31.5.2022

Official Journal of the European Union

C 215/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2022 to 30 April 2022

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2) )

(2022/C 215/01)

— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

1.4.2022

KIMMTRAK

tebentafusp

Immunocore Ireland Limited

Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, Ireland

EU/1/22/1630

Concentrate for solution for infusion

Pending

6.4.2022

4.4.2022

Breyanzi

lisocabtagene maraleucel

Bristol Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/22/1631

Dispersion for infusion

Pending

5.4.2022

7.4.2022

Bosulif

Bosutinib

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/13/818

Film-coated tablet

L01XE14

8.4.2022

13.4.2022

Padcev

enfortumab vedotin

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/21/1615

Powder for concentrate for solution for infusion

L01FX13

19.4.2022

25.4.2022

Inpremzia

insulin human (rDNA)

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/22/1644

Solution for infusion

A10AB01

27.4.2022

25.4.2022

Kapruvia

difelikefalin

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/22/1643

Solution for injection

V03AX04

27.4.2022

25.4.2022

PreHevbri

Hepatitis B vaccine (recombinant, adsorbed)

VBI Vaccines B.V.

Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland

EU/1/22/1641

Suspension for injection

J07BC01

27.4.2022

25.4.2022

Sitagliptin Accord

Sitagliptin

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/22/1633

Film-coated tablet

A10BH01

26.4.2022

25.4.2022

Truvelog Mix 30

insulin aspart

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/22/1639

Suspension for injection

A10AD05

26.4.2022

25.4.2022

Uplizna

inebilizumab

Viela Bio B.V.

Schiphol Boulevard 359, 1118 BJ Schiphol, Nederland

EU/1/21/1602

Concentrate for solution for infusion

L04AA

29.4.2022

25.4.2022

Vydura

rimegepant

Biohaven Pharmaceutical Ireland DAC

6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland

EU/1/22/1645

Oral lyophilisate

N02CD

26.4.2022

29.4.2022

Orgovyx

relugolix

Myovant Sciences Ireland Limited

Rocktwist House, Block 1 Western Business Park Shannon, Co. Clare V14 FW97, Ireland

EU/1/22/1642

Film-coated tablet

L02BX04

4.5.2022

29.4.2022

QUVIVIQ

daridorexant

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

EU/1/22/1638

Film-coated tablet

Pending

2.5.2022

— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.4.2022

Aclasta

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/05/308

5.4.2022

1.4.2022

Evista

SUBSTIPHARM

24 rue Erlanger, 75016 Paris, France

EU/1/98/073

20.4.2022

1.4.2022

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

5.4.2022

1.4.2022

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

6.4.2022

1.4.2022

OPDIVO

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1014

4.4.2022

1.4.2022

Replagal

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/01/189

5.4.2022

1.4.2022

Revatio

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/05/318

12.4.2022

1.4.2022

RotaTeq

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/348

4.4.2022

1.4.2022

Ultomiris

Alexion Europe SAS

103-105 Rue Anatole France, 92300 Levallois-Perret, France

EU/1/19/1371

5.4.2022

1.4.2022

Verzenios

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1307

4.4.2022

1.4.2022

YERVOY

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/11/698

4.4.2022

1.4.2022

Zostavax

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/341

4.4.2022

Axura

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/02/218

6.4.2022

4.4.2022

Bemrist Breezhaler

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/20/1441

5.4.2022

4.4.2022

Capecitabine Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/12/762

5.4.2022

4.4.2022

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

6.4.2022

4.4.2022

Elaprase

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/06/365

19.4.2022

4.4.2022

Erelzi

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

5.4.2022

4.4.2022

HBVAXPRO

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/01/183

6.4.2022

4.4.2022

Incresync

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/13/842

6.4.2022

4.4.2022

Kisqali

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/17/1221

5.4.2022

4.4.2022

Lorviqua

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/19/1355

6.4.2022

4.4.2022

Memantine Merz

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/12/799

11.4.2022

4.4.2022

MenQuadfi

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/20/1483

5.4.2022

4.4.2022

Ratiograstim

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/444

5.4.2022

4.4.2022

Reagila

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/17/1209

7.4.2022

4.4.2022

Shingrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

5.4.2022

4.4.2022

Tevagrastim

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/445

6.4.2022

4.4.2022

Vipdomet

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/13/843

6.4.2022

4.4.2022

Vipidia

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/13/844

6.4.2022

7.4.2022

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

7.4.2022

Pifeltro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1332

8.4.2022

12.4.2022

Veklury

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

22.4.2022

13.4.2022

ADCETRIS

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

21.4.2022

13.4.2022

Aldara

Meda AB

Pipers väg 2A, 170 73 Solna, Sverige

EU/1/98/080

21.4.2022

13.4.2022

Evkeeza

Ultragenyx Germany GmbH

Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland

EU/1/21/1551

20.4.2022

13.4.2022

Komboglyze

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/731

19.4.2022

13.4.2022

M-M-RVAXPRO

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/337

19.4.2022

13.4.2022

NeuroBloc

Sloan Pharma S.a.r.l.

33 Rue de Puits Romain, 8070 Bertrange, Luxembourg

EU/1/00/166

21.4.2022

13.4.2022

Onglyza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/545

19.4.2022

13.4.2022

ProQuad

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/323

19.4.2022

13.4.2022

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

19.4.2022

20.4.2022

Zolgensma

Novartis Gene Therapies EU Limited

Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland

EU/1/20/1443

21.4.2022

25.4.2022

Blitzima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1205

26.4.2022

25.4.2022

Byfavo

PAION Netherlands B.V.

Vogt 21, 6422 RK Heerlen, Nederland

EU/1/20/1505

27.4.2022

25.4.2022

Fampyra

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/11/699

28.4.2022

25.4.2022

Fycompa

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/12/776

26.4.2022

25.4.2022

Ilumetri

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/18/1323

2.5.2022

25.4.2022

Kevzara

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1196

26.4.2022

25.4.2022

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

28.4.2022

25.4.2022

Koselugo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1552

26.4.2022

25.4.2022

Kyntheum

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/16/1155

27.4.2022

25.4.2022

Lyumjev

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1422

28.4.2022

25.4.2022

MAVENCLAD

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1212

26.4.2022

25.4.2022

Nerlynx

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1311

26.4.2022

25.4.2022

OPDIVO

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1014

28.4.2022

25.4.2022

Sogroya

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1501

27.4.2022

25.4.2022

Starlix

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/01/174

29.4.2022

25.4.2022

Tecentriq

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/17/1220

26.4.2022

25.4.2022

Trumenba

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/17/1187

26.4.2022

25.4.2022

Vazkepa

Amarin Pharmaceuticals Ireland Limited

88 Harcourt Street, Dublin 2, D02DK18, Ireland

EU/1/20/1524

26.4.2022

25.4.2022

Xofluza

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/20/1500

26.4.2022

28.4.2022

Gardasil 9

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1007

29.4.2022

Azacitidine Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/19/1413

2.5.2022

29.4.2022

CABOMETYX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

2.5.2022

29.4.2022

Ecansya

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763

9.5.2022

29.4.2022

Gardasil

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/357

3.5.2022

29.4.2022

Gardasil 9

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1007

2.5.2022

29.4.2022

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

2.5.2022

29.4.2022

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

4.5.2022

29.4.2022

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

2.5.2022

29.4.2022

Jakavi

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/12/773

3.5.2022

29.4.2022

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/12/782

5.5.2022

29.4.2022

Mekinist

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/931

3.5.2022

29.4.2022

Nucala

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/15/1043

2.5.2022

29.4.2022

Ondexxya

Alexion Europe S.A.S.

103 Rue Anatole France, 92300 Levallois Perret, France

EU/1/18/1345

4.5.2022

29.4.2022

Poteligeo

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/18/1335

3.5.2022

29.4.2022

Seebri Breezhaler

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/12/788

3.5.2022

29.4.2022

Spherox

CO.DON AG

Warthestraße 21, 14513 Teltow, Deutschland

EU/1/17/1181

2.5.2022

29.4.2022

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Del Principe De Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

29.4.2022

Tovanor Breezhaler

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/12/790

3.5.2022

29.4.2022

Trevicta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/971

2.5.2022

29.4.2022

Vosevi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

3.5.2022

29.4.2022

Xevudy

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

29.4.2022

— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

13.4.2022

Pramipexole Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/11/728

19.4.2022

25.4.2022

Docetaxel Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/07/384

26.4.2022

29.4.2022

Starlix

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/01/174

3.5.2022

— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

19.4.2022

Chanaxin

tulathromycin

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/22/283

Solution for injection

Pending

21.4.2022

19.4.2022

RenuTend

tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/22/282

Suspension for injection

QM09AX90

22.4.2022

— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.4.2022

LETIFEND

LETI Pharma, S.L.U.

C/Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760 Madrid, España

EU/2/16/195

6.4.2022

CYTOPOINT

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/205

11.4.2022

6.4.2022

RESPIPORC FLUpan H1N1

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/209

7.4.2022

13.4.2022

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

20.4.2022

19.4.2022

SevoFlo

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/02/035

21.4.2022

26.4.2022

Credelio

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/206

28.4.2022

26.4.2022

CYTOPOINT

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/205

3.5.2022

26.4.2022

RESPIPORC FLUpan H1N1

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/209

2.5.2022

26.4.2022

Zulvac BTV

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/207

27.4.2022

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1) OJ L 136, 30.4.2004, p. 1.

(2) OJ L 4, 7.1.2019, p. 43.

31.5.2022

Official Journal of the European Union

C 215/12

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2022 to 30 April 2022

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) , Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3) )

(2022/C 215/02)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision	Name(s) of the medicinal product	INN (International Non-Proprietary Name)	Holder(s) of the marketing authorisation	Member State concerned	Date of notification
1.4.2022	Nasolam and associated names	midazolam	See Annex	See Annex	4.4.2022

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

(3) OJ L 4, 7.1.2019, p. 43.

ANNEX

List of medicinal products and presentations

Member State EU/EEA

Applicant

company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Denmark

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5 mg nasal spray, solution in single dose container (1)

2,5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Denmark

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75 mg nasal spray, solution in single dose container (1)

3,75 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Denmark

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Finland

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5 mg nasal spray, solution in single dose container (1)

2,5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Finland

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75 mg nasal spray, solution in single dose container

3,75 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Finland

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Germany

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5 mg, Nasenspray, Lösung im Einzeldosisbehältnis

2,5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Germany

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75 mg, Nasenspray, Lösung im Einzeldosisbehältnis

3,75 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Germany

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg, Nasenspray, Lösung im Einzeldosisbehältnis

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Ireland

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5 mg nasal spray, solution in single dose container

2,5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Ireland

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75 mg nasal spray, solution in single dose container

3,75 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Ireland

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

The Netherlands

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5 mg neusspray, oplossing in een verpakking voor éénmalig gebruik

2,5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

The Netherlands

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75 mg neusspray, oplossing in een verpakking voor éénmalig gebruik

3,75 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

The Netherlands

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg neusspray, oplossing in een verpakking voor éénmalig gebruik

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Norway

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 2,5 mg nasal spray, solution in single dose container (1)

2,5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Norway

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 3,75 mg nasal spray, solution in single dose container (1)

3,75 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Norway

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Sweden

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5 mg nasal spray, solution in single dose container (1)

2,5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Sweden

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75 mg nasal spray, solution in single dose container (1)

3,75 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Sweden

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

United Kingdom (Northern Ireland)

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5 mg nasal spray, solution in single dose container (1)

2,5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

United Kingdom (Northern Ireland)

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75 mg nasal spray, solution in single dose container

3,75 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

United Kingdom (Northern Ireland)

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

(1) Invented name not accepted by National Competent Authority, pending new proposal by the applicant

		ISSN 1977-091X
Official Journal of the European Union		C 215

English edition	Information and Notices	Volume 65 31 May 2022

Contents		page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2022/C 215/01	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2022 to 30 April 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)	1
2022/C 215/02	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2022 to 30 April 2022(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)	12