Actifed

Maklumat utama

  • Nama dagangan:
  • Actifed Expectorant
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Actifed Expectorant
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL19860308
  • Kemaskini terakhir:
  • 31-08-2017

Risalah Maklumat Pesakit: ciri produk - komposisi, petunjuk, kesan sampingan, dos, interaksi, tindak balas buruk, kehamilan, penyusuan

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

ACTIFED

®

EXPECTORANT

Pseudoephedrine Hydrochloride/Triprolidine Hydrocholoride/Guaiphenesin (30mg/1.25mg/100mg per 5ml)

1

Apakah yang ada pada risalah

ini

Apakah kegunaan ACTIFED

EXPECTORANT

Bagaimana ACTIFED

EXPECTORANT berfungsi

Sebelum mengambil

ACTIFED EXPECTORANT

Cara menggunakan ACTIFED

EXPECTORANT

Semasa menggunakan

ACTIFED EXPECTORANT

Kesan-kesan sampingan

Cara penyimpanan dan

pelupusan ACTIFED

EXPECTORANT

Maklumat Lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan ACTIFED

EXPECTORANT

Actifed Expectorant adalah

digunakan untuk melegakan

gejala gangguan saluran

pernafasan bahagian atas yang

diiringi oleh batuk yang

produktif, yang bermanfaat

daripada pengambilan agen

nyah-sumbat hidung, sejenis

histamine H1-receptor

antagonist dan juga satu

kombinasi ekspektoran.

Bagaimana ACTIFED

EXPECTORANT berfungsi

Cecair ini mengandungi

pseudoephedrine hydrochloride,

iaitu suatu agen nyah-sumbat

yang meredakan hidung

tersumbat, triprolidine

hydrochloride adalah sejenis

antihistamine yang membantu

menghentikan bersin, hidung

berair dan mata berair dan

guaifenesin, adalah sejenis

ekspektoran yang membantu

mencairkan mucus di dalam

kerongkong dan dada anda.

Sebelum mengambil

ACTIFED EXPECTORANT

Bila tidak boleh mengambil

Jangan gunakan jika:

Anda alah kepada

pseudoephedrine, triprolidine,

guaiphesin atau mana-mana

bahan yang lain.

Anda mempunyai masalah

buah pinggang yang serius,

melainkan doktor anda

mengarahkan untuk

mengambil ubat ini.

Anda mempunyai tekanan

darah tinggi yang serius atau

penyakit jantung.

Anda mengambil sebarang

ubat-ubatan lain untuk

melegakan batuk, selsema,

kesesakan hidung atau hidung

tersumbat

Anda mengambil

antihistamine.

Anda mengambil mana-mana

ubat penekan atau perangsang

selera makan yang dipanggil

amphetamines (contoh:

kadang-kadang digunakan

untuk merawat gangguan

defisit perhatian).

Anda sedang mengambil atau

telah mengambil dalam masa

dua minggu, ubat

yang dipanggil perencat

monoamine oxidase (MAOI's).

Jika mana-mana di atas adalah

berkait dengan anda, dapatkan

nasihat daripada doktor atau ahli

farmasi sebelum mengambil

Actifed Expectorant.

Sebelum mengambilACTIFED

EXPECTORANT

Semak dengan doktor anda

sebelum menggunakan jika:

Anda mempunyai kelenjar

tiroid yang terlalu aktif,

sawan, pembesaran kelenjar

prostat, denyutan jantung

tidak teratur, glaukoma

(tekanan berlebihan di dalam

mata anda), kencing manis,

asma, kerosakan buah

pinggang yang sederhana,

radang paru-paru atau

phaeochromocytoma (tumor

kelenjar adrenal).

Anda mempunyai masalah

hati yang serius.

Anda mengambil ubat-ubatan

untuk mengawal tekanan

darah anda sebagai contoh,

ubat yang dipanggil beta

blocker.

Anda hamil atau menyusukan

bayi.

Anda mempunyai suatu jenis

masalah intolerans gula secara

keturunan yang jarang

berlaku.

Setiap 5ml sudu penuh ubat ini

mengandungi 0.35ml alkohol

(etanol). Jika anda mengalami

ketagihan arak, epilepsi (sawan)

atau penyakit hati, sila

berbincang dengan doktor anda

sebelum mengambil ubat ini.

Jika mengambil ubat-ubat lain

Berbincang dengan doktor atau

ahli farmasi anda jika anda

mengambil sebarang ubat-ubatan

lain, termasuk:

Sedative (Ubat yang

digunakan untuk merawat

keresahan dan tekanan).

Antihypertensives (Ubat yang

digunakan untuk merawat

tekanan darah tinggi

seperti guanethidine, methyldop

a, beta blocker, debrisoquine

dan betanidine).

Ubat Sympathomimetic

(Ubat perangsang atau penekan

selera makan dan ubat yang

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

2

digunakan untuk

merawat kesesakan hidung dan

asma).

Jika anda tidak pasti tentang

mana-mana ubat yang anda

ambil, tunjukkan botol atau pek

ubat tersebut kepada ahli farmasi

anda.

Cara menggunakan ACTIFED

EXPECTORANT

Berapa banyak harus

digunakan

Dewasa dan kanak-kanak

berumur 12 tahun dan ke atas:

Dos biasa: 10 ml diambil

setiap 4-6 jam seperti yang

diperlukan

Dos harian maksimum: 40 ml

dalam masa 24 jam

Kanak-kanak berumur 6 hingga

11 tahun:

Dos biasa: 5 ml diambil setiap

4-6 jam seperti yang

diperlukan

Dos harian maksimum: 20 ml

dalam masa 24 jam

Kanak-kanak berumur 2 hingga

5 tahun:

Dos yang biasa: 2.5 ml

diambil setiap 4-6 jam seperti

yang diperlukan

Dos harian maksimum: 10 ml

dalam masa 24 jam

Bila perlu digunakan

Gunakan seperti yang diarahkan

oleh doktor atau ahli farmasi

anda.

Berapa lama perlu digunakan

Perlu diambil setiap 4-6 jam,

seperti yang diperlukan.

Teruskan mengambil Actifed

Expectorant selama yang

disyorkan oleh doktor anda.

Jika terlupa menggunakan

Jika anda terlupa untuk

mengambil satu dos, ambil dos

seterusnya apabila

diperlukan, Jangan ambil dos

berganda.

Jika mengambil berlebihan

(terlebih dos)

Jika anda mengambil ubat ini

terlalu banyak, segera dapatkan

nasihat perubatan.

Pseudoephedrine yang

berlebihan boleh menyebabkan

simptom-simptom yang

disebabkan oleh rangsangan

sistem saraf pusat dan

kardiovaskular (contohnya

keterujaan, keresahan,

halusinasi, tekanan darah tinggi

dan degupan jantung tidak

seragam. Dalam kes-kes yang

teruk, psikosis, sawan, koma dan

peningkatan tekanan darah yang

sangat tinggi mungkin berlaku.

Kandungan kalium yang rendah

dalam darah mungkin berlaku.

Tripolidine yang berlebihan

berkemungkinan untuk

menyebabkan kesan yang sama

seperti yang disenaraikan di

dalam kesan-kesan sampingan.

Simptom-simptom lain termasuk

hilang kawalan pergerakan ,

kelemahan, masalah pernafasan,

kekeringan kulit dan membran

mukus, demam panas yang

sangat tinggi, geletar, psikosis,

sawan, kadar degupan jantung

yang terlalu laju dan degupan

jantung tidak seragam.

Guaiphenesin yang berlebihan

mungkin menyebabkan loya dan

muntah.

Semasa menggunakan

ACTIFED EXPECTORANT

Perkara yang perlu dilakukan

Semak dengan doktor atau ahli

farmasi sebelum mengambil

ubat anda dan ambil seperti yang

ditetapkan oleh doktor anda.

Perkara yang tidak boleh

dilakukan

Ubat ini telah ditetapkan untuk

anda. Jangan serahkan kepada

orang lain. Ia mungkin

memudaratkan mereka,

walaupun simptom mereka sama

seperti anda.

Jangan minum minuman

beralkohol semasa menggunakan

ubat ini.

Perkara yang perlu diberi

perhatian

Bukan untuk digunakan pada

kanak-kanak berumur kurang

daripada 2 tahun. Untuk

digunakan dengan berhati-hati

atas nasihat doktor / ahli farmasi

bagi kanak-kanak berumur 2-6

tahun.

Produk ini boleh menyebabkan

pening, mengantuk atau

penglihatan menjadi kabur.

Anda tidak seharusnya

memandu atau mengendalikan

jentera sehingga anda pasti anda

bahawa anda tidak terjejas.

Actifed Expectorant

mengandungi sukrosa. Ini perlu

diambil kira jika anda

mempunyai penyakit kencing

manis.

Actifed Expectorant tidak harus

digunakan untuk batuk

berterusan atau batuk kronik

seperti yang berlaku dengan

merokok, asma atau emfisema

(penyakit paru-paru yang

kronik) atau batuk yang disertai

dengan rembesan yang

berlebihan kecuali diarahkan

oleh doktor.

Actifed Expectorant

mengandungi methyl

parahydroxybenzoate dan bahan

pewarna yang boleh

menyebabkan reaksi alahan

(mungkin tindak balas lambat).

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

3

Jika anda tiba-tiba mengalami

sakit perut dan pendarahan dari

rektum, dapatkan nasihat doktor

and hentikan pengambilan

Actifed Expectorant.

Jika anda tiba-tiba mengalami

sakit kepala yang teruk, rasa

loya, muntah dan mengalami

gangguan penglihatan, dapatkan

nasihat doktor and hentikan

pengambilan Actifed

Expectorant.

Kesan-kesan sampingan

Seperti semua ubat-ubatan,

Actifed Expectorant boleh

menyebabkan kesan sampingan,

walaupun tidak semua orang

mendapatkannya. Jumpa ahli

farmasi anda dengan segera jika

anda mengalami sebarang kesan

sampingan selepas mengambil

ubat ini.

Apabila menggunakan produk

ini anda mungkin mengalami:

Rasa lali dan mengantuk

adalah simptom yang sangat

biasa

Gemuruh, sukar tidur, pening,

mulut, tekak atau hidung

kering, loya, muntah-muntah,

gangguan dalam perhatian dan

koordinasi tidak normal yang

mungkin biasa berlaku.

Halusinasi (mendengar suara

atau melihat sesuatu yang

tidak wujud, terutama pada

kanak-kanak) tetapi ini jarang

dilaporkan berlaku.

Kanak-kanak dan warga tua

adalah lebih cenderung untuk

mengalami kesan sampingan.

Berhenti menggunakan produk

ini dan berunding dengan doktor

anda jika anda mengalami:

Kesukaran untuk membuang

air. Ini adalah lebih cenderung

untuk berlaku jika anda

mempunyai pembesaran

kelenjar prostat.

Reaksi alahan: seperti ruam

kulit, gatal-gatal,

bengkak (kadang-kadang pada

muka, mulut dan tekak yang

menyebabkan kesukaran

bernafas) dan pitam. Reaksi-

reaksi ini adalah jarang

berlaku.

Anda boleh melaporkan

sebarang kesan sampingan atau

kesan advers ubat kepada Pusat

Pemantauan Kesan Advers Ubat

Kebangsaan melalui No. Tel:

03-78835550, atau laman web

portal.bpfk.gov.my (Consumers

Reporting)

Cara penyimpanan dan

pelupusan ACTIFED

EXPECTORANT

Penyimpanan

Jauhkan produk daripada

jangkauan dan penglihatan

kanak-kanak.

Simpan di bawah suhu 25 ° C

dan lindungi dari cahaya.

Jangan disejukkan.

Pelupusan

Ubat ini tidak boleh dilupuskan

melalui air sisa atau bahan

buangan isi rumah. Tanya ahli

farmasi bagaimana untuk

melupuskan ubat-ubatan yang

tidak diperlukan lagi. Langkah-

langkah ini akan membantu

untuk melindungi alam sekitar.

Maklumat lanjut

Rupa dan warna produk

Larutan oral yang jernih,

berwarna oren, dan berperisa

oren pedas.

Bahan-bahan kandungan

Bahan aktif

30 mg Pseudoephedrine

Hydrocholoride, 1.25 mg

Triprolidine Hydrocholoride,

dan 100 mg Guaiphenesin

terkandung dalam setiap 5 ml

Bahan tidak aktif

Sorbitol 70%, syrup, methyl

parahydroxybenzoate, sodium

benzoate, levomenthol, suset

yellow E110/FD&C Yellow No

6, Ethanol, Spicy Lemon

FC900853, purified water.

Nombor MAL

MAL19860308ACZ

Pengilang

Aspen Bad Oldesloe GMBH

Industriestrasse 32-36,

23843, Bad Oldesloe,

Germany

Pemegang Pendaftaran

Produk

GlaxoSmithKline

Pharmaceutical Sdn. Bhd.

Level 6, Quill 9,

112 Jalan Semangat,

46300 Petaling Jaya,

Selangor, Malaysia

Tarikh kemaskini RiMUP

- 26/04/2016

Nombor siri:

BPFK(R4/1)250416/00121

7-3-2019

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Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

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Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Europe - EMA - European Medicines Agency

29-1-2019


Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Europe - EMA - European Medicines Agency

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety