Amiohexal

Maklumat utama

  • Nama dagangan:
  • Amiohexal 200
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Amiohexal 200
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL20014330
  • 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)

AMIOHEXAL 200

Amiodarone hydrochloride (200mg)

Apakah yang ada pada risalah ini

Apakah kegunaan Amiohexal

Bagaimana Amiohexal berfungsi

Sebelum menggunakan Amiohexal

Cara menggunakan Amiohexal

Semasa menggunakan Amiohexal

Kesan-kesan sampingan

Cara penyimpaan dan pelupusan

Amiohexal

Maklumat lanjut

Pengilang dan Pemegang Pendaftaran

Produk

Tarikh kemaskini RiMUP

Apakan kegunaan Amiohexal

Amiohexal mengandungi bahan aktif yang

dikenali sebagai Amiodarone hydrochloride.

Amiohexal digunakan untuk mengawal

degupan jantung cepat atau tidak tetap.

Bagaimana Amiohexal berfungsi

Amiohexal adalah dari kumpulan ubat yang

dikenali sebagai ‘

antiarrhythmics

’. Ia

berfungsi dengan memanjangkan jarak

antara satu degupan jantung dengan satu

yang lain dan ini membantu kadar jantung

menjadi lebih lambat dan berdegup dengan

kadar lebih tetap.

Sebelum menggunakan Amiohexal

- Bila tidak boleh menggunakan

Anda tidak boleh mengambil Amiohexal

sekiranya anda:

Pernah mengalami alahan terhadap bahan

aktif amiodarone hydrochloride, atau kepada

bahan-bahan lain dalam Amiohexal

Pernah mengalami alahan terhadap iodine

Mempunyai penyakit kelenjar tiroid

Mengalami hipokalemia (tahap kalium

yang rendah dalam darah)

Mempunyai kadar denyutan jantung yang

sangat rendah (

sinus bradycardia

Mempunyai masalah jantung yang lain

terutamanya yang melibatkan pengawalan

degupan jantung. Jika anda menggunakan

perentak jantung (

pacemaker

), doktor anda

mungking akan membenarkan

pengambilannya.

Mengandung, atau beranggapan anda telah

mengandung atau sedang menyusu.

- Sebelum menggunakan Amiohexal

Beritahu doktor anda sekiranya anda

mengalami alahan terhadap ubat-ubatan lain,

makanan, bahan pengawet atau bahan

pewarna.

Beritahu doktor sekiranya anda:

Pernah mengalami kebengkakan pada

muka, bibir, lidah, kerongkong, tangan

atau kaki

Mempunyai sebarang masalah pernafasan

atau asma

Mempunyai penyakit hati

Mempunyai sebarang masalah kalenjar

tiroid

Mempunyai sebarang masalah penglihatan

Mempunyai tekanan darah rendah

Mempunyai sebarang masalah jantung

lain

Akan menjalani pembedahan

Beranggapan anda telah mengandung atau

mungkin telah mengandung atau sedang

menyusu

Pesakit tua

Bincang dengan doktor sekiranya anda tidak

pasti sama ada anda patut mengambil ubat

ini.

- Jika mengambil ubat-ubat lain

Maklumkan kepada doktor atau ahli farmasi

sekiranya anda sedang mengambil ubat lain,

termasuk ubatan yang didapatkan tanpa

preskripsi.

Sesetengah ubat boleh berinteraksi dengan

Amiohexal

.

Adalah penting untuk anda

memberitahu doktor atau ahli farmasi

sekiranya anda ada mengambil:

Sebarang ubat lain untuk jantung anda

Ubat untuk degupan jantung tidak tetap

arrhythmia

) contoh: quinidine and

procainamide

Sebarang ubat lain untuk merawat tekanan

darah tinggi, terutamanya beta-blockers

(atenolol, metoprolol) dan calcium channel-

blockers (nifedipine, verapamil)

Ubat untuk mencairkan darah contoh:

warfarin

Phenytoin (untuk rawatan sawan)

Digoxin, ubat untuk merawat masalah

jantung

Antibiotik contoh: fluoroquinolone

Ubat antidepresi contoh: doxepin,

maprotiline

Anti-psikotik (ubat digunakan untuk

merawat keadaan mental dan emosi) contoh:

chlorpromazine, thioridazine

Ubat untuk reaksi alahan

contoh: fenadine,

astemizole

Ubat untuk malaria contoh: quinine,

mefloquine

Diuretik (ubat untuk meningkatkan jumlah

air kencing)

dan amphotericin

(ubat antikulat) yang boleh menyebabkan

tahap rendah kalium dan magnesium di

dalam darah

Ubat pelali

Ubat untuk menekan aktiviti imunisasi

badan (contoh: ciclosporin)

Simvastatin atau ubat lain dari kumpulan

Statins (untuk mengurangkan paras

kolesterol)

Fentanyl (ubat digunakan untuk merawat

sakit), sildenafil (juga dikenali sebagai

Viagra), midazolam (ubat pelali), ergotamine

(untuk sakit kepala migrain), penggunaan

kombinasi boleh menyebabkan tosik ubat-

ubat tersebut.

Elakkan meminum jus anggur semasa

mengambil Amiohexal 200 tablet kerana ia

akan meningkatkan tahap amiodarone dalam

darah.

Senarai ini mungkin tidak lengkap bagi

semua interaksi yang mungkin berlaku.

Tanya doktor atau ahli farmasi anda jika

amiodarone hydrochloride boleh berinteraksi

dengan ubat-ubatan lain yang anda ambil.

- Semasa Mengandung dan Menyusu Bayi

Maklumkan kepada doktor sekiranya anda

mengandung, beranggapan anda telah

mengandung atau bercadang untuk

mengandung. Pengambilan amiodarone

semasa mengandung boleh membawa

bahaya kepada bayi. Amiohexal adalah tidak

disyorkan semasa mengandung.

Maklumkan kepada doktor sekiranya anda

sedang menyusu atau bercadang untuk

menyusu. Amiohexal 200 tidak disyorkan

untuk digunakan untuk ibu yang sedang

menyusu. Doktor anda mungkin akan pilih

rawatan yang lain sekiranya anda ingin

menyusu bayi anda.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Cara menggunakan Amiohexal

Sentiasa ambil

Amiohexal sepertimana yang

diarahkan oleh doktor atau ahli farmasi anda.

Tablet ini seharus diambil bersama dengan

kuantiti air yang mencukupi.

- Berapa banyak harus digunakan

Dos yang diberikan oleh doktor anda

mungkin berlainan dengan risalah ini.

Dewasa

Biasanya, dos permulaan adalah 200mg (1

tablet) diambil 3 kali sehari untuk 8 hingga

10 hari. Kemudiananya, doktor anda akan

mengurangkan dos anda perlahan-lahan,

bergantung kepada reaksi anda, kepada dos

pengekalan 200mg (1 tablet) sekali sehari.

Kanak-kanak dan Remaja

Tidak dibenarkan.

Warga tua

Perhatian perlu diambil. Sila dapatkan

nasihat doktor bagi dos yang perlu diambil.

- Bila perlu digunakan

Ambil Amiohexal pada masa yang sama

setiap hari.

- Berapa lama perlu digunakan

Teruskan pengambilan ubat ini selagi anda

diarahkan oleh doktor. Ubat ini bertujuan

untuk mengawal masalah kesihatan anda

tetapi bukan untuk menyembuhkannya.

Adalah penting untuk anda terus mengambil

ubat ini walaupun anda berasa sihat.

- Jika terlupa menggunakan

Ambil dos anda dengan segera apabila anda

ingat dan teruskan mengambil Amiohexal

seperti biasa. Jika hampir masa kepada dos

seterusnya, abaikan dos yang terlupa dan

ambil dos seterusnya pada waktu yang

ditetapkan. Jangan ambil dos berganda untuk

menggantikan dos yang anda terlupa.

- Jika mengambil berlebihan (terlebih dos)

Jika anda, atau sesiapa telah mengambil ubat

ini secara berlebihan, anda hendaklah segera

pergi ke Bahagian Rawatan Kecemasan

Hospital terdekat atau maklumkan kepada

doktor anda. Ini perlu dilakukan walaupun

tiada sebarang tanda ketidakselesaan atau

keracunan. Bawa bersama bungkusan atau

baki ubat yang selebihnya dengan anda.

Anda mungkin memerlukan perhatian

perubatan segera.

Semasa menggunakan Amiohexal

- Perkara yang perlu dilakukan

Sentiasa mengambil Amiohexal dengan

mengikut arahan yang diberikan oleh doktor

atau ahli farmasi anda. Dapatkan nasihat

doktor atau ahli farmasi anda sekiranya anda

tidak pasti.

Maklumkan kepada doktor atau ahli

farmasi anda jika anda sedang mengambil

ubat lain termasuk ubat yang diambil tanpa

preskripsi seperti suplemen atau ubat

tradisional.

Beritahu doktor atau ahli farmasi anda

dengan segera sekiranya anda perasan

sebarang kesan sampingan, kesan sampingan

menjadi serius atau apa-apa yang

menyebabkan anda berasa tidak sihat.

Sekiranya anda akan mula mengambil ubat

baru, ingatkan doktor dan ahli farmasi

bahawa anda sedang mengambil Amiohexal.

Sekiranya anda akan menjalani

pembedahan, ingatkan doktor dan ahli

farmasi anda bahawa anda sedang

mengambil Amiohexal.

Pastikan anda menghadiri semua temujanji

agar doktor anda boleh memastikan kesan

ubat terhadap anda.

- Perkara yang tidak boleh dilakukan

Jangan berhenti mengambil Amiohexal

tanpa kebenaran doktor anda

Jangan guna Amiohexal yang telah

melebihi tarikh luput yang dicetak pada

kotak dan strip ubat.

Jangan beri ubat ini kepada orang lain,

walaupun mereka mempunyai masalah

kesihatan yang sama dengan anda.

- Perkara yang perlu diberi perhatian

Pengambilan Amiohexal mungkin akan

menyebabkan kulit anda lebih sensistif

terhadap cahaya matahari dan lebih

senang menjadi gelap atau menyebabkan

kemerahan teruk dan bengkak. Selalu guna

krim pelindung cahaya (

sunscreen

) dan pakai

topi serta pakaian yang boleh melindungi

daripada cahaya semasa anda di luar.

Amiohexal boleh menyebabkan masalah

mata dan penglihatan kabur. Jangan

memandu atau mengendalikan jentera

sekiranya anda mengalami masalah tersebut.

Kesa-kesan sampingan

Semua ubat mempunyai kesan sampingan.

Amiohexal mungkin menyebabkan kesan

sampingan, tetapi, bukan setiap individu

akan mengalaminya.

Rawatan dengan amiodarone mungkin akan

menyebabkan masalah serius kepada paru-

paru, hati dan mata serta mungkin akan

memburukkan masalah jantung.

Beritahu doktor atau ahli farmasi anda

sekiranya anda perhatikan sebarang keadaan

berikut yang merisaukan anda:

Kalenjar tiroid terlampau aktif. Simptom

termasuk berat badan berkurang, gelisah,

tidak tahan panas, bergetar, berpeluh,

bengkak pada leher, kadar denyutan jantung

cepat

Kalenjar tiroid kurang aktif. Simptom

termasuk keletihan, lesu, kelemahan otot,

kejang, rasa sejuk, kadar denyutan jantung

perlahan, kulit kering dan menggelup

Kadar denyutan jantung yang perlahan

Loya, muntah dan perubahan dalam rasa

Sensitif kepada cahaya – menyebabkan

selaran matahari dan ruam kulit

Pigmentasi biru-kelabu pada kulit

Peningkatan enzim hati

Bergetar-getar, insomnia dan gangguan

tidur

Perasaan “jarum” atau kebas pada bahagian

tangan dan kaki

Kelemahan otot, pergerakan luar kawalan

atau koordinasi terjejas

Gangguan penglihatan

Senarai di atas merangkumi kesan-kesan

sampingan yang lebih umum untuk ubat ini.

Beritahu doktor anda segera sekiranya anda

perhatikan sebarang keadaan berikut:

Kesukaran untuk bernafas atau kesesakan

nafas

Degupan jantung tidak tetap bertambah

teruk

Jaundis (kekuningan kulit dan mata)

Kehilangan koordinasi yang mejejaskan

keseimbangan dan cara berjalan, anggota

badan, pergerakan mata dan pertuturan

Sakit dada, batuk dan meludah darah

Pening atau rasa pening

Pengurangan libido

Penglihatan kabur dan mata sensitif

terhadap cahaya

Keguguran rambut

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Masalah darah contoh: anemia

Senarai di atas merangkumi kesan-kesan

sampingan yang memerlukan perhatian

perubatan segera.

Sekiranya sebarang keadaan berikut berlaku,

beritahu doktor anda dengan segera atau

pergi ke hospital yang terdekat:

Reaksi alahan yang serius (ruam, gatal,

bengkak pada tangan, muka, bibir atau lidah)

Sebarang gangguan degupan jantung

seperti degupan jantung amat kuat, sangat

cepat atau terlalu perlahan atau degupan

berhenti

Kesukaran bernafas atau sesak nafas

Senarai di atas merangkumi kesan-kesan

sampingan yang sangat serius. Anda

memerlukan perhatian perubatan segera

atau jagaan hospital.

Maklumkan kepada doktor anda sekiranya

anda mendapati kesan-kesan sampingan lain

yang menyebabkan anda tidak sihat.

Sesetengah pesakit mungkin mengalami

kesan-kesan sampingan yang tidak

disenaraikan.

Doktor akan mengawasi kesan-kesan

sampingan anda secara teliti. Ini melibatkan

ujian darah untuk memeriksa sejauh mana

hati dan tiroid berfungsi. Pemeriksaan x-ray,

ECG dan ujian mata juga perlu dijalankan.

Doktor anda akan memberitahu anda berapa

kerap anda perlu menjalankan ujian ini. Ini

bergantung kepada dos dan tempoh terapi

anda.

Anda boleh melaporkan sebarang kesan

sampingan atau kesan advers ubat terus

kepada Pusat Pemantauan Kesan Advers

Ubat Kebangsaan melalui No. Tel: 03-

78835550, atau laman

web potal.bpfk.gov.my

Consumers

Reporting

Cara penyimpanan dan pelupusan

Amiohexal

- Penyimpanan

Jangan simpan pada suhu melebihi 30ºC.

Simpan dalam bungkusan asal untuk

melindungi daripada haba dan kelembapan.

Jangan simpan Amiohexal atau ubat-ubat

lain di dalam tandas, berdekatan dengan

sinki atau ditinggalkan di tepi tingkap atau di

dalam kereta.

Jauhi daripada kanak-kanak.

- Pelupusan

Tarikh luput Amiohexal dicetak pada kotak

dan papan ubat. Jangan guna sekiranya

melebihi tarikh luput.

Jika anda diarahkan oleh doktor untuk

berhenti mengambil Amiohexal, atau ia telah

melebihi tarikh luput, tanya ahli farmasi anda

bagaimana untuk mengendalikan baki ubat

tersebut.

Maklumat lanjut

- Rupa dan warna produk

Amiohexal 200 tablet adalah bulat, berwarna

putih

dengan

garis

pembelahan

pada

satu

permukaan tablet.

- Bahan-bahan kandungan

- Bahan Aktif:

Setiap biji tablet Amiohexal mengandungi

200mg

Amiodarone hydrochloride

- Bahan tidak aktif:

Polyvidone,

maize

starch,

lactose

monohydrate,

colloidal

silica,

magnesium

stearate.

- Bungkusan

Amiohexal dibungkus dalam pek strip 20, 50

dan 100 biji tablet sekotak.

- Nombor MAL

MAL20014330ACZ

Pengilang

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben, Germany

Bagi:

HEXAL AG

Industriestraße 25,

83607 Holzkirchen,

Germany

Pemegang Pendaftaran Produk

IMEKS Pharma Sdn Bhd.

No.5&9, Jalan Udang Harimau 2,

Medan Niaga Kepong,

51200 Kuala Lumpur.

Tarikh kemaskini RiMUP

6-Julai-2015

Nombor Siri

BPFK(R4/2)060715/00175

22-3-2019

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EU/3/11/887 (DLRC Pharma Services Ltd)

EU/3/11/887 (DLRC Pharma Services Ltd)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1622 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003764

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/886 (DLRC Pharma Services Ltd)

EU/3/11/886 (DLRC Pharma Services Ltd)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1621 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003767

Europe -DG Health and Food Safety

20-2-2019


Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Europe - EMA - European Medicines Agency

20-2-2019


Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Doxolipad,doxorubicin hydrochloride,  31/01/2019,  Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Europe - EMA - European Medicines Agency

31-1-2019


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

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): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

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

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

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