Acugesic

Maklumat utama

  • Nama dagangan:
  • Acugesic
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Acugesic
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL19950160, MAL19950161
  • 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)

1

ACUGESIC TABLET/CAPSULE

Tramadol hydrochloride (50mg)

Apakah

yang

ada

pada

risalah ini

Apakah

kegunaan

ACUGESIC tablet/ capsule

Bagaimana

ACUGESIC

tablet/ capsule berfungsi

Sebelum

menggunakan

ACUGESIC tablet/ capsule

Cara

menggunakan

ACUGESIC tablet/ capsule

Semasa

menggunakan

ACUGESIC tablet/ capsule

Kesan-kesan sampingan

Cara

penyimpanan

pelupusan

ACUGESIC

tablet/ capsule

Maklumat lanjut

Pengilang

Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah

kegunaan

ACUGESIC tablet/capsule

ACUGESIC

tablet/capsule

ialah sejenis ubat penahan sakit

yang digunakan untuk merawat

kesakitan teruk jenis akut dan

kronik.

ACUGESIC

tablet/capsule

adalah

ubat

untuk

melegakan

kesakitan,

contohnya

kesakitan

luka,

patah

tulang,

sakit

saraf

yang

teruk,

sakit

tumor,

serangan

jantung.

tidak

boleh

digunakan

untuk

kecederaan ringan. Kesannya

cepat dan berlangsung selama

beberapa jam.

Bagaimana

ACUGESIC

tablet/capsule berfungsi

ACUGESIC

tablet/capsule

mengandungi

bahan

aktif

Tramadol.

Tramadol

ialah

ubat tahan sakit yang tergolong

dalam

kelas

opioid

yang

bertindak

pada

sistem

saraf

pusat. Ia melegakan kesakitan

dengan bertindak pada sel saraf

pada otak dan saraf tunjang.

Sebelum

menggunakan

ACUGESIC tablet/ capsule

Bila

tidak

boleh

menggunakan

Jangan mengambil ubat ini jika

anda

mengalami

mana-mana

yang berikut:

Anda

telah

mengambil

alkohol,

hipnotik

(ubat

untuk

tidur),

analgesik

(ubat tahan sakit), atau ubat

lain

yang

bertindak

pada

otak

saraf

tunjang

dalam kuantiti yang banyak

baru-baru ini.

Anda

alah

atau

pernah

mengalami

reaksi

alahan

terhadap

ubat

tramadol,

opiod

yang

lain

atau

sebarang

bahan

kandungannya

yang

disenaraikan

akhir

risalah ini.

Gejala

reaksi

alahan

kepada

ubat-ubatan

termasuk:

batuk,

sesak

nafas,

berdehit

atau

kesukaran

bernafas,

bengkak

muka,

bibir,

lidah,

tekak

atau

bahagian-bahagian

lain

badan,

ruam,

gatal-gatal

pada kulit; pitam

Jika

anda

mengalami

tindak

balas

alahan,

hentikan

pengambilan ubat tersebut dan

hubungi

doktor

anda

dengan

segera

atau

pergi

hospital

yang berdekatan.

Sebelum

menggunakan

ACUGESIC tablet/ capsule

Beritahu doktor anda, jika anda:

Masalah buah pinggang dan

hati

Kecederaan

kepala

yang

teruk

atau

tekanan

pada

otak yang meningkat

jika

anda

mengalami

myasthenia gravis (penyakit

otot menyebabkan melabuh

kelopak

mata,

penglihatan

berganda, kesukaran untuk

bercakap dan menelan, dan

kadang-kadang

lemah

otot

di tangan atau kaki)

anda mempunyai masalah

ketagihan

dadah

atau

alkohol.

Anda hamil atau merancang

untuk hamil. ACUGESIC

tablet/capsule

tidak

disyorkan untuk digunakan

semasa mengandung. Oleh

itu, jika terdapat keperluan

untuk

mengambil

ACUGESIC

tablet/capsule

semasa

kehamilan,

doktor

anda akan membincangkan

risiko dan manfaat dengan

anda.

Jika

anda

sedang

atau

merancang

untuk

menyusukan bayi.

Penggunaan

ACUGESIC

tablet/capsule

tidak

disyorkan

ketika

penyusuan

bayi.

Berbincanglah

dengan

doktor

anda

mengenai

risiko

manfaat

penggunaan

ACUGESIC

tablet/capsule

ketika penyusuan bayi.

Jika mengambil ubat-ubat

lain

Beritahu

doktor

jika

anda

menggunakan

sebarang

ubat

lain, termasuk ubat yang dibeli

tanpa

preskripsi

dari

farmasi,

pasaraya, atau kedai makanan

kesihatan.

Sesetengah

ubat

ACUGESIC

tablet/capsule

boleh

bertindak

balas

antara

satu sama lain. Ini termasuk:

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

2

central

nervous

system

(ubat-ubatan

untuk

membantu

anda

tidur

seperti,

traquilizers

hypnotics)

Monoamine

oxidase

inhibitors

(MAOIs)

(selalunya

diambil

untuk

depresi)

Ubat-ubatan

mungkin

dipengaruhi

oleh

ACUGESIC

tablet/capsule

atau

mungkin

menjejaskan

fungsinya.

Anda

mungkin perlu mengambil ubat

anda

dalam

jumlah

yang

berlainan

atau

anda

mungkin

perlu

mengambil

jenis

ubat

yang berlainan.

Doktor dan ahli farmasi anda

mempunyai

lebih

banyak

maklumat

tentang

ubat

lain

yang

perlu

diberi

perhatian

atau

dielakkan

semasa

anda

mengambil

ACUGESIC

tablet/capsule.

Cara

menggunakan

ACUGESIC tablet/ capsule

Berapa

banyak

harus

digunakan

Doktor anda akan memberitahu

anda berapa banyak yang harus

diambil. Ini bergantung kepada

keadaan

anda

sama

anda

mengambil

sebarang

ubat-ubatan lain.

Dos untuk orang dewasa dan

remaja

berumur

tahun

atas :

kapsul

tablet

yang

perlu

diambil

dengan

cecair

yang

sedikit.

biasanya

mencukupi

untuk

melegakan

kesakitan. Bagaimanapun, jika

kesakitan

tidak

berkurangan,

ambil

tramadol

kapsul/tablet

selepas kira-kira 30-60 minit.

Jika fungsi buah pinggang atau

hati

terjejas

ambil

yang

disarankan doktor anda.

Jangan mengambil lebih dari 8

tablet/capsule (400mg) sehari.

Bila perlu digunakan

Ambil

ACUGESIC

tablet/

capsule seperti yang diarahkan

oleh

doktor

anda.

Jangan

mengambil

yang

lebih

daripada yang diarahkan oleh

doktor anda.

Jangan

mengambil

ACUGESIC

tablet/capsule

bersama dengan alkohol.

Anda

boleh

mengambil

ACUGESIC

tablet/capsule

dengan atau tanpa makanan.

Berapa

lama

perlu

digunakan

Anda

tidak

boleh

mengambil

Acugesic

tablet/kapsul

untuk

lebih lama daripada perlu. Jika

anda

perlu

dirawat

untuk

tempoh

yang

lebih

lama,

doktor

anda

akan

memeriksa

pada jangka masa yang pendek

(jika perlu dengan rehat dalam

rawatan) sama ada anda perlu

terus

mengambil

Acugesic

tablet

kapsul

pada

tertentu.

Jika

anda

mempunyai

tanggapan

bahawa

kesan

Acugesic tablet / kapsul terlalu

kuat

atau

terlalu

lemah,

bincang

dengan

doktor

atau

ahli farmasi anda.

Teruskan

penggunaan

ACUGESIC

tablet/capsule

untuk

tempoh

masa

yang

ditetapkan oleh doktor anda.

Jika terlupa menggunakan

Sekiranya anda tertinggal satu

dos,

ambillah

yang

tertinggal

sebaik

sahaja

anda teringat. Dos seterusnya

perlu

diambil

sebagaimana

yang

ditetapkan

oleh

doktor

anda.

Jangan

gandakan

anda

sekiranya

anda

terlupa

mengambil

yang

sebelumnya.

Jika mengambil berlebihan

(terlebih dos)

Jika anda fikir anda atau orang

lain

mungkin

terlebih

mengambil

ACUGESIC

tablet/capsule, hubungi doktor

anda

untuk

mendapatkan

nasihat atau pergi ke bahagian

kecemasan

hospital

yang

terdekat

dengan

segera.

mesti

dilakukan

walaupun

tiada

tanda

ketidakselesaan

atau keracunan. Anda mungkin

memerlukan rawatan perubatan

dengan segera.

Jika

anda

mengambil

terlalu

banyak

ACUGESIC

tablet

kapsul (berlebihan), ini boleh

menyebabkan

kegelisahan,

kebimbangan,

gegaran,

meningkatkan refleks.

Semasa

menggunakan

ACUGESIC tablet/ capsule

Perkara

yang

perlu

dilakukan

Sebelum

mula

mengambil

ubat-ubatan

lain,

maklumkan

kepada doktor atau ahli farmasi

bahawa

anda

sedang

mengambil ACUGESIC tablet/

capsule.

Jika sakit anda telah lega dan

anda merasakan bahawa anda

tidak

perlu

mengambil

ACUGESIC

tablet/capsule

seperti

yang

telah

diarahkan,

berjumpalah

dengan

doktor

anda.

Maklumkan kepada doktor jika

sakit

anda

bertambah

teruk.

Jangan

ambil

tambahan

tanpa pengetahuan doktor anda.

Perkara yang tidak boleh

dilakukan

Jangan

beri

ACUGESIC

tablet/capsule

kepada

orang

lain walaupun penyakit mereka

sama seperti anda.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

3

Jangan

guna

ACUGESIC

tablet/capsule

untuk

merawat

penyakit

lain

kecuali

atas

arahan doktor anda.

Perkara yang perlu diberi

perhatian

Jangan

memandu

kenderaan

atau

mengendalikan

mesin

sehingga

anda

merasai

kesan

ACUGESIC

tablet/capsule

terhadap anda.

ACUGESIC

tablet/capsule

boleh menyebabkan anda rasa

pening.

Kesan-kesan sampingan

Rujuk

doktor

anda

secepat

mungkin jika anda ada masalah

ketika mengambil ACUGESIC

tablet/capsule,

walaupun

anda

tidak

fikir

masalah

yang

berkaitan

dengan

ubat

atau

tidak

disenaraikan

dalam

risalah ini.

Seperti

ubat-ubatan

lain,

ACUGESIC

tablet/capsule

boleh

menyebabkan

kesan

sampingan.

Jika

berlaku,

kesannya

sementara.

Walau

bagaimanapun,

sesetengah

kesan

sampingan

mungkin

serius

anda

mungkin

memerlukan

perhatian

perubatan dengan segera.

Tanya doktor atau ahli farmasi

anda untuk maklumat lanjut.

Laporkan

kepada

doktor

jika

anda

mengalami

kesan

sampingan

berikut

ianya

membimbangkan anda.

Kesan

sampingan

yang

biasa

berlaku:

Pening

Letih

Loya atau muntah

Berpeluh

Mulut kering

Sukar bernafas

Jika Acugesic tablet / kapsul

diambil

dalam

tempoh

masa

yang

lama,

pergantungan

mungkin

berlaku.

Apabila

rawatan dihentikan secara tiba-

tiba simptom penarikan boleh

muncul.

Anda

mungkin

mengalami

kesan-kesan

sampingan

lain

yang tidak disenaraikan di atas.

Laporkan

kepada

doktor

jika

anda

mengalami

sebarang

kesan

sampingan

yang

membuatkan anda berasa tidak

sihat.

Anda

boleh

melaporkan

sebarang kesan sampingan atau

kesan advers ubat kepada Pusat

Pemantauan

Kesan

Advers

Ubat Kebangsaan melalui No.

Tel: 03-78835550, atau laman

portal.bpfk.gov.my

(Consumers

Reporting).

Cara

penyimpanan

dan

pelupusan

ACUGESIC

tablet/capsule

Penyimpanan

Simpan ubat anda di dalam pek

asal sehingga tiba masa untuk

menggunakannya.

Jika

anda

mengeluarkan

ubat

daripada pek asalnya, ia tidak

tersimpan dengan sempurna.

Simpan

ubat

anda

tempat

kering

sejuk

pada

suhu

bawah 25°C.

Jangan

simpan

ACUGESIC

tablet/capsule

atau

ubat

lain

dalam

bilik

mandi

atau

berhampiran dengan sinki.

Jangan

tinggalkan

ubat

dalam

kereta

atau

atas

unjuran tapak tingkap.

Haba

kelembapan

boleh

merosakkan ubat.

Pastikan

ubat

sentiasa

dijauhkan

daripada

kanak-

kanak.

Almari

yang

berkunci

sekurang-kurangnya

satu

setengah meter dari aras lantai

adalah

tempat

yang

sesuai

untuk menyimpan ubat.

Pelupusan

Jika doktor atau farmasi anda

mengarahkan

anda

berhenti

mengambil

ACUGESIC

tablet/capsule,

atau

sudah

tamat tarikh luputnya, hubungi

ahli

farmasi

anda

untuk

mengetahui

yang

perlu

dilakukan

terhadap

baki

tersebut.

Maklumat lanjut

Rupa dan warna produk

ACUGESIC

TABLET

50MG

Berbentuk empat segi sama,

diameter

7mm,

berwarna

hijau

epal

dengan

tanda

‘duo

861’

pada

permukaannya.

ACUGESIC

CAPSULE

50MG

Berwarna

hitam/hijau

dengan

tanda

‘DUO

861’

pada permukaanya

Bahan-bahan kandungan

ACUGESIC

TABLET

50MG

Bahan aktif:

Tramadol hydrochloride

Bahan-bahan tidak aktif:

Quinoline Yellow

Sodium

Starch

Glycolate

Brilliant Blue FCF

Polyviynlprrolidone

(PVP)

Cornstarch

Magnesium Stearate

Silicon Dioxide

Lactose

ACUGESIC

CAPSULE

50MG

Bahan aktif:

Tramadol hydrochloride

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

4

Bahan-bahan tidak aktif:

Lactose

Magnesium stearate

Nombor MAL

ACUGESIC

TABLET

50MG

MAL19950160AZ

ACUGESIC

CAPSULE

50MG

MAL19950161AZ

Pengilang

Duopharma

Sdn.

Bhd.

(42491-M)

Lot. 2599, Jalan Seruling 59,

Kawasan 3, Taman Klang Jaya,

41200 Klang, Selangor Darul

Ehsan, Malaysia.

Pemegang

Pendaftaran

Produk

Duopharma

Sdn.

Bhd.

(42491-M)

Lot. 2599, Jalan Seruling 59,

Kawasan 3, Taman Klang Jaya,

41200 Klang, Selangor Darul

Ehsan, Malaysia.

Tarikh kemaskini RIMUP

12/11/2015

Nombor Siri

BPFK(R4/1)121115/00416

7-3-2019

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28-11-2018

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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

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

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety