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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:

IUPAC name:

peroxol

EC number:

231-765-0

CAS number:

7722-84-1

BAS number:

1315

Authorised
Expired
map
Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

28 authorisations in the product cluster
Authorisation number SPC Decisions

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

Family SPC  (fr)

Member SPC  (fr)

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

Bulgaria

STERIS Ireland Limited BG-0025026-0002 2622-1 25/10/2019 14/04/2029

Family SPC  (bg)

Member SPC  (bg)

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

-

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

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

Family SPC  (fi)

Member SPC  (fi)

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

-

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

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

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

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

-

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

Vaprox® 59 Hydrogen Peroxide Sterilant

PT02

Lithuania

STERIS Ireland Limited 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

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

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

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

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

-

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

-

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

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
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

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

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