Anzack

Maklumat utama

  • Nama dagangan:
  • Anzack Tablet
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Anzack Tablet
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL06071075
  • 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

ANZACK TABLET

Fluoxetine Hydrochloride (20mg)

Apakah yang ada pada risalah ini

Apakah kegunaan Anzack Tablet

Bagaimana

Anzack

Tablet

berfungsi

Sebelum

menggunakan

Anzack

Tablet

Cara menggunakan Anzack Tablet

Semasa

menggunakan

Anzack

Tablet

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Anzack Tablet

Maklumat lanjut

Pengilang

Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan Anzack Tablet

Fluoxetine

adalah

kandungan

aktif

Anzack

Tablet.

digunakan

untuk

rawatan

simptom-simptom

penyakit

kemurungan yang berkaitan atau tidak

berkaitan

dengan

simptom-simptom

keresahan (perasaan tidak senang hati,

seperti risau atau takut, yang mungkin

ringan atau serius). Ia juga digunakan

untuk

gangguan

obsesif-kompulsif

(gangguan

yang

dicirikan

oleh

pemikiran

yang

berterusan

yang

membawa

kepada

tingkahlaku

berulang)

gangguan

disforik

prahaid

(keadaan

mana

seorang

perempuan

mengalami

simptom

kemurungan yang serius, senang marah

dan rasa tertekan sebelum datang haid).

Bagaimana Anzack Tablet berfungsi

Fluoxetine

adalah

perencat

selektif

pengambilan semula serotonin dan ia

berfungsi dengan bertindak pada bahan

kimia otak.

Sebelum

menggunakan

Anzack

Tablet

Bila tidak boleh menggunakan

Jika

anda

hipersensitif

terhadap fluoxetine atau

bahan-bahan

lain

dalam

Anzack Tablet.

Jika anda pernah atau sedang

mengambil

agen-agen

perencat monoamine oksidase

(MAOIs). Sila beritahu doktor

atau

ahli

farmasi

anda

jika

anda tidak pasti.

Sebelum

menggunakan

Anzack

Tablet

Anda mesti beritahu doktor anda

jika:

Anda

alergi

terhadap

mana-

mana

ubat-ubatan

yang

diambil

sebelum

untuk

merawat keadaan sekarang.

Anda hamil, merancang untuk

hamil atau menyusu.

Anda

mempunyai

sejarah

sawan.

Anda

mempunyai

sejarah

hipomania

(sejenis

bentuk

mania

yang

kurang

serius)/

mania

(keterujaan

yang

dimanifestasikan

dengan

hiperaktif fizikal dan mental,

tingkahlaku yang tidak teratur

dan peningkatan “mood”).

Anda

mempunyai

disfungsi

hati yang ketara.

Anda

mempunyai

kencing

manis.

Anda

mempunyai

masalah

jantung.

Anda mempunyai penurunan

berat badan.

Anda

sedang

mengambil

antikoagulan

oral,

ubat-ubat

yang

mempunyai

kesan

terhadap fungsi platlet, ubat-

ubat

yang

mungkin

meningkatkan

risiko

pendarahan

atau

anda

mempunyai sejarah gangguan

pendarahan.

Jika anda sedang mengambil

ubat-ubat

serotonergik

dan/atau neuroleptik. Bincang

dengan

doktor

atau

ahli

farmasi anda jika anda tidak

pasti.

Kehamilan dan penyusuan:

Kehamilan:

fluoxetine

boleh

digunakan

semasa

hamil

tetapi

dengan

berhati-hati

terutama pada peringkat akhir

kehamilan

atau

sebelum

bersalin,

kesan

berikut

telah

dilaporkan

pada

bayi

yang

baru lahir seperti cepat marah,

geletar,

otot

berkurang,

menangis

berterusan,

sukar

menghisap dan sukar tidur.

Penyusuan:

fluoxetine

metabolitnya,

norfluoxetine,

boleh

dijumpai

dalam

susu

ibu. Kesan sampingan pernah

dilaporkan dalam bayi yang

menyusu.

Jika mengambil ubat-ubat lain

Sila

beritahu

doktor

atau

ahli

farmasi

anda

sekiranya

anda

sedang

mengambil

mana-mana

ubat,

termasuk

tonik

herba,

pelengkap

tambahan

ubat

yang dibeli tanpa preskripsi. Ubat-

ubatan berikut berinteraksi dengan

fluoxetine:

Perencat-perencat monoamine

oksidase

Benzodiazepines

meningkatkan

kepekatan

darah diazepam.

Antidepresan

antidepresan

trisiklik

seperti

nortriptyline,

desipramine,

imipramine

ketoksikan

trisiklik

seperti

mulut

kering,

sembelit

daya ingatan terjejas.

Phenytoin – perubahan paras

Phenytoin dalam darah.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

2

Ubat-ubatan

serotonergik

(ubat-ubatan

yang

mengandungi

serotonin)

meningkatkan risiko sindrom

serotonin (simptom termasuk

peningkatan

kadar

jantung,

menggigil,

berpeluh,

loya,

cirit-birit,

geletar,

sentakan

otot,

tekanan

darah

tinggi,

suhu

badan

tinggi,

agitasi,

kekeliruan dan koma). Guna

bersama

triptan-triptan

meningkatkan

risiko

pengecutan saluran darah dan

tekanan darah tinggi.

Lithium

tryptophan-

sindrom serotonin dilaporkan.

Ubat

yang

dimetabolisme

oleh

isoenzim

CYP2D6

seperti

flecainide,

encainide,

carbamazepine

perlu

diturunkan

paras

rendah

julat dos.

Antikoagulan

oral-

meningkatkan pendarahan.

Alkohol - pengambilan tidak

disarankan.

John‟s

Wort

meningkatkan

kesan-kesan

buruk.

Terapi

elektrokonvulsif

laporan

sawan

berpanjangan

dalam orang yang menerima

Fluoxetine dan rawatan ECT

jarang berlaku.

Cara menggunakan Anzack Tablet

Sentiasa

mengambil

ubat

seperti

yang

diberitahu

oleh

doktor.

Anda

sepatutnya merujuk kepada doktor atau

ahli farmasi anda sekiranya anda tidak

pasti.

Berapa banyak perlu digunakan

Penyakit

kemurungan

yang

berkaitan

atau

tidak

berkaitan

dengan

simptom

simptom

keresahan

Dewasa

warga

tua:

20mg

sehari disarankan.

Gangguan

obsesif-kompulsif:

20mg

hingga

60mg

sehari.

20mg

sehari

disarankan

sebagai

dos permulaan.

Gangguan disforik prahaid: 20mg

sehari.

Rawatan

awal

perlu

dihadkan hingga 6 bulan, selepas

itu, individu harus dinilai semula

mengenai

faedah

untuk

rawatan

diteruskan.

Kegunaan

lain:

yang

disyorkan boleh ditingkatkan atau

diturunkan.

melebihi

80mg/

hari tidak pernah dinilai.

Kanak-kanak:

Penggunaan Anzack Tablet tidak

disarankan

disebabkan

keselamatan

keberkesanan

tidak dapat ditentukan.

Bila perlu digunakan

Doktor anda akan menentukan bila

adalah

sesuai

untuk

anda

menggunakan

Anzack

Tablet

mengikut keadaan anda. Tablet ini

boleh diambil bersama atau tanpa

makanan.

Berapa lama perlu digunakan

Terus

guna

ubat

sepanjang

mana doktor syorkan.

Jika terlupa menggunakan

Sekiranya

anda

terlupa

satu

dos,

ambil

dengan

segera sebaik sahaja teringat.

Tetapi, sekiranya telah hampir

masa

untuk

berikutnya,

abaikan dos yang terlepas.

Jangan

mengambil

berganda untuk menggantikan

dos yang dilupa.

Jika

mengambil

berlebihan

(terlebih dos)

Hubungi

doktor

anda

dengan

segera

atau

pergi

Jabatan

Kecemasan hospital terdekat, jika

terambil dos berlebihan. Ini perlu

dilakukan

walaupun

tiada

sebarang

kesan

keracunan

atau

rasa tidak selesa. Anda mungkin

memerlukan

perhatian

perubatan

segera.

Simptom - simptom: loya, muntah,

sawan, masalah jantung, masalah

paru-paru

tanda-tanda

perubahan

status

sistem

saraf

pusat terjejas yang terdiri daripada

keterujaan hingga koma.

Semasa

menggunakan

Anzack

Tablet

Perkara yang perlu dilakukan

Hubungi

doktor

sekiranya

anda

hamil

semasa

mengambil Anzack Tablet.

Anda

perlu

menghentikan

rawatan ini sekiranya terdapat

ruam atau keadaan alergi.

Anda perlu memantau secara

rapat

pemikiran

bunuh

diri

atau perubahan luar biasa

dalam

tingkah

laku

terutamanya

pada

kanak-

kanak

remaja

dalam

tempoh

beberapa

minggu

pertama rawatan.

Anda

perlu

menghentikan

rawatan

jika

terjadi

sindrom

serotonin atau kejadian serupa

sindrom malignan neuroleptik

– keadaan yang dicirikan oleh

pemanasan badan melampau,

kekakuan, sentakan otot yang

cepat,

ketidakstabilan

sistem

pusat

autonomi

dengan

perubahan

tanda-tanda

vital

dengan

cepat,

perubahan

status

mental

termasuk

kekeliruan,

cepat

marah,

agitasi melampau yang boleh

membawa

delirium

(menjejaskan

kesedaran

daya pemikiran) dan koma.

Perkara

yang

tidak

boleh

dilakukan

Jangan beri Anzack Tablet kepada

orang

lain

walaupun

simptom

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

3

simptom

atau

keadaan

mereka

serupa seperti anda. Doktor anda

mempreskrib Anzack Tablet untuk

anda dan keadaan anda.

Perkara

yang

perlu

diberi

perhatian

Jangan

mengoperasikan

mana-

mana kenderaan atau mesin kerana

Anzack Tablet boleh menjejaskan

daya

pertimbangan,

pemikiran

atau kemahiran motor.

Kesan-kesan sampingan

Seperti ubat-ubat lain, Anzack Tablet

juga

mempunyai

kesan

sampingan

walaupun

bukan

semua

orang

yang

mendapatnya. Kesan-kesan sampingan

berikut mungkin akan terjadi dengan

ubat ini:

Badan:

hipersensitiviti

(gatal,

ruam,

gegata),

seram

sejuk,

sindrom

serotonin,

fotosensitiviti

jarang

sekali

nekrolisis

epidermal

toksik

(keadaan

yang

menyebabkan

sebahagian

besar

lapisan paling luar kulit tertanggal

dari lapisan kulit di bawah).

Sistem

pencernaan:

gangguan

gastrousus

cirit-birit,

loya,

muntah,

dyspepsia

(senak),

disfagia (sukar menelan), perversi

rasa (berubah dari normal), mulut

kering.

Sistem

saraf:

sakit

kepala,

tidur

tidak

normal,

pening,

anoreksia

(kebuluran

diri

penurunan

berat badan yang berlebihan), letih,

euforia (perasaan sangat gembira),

pergerakan

tidak

normal

yang

sementara, sawan dan gelisah dari

segi

psikomotor.

Halusinasi,

reaksi mania, kekeliruan, agitasi,

keresahan,

serangan

panik

jarang sekali sindrom serotonin.

Sistem

urogenital:

penakungan

kencing, kekerapan berkencing.

Gangguan

reproduktif:

disfungsi

seksual, priapisme (keadaan yang

menyebabkan

ereksi

penis

yang

berkekalan dan sakit), galaktorea

(rembesan

susu

payudara

pada

lelaki atau perempuan yang tidak

menyusukan bayi).

Hiponatremia

(paras

garam

natrium

rendah

dalam

darah):

jarang

terbalikkan

apabila

rawatan dihentikan.

Sistem

respiratori:

faringitis

(radang

tekak),

sukar

untuk

bernafas.

Masalah

paru-paru

jarang dilaporkan.

Sekiranya

mana-mana

kesan

sampingan menjadi serius, atau anda

mengalami

kesan

sampingan

yang

tidak

disenaraikan

dalam

risalah

ini,

sila beritahu doktor atau ahli farmasi

anda.

Berjumpa

dengan

doktor

atau

ahli

farmasi anda jika anda was-was atau

untuk maklumat selanjutnya.

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

Anzack Tablet

Penyimpanan

Jangan guna selepas tarikh tamat

tempoh

yang

dinyatakan

pada

bungkusan. Tarikh tamat tempoh

merujuk

kepada

hari

terakhir

bulan tersebut.

Simpan

dalam

bekas

tertutup

bawah

30ºC.

Lindungi

daripada

cahaya,

kepanasan

kelembapan.

Jauhi daripada kanak-kanak.

Pelupusan

Ubat-ubatan

tidak

seharusnya

dilupuskan

melalui

sisa

atau

sisa isi rumah. Tanya ahli farmasi

anda

cara-cara

pelupusan

ubat-

ubatan yang tidak lagi diperlukan.

Langkah-langkah

akan

membantu

melindungi

alam

sekitar.

Maklumat lanjut

Rupa dan warna produk

Tablet

berbentuk

bulat,

berwarna

hijau

muda,

leper,

diameter 7mm dengan garis skor

serta tanda „MPI‟.

Ia dibekalkan dalam pek blister 10

x 10‟s dan 100x10‟s.

Bahan-bahan kandungan

Bahan aktif

Setiap

biji

tablet

mengandungi

bahan

aktif,

fluoxetine

hydrochloride

bersamaan

dengan

20mg

fluoxetine.

Bahan tidak aktif

Bahan-bahan kandungan lain

termasuk

laktosa,

kanji

jagung,

croscarmellose

sodium,

povidone

k-30,

magnesium stearate, colloidal

silicone dioxide, fast green fcf,

quinoline

yellow

isopropyl alcohol.

Nombor MAL

MAL06071075AZ

Pengilang

dan

Pemegang

Pendaftaran Produk

Malaysian Pharmaceutical Industries

Sdn Bhd.

Plot 14, Lebuhraya Kampung Jawa,

11900 Bayan Lepas, Pulau Pinang,

Malaysia.

Tarikh kemaskini RiMUP

23/02/2016

Nombor Siri:

BPFK(R4/1)230216/00054

7-3-2019

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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