27 October 2016 EMA/719205/2016 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: ethinylestradiol / gestodene (except for transdermal application)

Procedure no.: PSUSA/00001308/201603

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Alessia HEXAL 0,06 mg/ 0,015 mg Filmtabletten FR/H/0424/001 Arianna 60 microgrammi / 15 microgrammi compresse rivestite con film FR/H/0159/001 Arianna 60 microgrammi / 15 microgrammi compresse rivestite con film FR/H/0159/001 Arianna 60 microgrammi / 15 microgrammi compresse rivestite con film FR/H/0159/001 Etinilestradiol + Gestodeno Stallpharma 0,02 mg + 0,075 mg Comprimidos revestidos not available Etinilestradiol + Gestodeno Stallpharma 0,02 mg + 0,075 mg Comprimidos revestidos not available Etinilestradiol + Gestodeno Stallpharma 0,02 mg + 0,075 mg Comprimidos revestidos not available Fedra 0,075 mg + 0,02 mg compresse rivestite not available FEMODEN not available Femoden 0,03 mg/0,075 mg obložene tablete not available Femoden 0,03mg/0,075 mg obalené tablety not available Femoden 75/30 mikrogrammi kaetud tabletid not available Femoden 75/30 mikrogramu apvalkotās tabletes not available List of nationally authorised medicinal products EMA/719205/2016

78488.00.00

HEXAL AG

DE

034921015

BAYER SPA

IT

034921039

BAYER SPA

IT

034921027

BAYER SPA

IT

5628631

STALLPHARMA, PRODUTOS FARMACÊUTICOS LDA.

PT

5628649

STALLPHARMA, PRODUTOS FARMACÊUTICOS LDA.

PT

5628656

STALLPHARMA, PRODUTOS FARMACÊUTICOS LDA.

PT

029551013 56/220/93-C

BAYER SPA BAYER PHARMA AG

IT CZ

5363-I-2183/12

BAYER PHARMA AG

SI

17/140/94-S

BAYER PHARMA AG

SK

206298

BAYER PHARMA AG

EE

97-0161

BAYER PHARMA AG

LV

Page 2/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Femoden 75/30 mikrogramų dengtos tabletės not available Femoden bevont tabletta not available Femoden bevont tabletta not available Femoden dragerade tabletter not available Femoden päällystetyt tabletit not available Femoden, 0,075 mg + 0,03 mg, tabletki powlekane not available Femodene ® not available Femodene 0,075 / 0,030 mg, comprimés enrobés not available Femodene 0,075 / 0,030 mg, comprimés enrobés not available Femodene 0,075 / 0,030 mg, omhulde tabletten not available Femodene 0,075 / 0,030 mg, überzogene Tabletten not available Femodene 0,075 / 0,030 mg, überzogene Tabletten not available FEMODENE® ED not available Femodette ® not available Femovan® 0,03mg / 0,075mg überzogene Tabletten not available Gestoden/Etinilestradiol Sandoz 75 micrograme/30 micrograme comprimate NL/H/3352/002 Gestoden/Etinilestradiol Sandoz 75 micrograme/30 micrograme comprimate NL/H/3352/002 Gestoden/Etinilestradiol NL/H/3352/002

List of nationally authorised medicinal products EMA/719205/2016

LT/1/96/2476/001 OGYI-T-2360/02 OGYI-T-2360/01

BAYER PHARMA AG BAYER PHARMA AG BAYER PHARMA AG

LT HU HU

9970

BAYER OY

FI

9970

BAYER OY

FI

R/0601 PL 00010/0529

BAYER PHARMA AG BAYER PLC

PL UK

BE143622

BAYER SA NV

BE

1988050202

BAYER SA NV

LU

BE143622

BAYER SA NV

BE

BE143622

BAYER SA NV

BE

1988050202 PL 00010/0530 PL 00010/0531

BAYER SA NV BAYER PLC BAYER PLC

LU UK UK

6138.00.00

JENAPHARM GMBH & CO KG

DE

8714/2016/01

S.C. SANDOZ S.R.L.

RO

8714/2016/02 8714/2016/03

S.C. SANDOZ S.R.L. S.C. SANDOZ S.R.L.

RO RO

Page 3/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Sandoz 75 micrograme/30 micrograme comprimate GINODEN 0,075 mg + 0,03 mg compresse rivestite not Gynera, 0,03 mg + 0,075 mg, comprimido revestido not Gynera, 0,03 mg + 0,075 mg, comprimido revestido not Gynovin - Dragees not Gynovin 0,075 mg / 0,03 mg comprimidos recubiertos not Harmonet not Harmonet 0,02 mg + 0,075 mg comprimido revestido not Harmonet 0,02 mg + 0,075 mg comprimido revestido not Harmonet 0,02 mg + 0,075 mg comprimido revestido not Harmonet 0,02 mg + 0,075 mg comprimido revestido not HARMONET 0,075 mg + 0,02 mg compresse rivestite not Harmonet 0,075 mg/0,020 mg comprimés enrobés not Harmonet 0,075 mg/0,020 mg drajeuri (gestoden/etinilestradiol) not Harmonet 0,075 mg/0,020 mg drajeuri (gestoden/etinilestradiol) not Harmonet 0,075 mg/0,020 mg drajeuri (gestoden/etinilestradiol) not

available

026435038

BAYER SPA

IT

available

8689117

BAYER PORTUGAL LDA

PT

available available

8689109 1-18412

BAYER PORTUGAL LDA BAYER AUSTRIA GMBH

PT AT

available available

59.044 950056 (IS)

BAYER HISPANIA SL PFIZER APS

ES IS

available

2493781

LABORATÓRIOS PFIZER, LDA. PT

available

5131909

LABORATÓRIOS PFIZER, LDA. PT

available

5131917

LABORATÓRIOS PFIZER, LDA. PT

available

2493682

LABORATÓRIOS PFIZER, LDA. PT

available

030758015

PFIZER ITALIA S.R.L.

IT

available

BE174115

PFIZER S.A. (BELGIUM)

BE

available

3697/2011/04

PFIZER EUROPE MA EEIG

RO

available

3697/2011/03

PFIZER EUROPE MA EEIG

RO

available

3697/2011/01

PFIZER EUROPE MA EEIG

RO

List of nationally authorised medicinal products EMA/719205/2016

Page 4/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Harmonet 0,075 mg/0,020 mg drajeuri (gestoden/etinilestradiol) not Harmonet 0,075 mg/0,020 mg omhulde tabletten not Harmonet 0,075 mg/0,020 mg Überzogene Tabletten not Harmonet 75 mikrogramai / 20 mikrogramų dengtos tabletės not Harmonet 75 mikrogramai / 20 mikrogramų dengtos tabletės not Harmonet 75 mikrogrami/20 mikrogrami apvalkotās tabletes not Harmonet 75 mikrogramm/20 mikrogramm bevont tabletta not Harmonet 75 mikrogramm/20 mikrogramm bevont tabletta not Harmonet 75 mikrogramov/20 mikrogramov obložene tablete not HARMONET 75/20 microgramos comprimidos recubiertos not Harmonet 75/20 mikrogrammi kaetud tabletid not Harmonet tablett, dragerad not

available

3697/2011/02

PFIZER EUROPE MA EEIG

RO

available

BE174115

PFIZER S.A. (BELGIUM)

BE

available

BE174115

PFIZER S.A. (BELGIUM)

BE

available

LT/1/98/0362/002

PFIZER EUROPE MA EEIG

LT

available

LT/1/98/0362/001

PFIZER EUROPE MA EEIG

LT

available

98-0658

PFIZER EUROPE MA EEIG

LV

available

OGYI-T-6969/01

PFIZER KFT.

HU

available

OGYI-T-6969/02

PFIZER KFT.

HU

available

5363-I-718/13

PFIZER EUROPE MA EEIG

SI

available

61.975

WYETH FARMA, S.A

ES

available available

256799 12110

PFIZER EUROPE MA EEIG PFIZER OY

EE FI

List of nationally authorised medicinal products EMA/719205/2016

Page 5/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Harmonet tabletti, päällystetty not available HARMONET obalené tablety not available Harmonet, 75 mikrogramów (μg) + 20 mikrogramów (μg), tabletki drażowane not available HARMONET, comprimé enrobé not available HARMONET, comprimé enrobé not available Harmonet, overtrukne tabletter not available Harmonette – Dragees 75 Mikrogramm/ 20 Mikrogramm überzogene Tabletten not available Kosidina 0,075 mg/0,030 mg 21+7, tabletten NL/H/3352/002 Lenisagyn - 1 A Pharma FR/H/0425/001 Logest not available LOGEST 0,02 mg / 0,075 mg obložene tablete not available Logest 0,02 mg/0,075 mg obalené tablety not available Logest 0,02 mg/0,075 mg obložene tablete not available Logest 0,075 mg/0,02 mg, drajeuri not available Logest 75 mikrogramai / 20 mikrogramų dengtos tabletės not available Logest 75 mikrogramu/20 mikrogramu apvalkotās not available List of nationally authorised medicinal products EMA/719205/2016

12110

PFIZER OY

FI

17/058/99–C

PFIZER, SPOL. S R.O.

CZ

4871

PL

34009 339 220 7 8

PFIZER EUROPE MA EEIG PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.)

16935

PFIZER APS

DK

1–21827

PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.

AT

RVG 116281 78486.00.00 17/530/96-C

SANDOZ B.V. 1 A PHARMA GMBH BAYER PHARMA AG

NL DE CZ

UP/I-530-09/12-02/369

BAYER DOO

HR

17/0179/98-S

BAYER PHARMA AG

SK

H/00/00937/001

BAYER PHARMA AG

SI

6335/2014/01

BAYER PHARMA AG

RO

LT/1/97/2779/001

BAYER PHARMA AG

LT

98-0525

BAYER PHARMA AG

LV

34009 339 221 3 9

FR FR

Page 6/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number tabletes Logest, 0,075 mg + 0,02 mg, tabletki powlekane not available Logest, 75/20 mikrogrammi kaetud tabletid not available Lunafem not available Meliane - Dragees not available Meliane 0,020 mg/0,075 mg bevont tabletta not available Meliane 0,020 mg/0,075 mg bevont tabletta not available Meliane 0,075 / 0,020 mg, comprimés enrobés not available Meliane 0,075 / 0,020 mg, comprimés enrobés not available Meliane 0,075 / 0,020 mg, omhulde tabletten not available Meliane 0,075 / 0,020 mg, überzogene Tabletten not available Meliane 0,075 / 0,020 mg, überzogene Tabletten not available Meliane 0,075 mg / 0,02 mg comprimidos recubiertos not available Meliane Diario 0,075 mg/0,02 mg comprimidos recubiertos not available Meliane dragerade tabletter not available Meliane päällystetty tabletit not available MELIANE, comprimé enrobé not available MELIANE, comprimé enrobé not available MELODENE-15 0,06 mg/ 0,015 mg comprimidos FR/H/159/01

List of nationally authorised medicinal products EMA/719205/2016

4189

BAYER PHARMA AG

PL

248299 17/215/07-C 1-21825

BAYER PHARMA AG BAYER PHARMA AG BAYER AUSTRIA GMBH

EE CZ AT

OGYI-T-6814/01

BAYER PHARMA AG

HU

OGYI-T-6814/02

BAYER PHARMA AG

HU

BE174124

BAYER SA NV

BE

1995110340

BAYER SA NV

LU

BE174124

BAYER SA NV

BE

BE174124

BAYER SA NV

BE

1995110340

BAYER SA NV

LU

61.973

BAYER HISPANIA SL

ES

62.031 12108 12108 339 218.2 339 219.9

BAYER BAYER BAYER BAYER BAYER

HISPANIA SL OY OY HEALTHCARE HEALTHCARE

ES FI FI FR FR

63.176

BAYER HISPANIA SL

ES

Page 7/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number recubiertos con película MELODIA 60 microgrammes / 15 microgrammes, comprimé pelliculé FR/H/159/01 MELODIA 60 microgrammes / 15 microgrammes, comprimé pelliculé FR/H/159/01 MICROGESTE 60 microgramas/15 microgramas comprimido revestido por película FR/H/0159/001 MICROGESTE 60 microgramas/15 microgramas comprimido revestido por película FR/H/0159/001 Milvane compresse rivestite not available Milvane, 0,05 mg + 0,03 mg; 0,07 mg + 0,04 mg; 0,10 mg + 0,03 mg, tabletki powlekane not available MINESSE 0,06 mg/0,015 mg comprimidos recubiertos con película FR/H/0158/001 MINESSE 15 Mikrogramm/60 Mikrogramm Filmtabletten FR/H/0158/001 MINESSE 60 microgramas/15 microgramas comprimido revestido por película FR/H/0158/001 MINESSE 60 microgramas/15 microgramas comprimido FR/H/0158/001 List of nationally authorised medicinal products EMA/719205/2016

351 578-5

BAYER HEALTHCARE

FR

351 577-9

BAYER HEALTHCARE

FR

3245487

BAYER PORTUGAL LDA

PT

3245388 027358011

BAYER PORTUGAL LDA BAYER SPA

PT IT

4340

BAYER PHARMA AG

PL

63.239

ES

1-23620

WYETH FARMA, S.A PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.

3191087

LABORATÓRIOS PFIZER, LDA. PT

3191186

LABORATÓRIOS PFIZER, LDA. PT

AT

Page 8/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number revestido por película MINESSE 60 microgramas/15 microgramas comprimido revestido por película MINESSE 60 microgrammes/15 microgrammes, comprimé pelliculé MINESSE 60 microgrammes/15 microgrammes, comprimé pelliculé MINESSE 60 microgrammi/15 microgrammi compresse rivestite con film MINESSE 60 microgrammi/15 microgrammi compresse rivestite con film MINESSE 60 microgrammi/15 microgrammi compresse rivestite con film MINESSE 60 micrograms / 15 micrograms film-coated tablet MINESSE 60 micrograms / 15 micrograms film-coated tablet MINESSE potahované tablety Minigeste, 0,02 mg + 0,075 mg, comprimido

FR/H/0158/001

3750080

LABORATÓRIOS PFIZER, LDA. PT

FR/H/0158/001

34009 351 576 2 1

PFIZER HOLDING FRANCE (S.C.A.)

FR

FR/H/0158/001

34009 351 575 6 0

PFIZER HOLDING FRANCE (S.C.A.)

FR

FR/H/0158/001

034922017

PFIZER ITALIA S.R.L.

IT

FR/H/0158/001

034922031

PFIZER ITALIA S.R.L.

IT

FR/H/0158/001

034922029

PFIZER ITALIA S.R.L.

IT

FR/H/0158/001

PA 0822/144/001

PFIZER HEALTHCARE IRELAND IE

not available

MA505/06301

PFIZER HELLAS, A.E.

MT

not available

17/123/00-C

PFIZER, SPOL. S R.O.

CZ

not available

2494185

BAYER PORTUGAL LDA

PT

List of nationally authorised medicinal products EMA/719205/2016

Page 9/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number revestido Minigeste, 0,02 mg + 0,075 mg, comprimido revestido not Minulet - Dragees 75 Mikrogramm/ 30 Mikrogramm überzogene Tabletten not Minulet 0,03 mg + 0,075 mg comprimido revestido not Minulet 0,03 mg + 0,075 mg comprimido revestido not Minulet 0,03 mg + 0,075 mg comprimido revestido not MINULET 0,075 mg + 0,03mg compresse rivestite not Minulet 0,075 mg/0,030 mg comprimés enrobés not Minulet 0,075 mg/0,030 mg omhulde tabletten not Minulet 0,075 mg/0,030 mg Überzogene Tabletten not Minulet 75 micrograms/30 micrograms Coated Tablets not Minulet 75 mikrogramm/30 mikrogramm bevont tabletta not Minulet 75 mikrogramov/30 mikrogramov obložene tablete not MINULET 75/30 microgramos comprimidos recubiertos not MINULET obalené tablety not Minulet tablett, dragerad not

available

2494086

BAYER PORTUGAL LDA

PT

available

1-18411

PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.

AT

available

5131941

LABORATÓRIOS PFIZER, LDA. PT

available

8692004

LABORATÓRIOS PFIZER, LDA. PT

available

8692012

LABORATÓRIOS PFIZER, LDA. PT

available

026286029

PFIZER ITALIA S.R.L.

IT

available

BE142502

PFIZER S.A. (BELGIUM)

BE

available

BE142502

PFIZER S.A. (BELGIUM)

BE

available

BE142502

PFIZER S.A. (BELGIUM)

BE

available

PA 0822/093/001

PFIZER HEALTHCARE IRELAND IE

available

OGYI-T-2382/02

PFIZER KFT.

HU

available

5363-I-471/12

PFIZER EUROPE MA EEIG

SI

available available available

59.148 17/200/89–C 9971

WYETH FARMA, S.A PFIZER, SPOL. S R.O. PFIZER OY

ES CZ FI

List of nationally authorised medicinal products EMA/719205/2016

Page 10/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Minulet tabletti, päällystetty MINULET, comprimé enrobé MINULET, comprimé enrobé Minulet, dragees Minulet, overtrukne tabletter Mirelle 0,06 mg/0,015 mg filmom obalené tablety Mirelle 15 Mikrogramm/60 Mikrogramm – Filmtabletten Mirelle 60 / 15 mikrogramų plėvele dengtos tabletės Mirelle 60 microgram / 15 microgram, filmomhulde tablet Mirelle 60 microgrammes / 15 microgrammes , comprimé pelliculé Mirelle 60 microgrammes / 15 microgrammes , comprimé pelliculé MIRELLE 60 mikrogram/15 mikrogram, filmdragerade tabletter Mirelle 60 Mikrogramm/15 Mikrogramm, Filmtabletten Mirelle 60 Mikrogramm/15 Mikrogramm, Filmtabletten Mirelle 60/15 mikrogrammi õhukese polümeerikattega tabletid

not available

9971

FI

34009 330 512 5 9 RVG 12575

PFIZER OY PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER B.V.

not available

34009 330 513 1 0

not available not available not available

12921

PFIZER APS

DK

not available

17/0322/00-S

BAYER PHARMA AG

SK

FR/H/159/01

1-23621

BAYER AUSTRIA GMBH

AT

not available

LT/1/01/2826/001

BAYER PHARMA AG

LT

FR/H/159/01

BE212222

BAYER SA NV

BE

FR/H/159/01

BE212222

BAYER SA NV

BE

FR/H/159/01

2010049761

BAYER SA NV

LU

FR/H/159/01

15199

BAYER OY

FI

FR/H/159/01

BE212222

BAYER SA NV

BE

FR/H/159/01

2010049761

BAYER SA NV

LU

not available

377502

BAYER PHARMA AG

EE

List of nationally authorised medicinal products EMA/719205/2016

FR FR NL

Page 11/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Mirelle 60/15 mikrogramu apvalkotās tabletes not available Mirelle® 60 mikrog / 15 mikrog, kalvopäällysteiset tabletit FR/H/159/01 MONEVA, comprimé enrobé not available MONEVA, comprimé enrobé not available OPTINESSE 75 microgrammes/20 microgrammes, comprimé enrobé not available OPTINESSE 75 microgrammes/30 microgrammes, comprimé enrobé not available PHAEVA, comprimé enrobé not available PHAEVA, comprimé enrobé not available SYLVIANE, comprimé pelliculé not available SYLVIANE, comprimé pelliculé not available TRI MINULET, comprimé enrobé not available TRI MINULET, comprimé enrobé not available TRI MINULET, comprimé enrobé not available TRI MINULET, comprimé enrobé not available TRIADENE ® not available Tri-Femoden dragerade tabletter not available Tri-FemodenÒ päällystetyt tabletit not available

List of nationally authorised medicinal products EMA/719205/2016

02-0068

BAYER PHARMA AG

LV

15199 34009 330 511 9 8 34009 330 510 2 0

BAYER OY BAYER HEALTHCARE BAYER HEALTHCARE

FI FR FR

NL 42281

LABORATOIRES MAJORELLE

FR

NL 42282 34009 330 508 8 7 34009 330 509 4 8

LABORATOIRES MAJORELLE BAYER HEALTHCARE BAYER HEALTHCARE

FR FR FR

353 763-4

BAYER HEALTHCARE

FR

353 762-8

FR

34009 330 506 5 8 PL 00010/0563

BAYER HEALTHCARE PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) BAYER PLC

11177

BAYER OY

FI

11177

BAYER OY

FI

34009 330 507 1 9 34009 300 451 0 7 34009 300 451 1 4

FR FR FR FR UK

Page 12/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Tri-Gynera, (0,03 mg + 0,05 mg) + (0,04 mg + 0,07 mg) + (0,03 mg + 0,10 mg), comprimidos revestidos not Tri-Gynera, (0,03 mg + 0,05 mg) + (0,04 mg + 0,07 mg) + (0,03 mg + 0,10 mg), comprimidos revestidos not Trigynovin comprimidos recubiertos not Tri-Minulet (0,03 mg + 0,05 mg) + (0,04 mg + 0,07 mg) + (0,03 mg + 0,1 mg) comprimidos revestidos not Tri-Minulet (0,03 mg + 0,05 mg) + (0,04 mg + 0,07 mg) + (0,03 mg + 0,1 mg) comprimidos revestidos not Tri-Minulet Coated* Tablets not TRIMINULET compresse rivestite not Tri-Minulet comprimés enrobés not TRI-MINULET comprimidos recubiertos not Tri-Minulet omhulde tabletten not Tri-Minulet Überzogene Tabletten not Triodena - Dragees not Triodena bevont tabletta not

available

8770107

BAYER PORTUGAL LDA

PT

available

8770115

BAYER PORTUGAL LDA

PT

available

60.309

BAYER HISPANIA SL

ES

available

8773317

LABORATÓRIOS PFIZER, LDA. PT

available available

8773309 PA 822/099/001

LABORATÓRIOS PFIZER, LDA. PT PFIZER HEALTHCARE IRELAND IE

available

027359013

PFIZER ITALIA S.R.L.

IT

available

BE142511

PFIZER S.A. (BELGIUM)

BE

available

60.387

WYETH FARMA, S.A

ES

available

BE142511

PFIZER S.A. (BELGIUM)

BE

available available available

BE142511 1-18522 OGYI-T-5465/02

PFIZER S.A. (BELGIUM) BAYER AUSTRIA GMBH BAYER PHARMA AG

BE AT HU

List of nationally authorised medicinal products EMA/719205/2016

Page 13/14

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Triodena bevont tabletta Triodene, comprimés enrobés Triodene, comprimés enrobés Triodene, omhulde tabletten Triodene, überzogene Tabletten Triodene, überzogene Tabletten Yaluvea 0,06 mg / 0,015 mg Filmtabletten Логест 0,02 mg/0,075 mg обвити таблетки Фемоден 0,03 mg/0,075 mg обвити таблетки

not available

OGYI-T-5465/01

BAYER PHARMA AG

HU

not available

BE143631

BAYER SA NV

BE

not available

0442/88080360

BAYER SA NV

LU

not available

BE143631

BAYER SA NV

BE

not available

BE143631

BAYER SA NV

BE

not available

0442/88080360

BAYER SA NV

LU

NL/H/1901/001

80000.00.00

HORMOSAN PHARMA GMBH

DE

not available

9800303

BAYER PHARMA AG

BG

not available

20010359

BAYER PHARMA AG

BG

List of nationally authorised medicinal products EMA/719205/2016

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