9 February 2017 EMA/110538/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack)

Procedure no.: PSUSA/00010442/201607

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, 2017. 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 Seasonique 150 microgrammes/30 microgrammes + 10 microgrammes, comprimé pelliculé Seasonique, filmomhulde tabletten Seasonique 0,15mg/0,03mg + 0,01 mg filmom obalené tablety Seasonique 150 Mikgrogramm/30 Mikrogramm + 10 Mikrogramm Filmtabletten Seasonique, (150 mikrogramów+30 mikrogramów) i 10 mikrogramów, tabletki powlekane Seasonique 150 microgrammes/30 microgrammes + 10 microgrammes, comprimé pelliculé Seasonique® 150 Mikrogramm/30 Mikrogramm + 10 Mikrogramm, Filmtabletten Seasonique 150/30 micrograme + 10 micrograme comprimate filmate

IS/H/0208/001

NL42237

TEVA SANTÉ

FR

FR/H/516/01

BE469475

BE

FR/H/516/01

17/0017/15-S

TEVA PHARMA BELGIUM N.V./S.A TEVA PHARMACEUTICALS SLOVAKIA S.R.O

FR/H/516/01

136021

RATIOPHARM ARZNEIMITTEL VERTRIEBS-GMBH

AT

FR/H/516/01

22353

TEVA PHARMACEUTICALS POLSKA SP. Z O.O.

PL

FR/H/516/01

NL42237

TEVA SANTÉ

FR

FR/H/516/01

87675.00.00

TEVA GMBH

DE

FR/H/516/01

7793/2015/01

TEVA PHARMACEUTICALS S.R.L

RO

SK

List of nationally authorised medicinal products EMA/110538/2017 Page 2/4

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 Seasonique 0,15 mg/0,03 mg + 0,01 mg filmom obložene tablete Seasonique comprimidos recubiertos con película Seasonique 150 micrograms/30 micrograms and 10 micrograms Film-coated Tablets Seasonique, filmomhulde tabletten Seasonique, 150 mikrogrammi / 30 mikrogrammi + 10 mikrogrammi õhukese polümeerikattega tabletid Seasonique 150 microgrammi / 30 microgrammi + 10 microgrammi , compresse rivestite con film Seasonique, comprimés pelliculés Seasonique, Filmtablette

FR/H/0516/001

HR-H-184612604

PLIVA HRVATSKA D.O.O.

HR

FR/H/0516/001

80340

TEVA PHARMA S.L.U

ES

FR/H/0516/001

PL 00289/1900

TEVA UK LIMITED

UK

FR/H/0516/001

RVG 117453

TEVA B.V

NL

FR/H/0516/001

894715

TEVA B.V

EE

FR/H/0516/001

042139016

TEVA ITALIA S.R.L.

IT

FR/H/0516/001

2016040084

LU

FR/H/0516/001

BE469475

Seasonique 150 mikrog/30 mikrog+ 10 mikrog tabletti, kalvopäällysteinen Seasonique, comprimés pelliculés

FR/H/0516/001

33439

TEVA PHARMA BELGIUM N.V./S.A TEVA PHARMA BELGIUM N.V./S.A TEVA B.V

FR/H/0516/001

BE469475

TEVA PHARMA BELGIUM N.V./S.A

BE

List of nationally authorised medicinal products EMA/110538/2017

BE FI

Page 3/4

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 Seasonique 150 mikrogramm/30 mikrogramm + 10 mikrogramm filmtabletta Seasonique 150 micrograms / + 30 micrograms 10 micrograms film-coated tablet Seasonique (0,03 mg + 0,15 mg) + (0,01 mg) comprimidos revestidos por película Seasonique 150 mikrog/30 mikrog + 10 mikrog filmdragerad tablett Seasonique 150 mikrogrami/30 mikrogrami + 10 mikrogrami apvalkotās tabletes Seasonique 150 mikrogramů/30 mikrogramů + 10 mikrogramů potahované tablety Seasonique Seasonique 0,15 mg/0,03 mg in 0,01 mg filmsko obložene tablete

FR/H/0516/001

OGYI-T-22930/01

TEVA GYÓGYSZERGYÁR ZRT

HU

FR/H/0516/001

53026

TEVA B.V

SE

FR/H/0516/001

5666854

TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

FR/H/0516/001

33439

TEVA B.V

FI

FR/H/0516/001

15-0334

TEVA B.V

LV

FR/H/0516/001

17/523/15-C

TEVA PHARMACEUTICALS CR, S.R.O.

CZ

FR/H/0516/001 FR/H/0516/001

56336 H/16/02191/001

TEVA PHARMA B.V. TEVA PHARMA B.V.

DK SI

List of nationally authorised medicinal products EMA/110538/2017

Page 4/4

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