/11/2021

End date:

14/04/2029

SPC

Family SPC (ro)

Member SPC (ro)

Trade name: -
Authorisation number: ES-0020821-0002| Market area: Spain

3 assessment records available

National authorisation administrative change on request

Evaluating authority:

Spain

Conclusion date:

23/03/2023

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

Family SPC (es)

Member SPC (es)

Amendment of national authorisation

Evaluating authority:

Spain

Conclusion date:

13/11/2020

Validity of authorisation

Start date:

15/04/2019

End date:

14/04/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Spain

Conclusion date:

10/07/2019

Validity of authorisation

Start date:

21/06/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: SE-0020885-0002| Market area: Sweden

2 assessment records available

National authorisation administrative change on request

Evaluating authority:

Sweden

Conclusion date:

12/01/2023

Validity of authorisation

Start date:

05/06/2019

End date:

14/04/2029

SPC

Family SPC (sv)

Member SPC (sv)

Mutual recognition in parallel

Evaluating authority:

Sweden

Conclusion date:

05/06/2019

Validity of authorisation

Start date:

05/06/2019

End date:

14/04/2029

SPC

SPC not available

Trade name: -
Authorisation number: CH-0021205-0002| Market area: Switzerland

3 assessment records available

National authorisation administrative change on request

Evaluating authority:

Switzerland

Conclusion date:

09/03/2023

Validity of authorisation

Start date:

22/07/2019

End date:

14/04/2029

SPC

Family SPC (de)

Member SPC (de)

Amendment of national authorisation

Evaluating authority:

Switzerland

Conclusion date:

16/09/2019

Validity of authorisation

Start date:

22/07/2019

End date:

14/04/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Switzerland

Conclusion date:

13/08/2019

Validity of authorisation

Start date:

22/07/2019

End date:

14/04/2029

SPC

SPC not available