Apo-Sertraline

Maklumat utama

  • Nama dagangan:
  • Apo-Sertraline Capsules
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Apo-Sertraline Capsules
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL 0607104
  • Kemaskini terakhir:
  • 31-08-2017

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

APO-SERTRALINE CAPSULES

Sertraline hydrochloride (50mg)

1

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Apakah yang ada pada risalah ini

Apakah kegunaan Apo-Sertraline

Bagaimana Apo-Sertraline berfungsi

Sebelum menggunakan Apo-

Sertraline

Cara menggunakan Apo-Sertraline

Semasa menggunakan Apo-

Sertraline

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Apo-Sertraline

Maklumat lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan Apo-Sertraline

Apo-Sertraline telah diperskripsi kepada

anda oleh doktor untuk melegakan anda

daripada simptom:

kemurungan

kecelaruan panik dengan atau tanpa

agoraphobia

(ketakutan terhadap

keramaian atau ruangan terbuka)

Kecelaruan obsesif kompulsif

obsessive compulsive disorder

OCD) (pemikiran berlarutan dan

berterusan yang menyebabkan

desakan untuk melakukan sesuatu

secara berulang-ulang)

Bagaimana Apo-Sertraline berfungsi

Apo-Sertraline mengandungi sertraline

sebagai bahan aktif. Apo-Sertraline

tergolong dalam kelas ubat yang

dipanggil

Selective Serotonin Reuptake

Inhibitor

(SSRI).

Apo-Sertaline dipercayai berfungsi

dengan meningkatkan ketersediaan

serotonin, iaitu salah satu bahan kimia

dalam otak. Kemurungan dan OCD telah

dihubungkaitkan dengan pengurangan

serotonin di antara sel-sel otak.

Sebelum menggunakan Apo-Sertraline

Bila tidak boleh menggunakan

Anda tidak boleh menggunakan Apo-

Sertraline jika anda alah kepada

sertraline hydrochloride atau sebarang

bahan kandungan dalam ubatan ini.

(rujuk

Maklumat Lanjut

Jangan mengambil Apo-sertraline jika

anda mengambil

Pimozide

(ubat yang

digunakan untuk gangguan mental atau

gangguan sistem saraf)

Monoamine oxidase inhibitor

(MAOI)

Jangan mengambil Apo-Sertraline

sehingga 14 hari selepas berhenti

mana-mana MAOI, dan jangan

mengambil MAOIs sehingga 14 hari

selepas berhenti Apo-sertraline.

Doktor anda akan tahu bila ia selamat

untuk memulakan Apo-Sertraline

selepas MAOI dihentikan.

Kes tindak balas yang serius, kadang-

kadang membawa maut, telah

dilaporkan dalam orang yang

menerima sertraline dalam kombinasi

dengan MAOI, termasuk

selegiline

(digunakan untuk penyakit

Parkinson

moclobemide

(digunakan untuk

kemurungan). Beberapa kes yang

dikemukakan mempunyai ciri-ciri

yang menyerupai sindrom serotonin.

(Sila rujuk

Kesan-kesan Sampingan

Semak dengan doktor atau ahli farmasi

anda jika anda tidak pasti sama ada

anda pernah atau sedang mengambil

MAOI.

Sebelum menggunakan Apo-Sertraline

Sebelum mengambil Apo-Sertraline

doktor anda perlu tahu sebarang

keadaan perubatan lain yang anda

mungkin ada seperti:

mempunyai sejarah sawan

sejarah mania (rasa gembira atau

terlalu teruja, yang menyebabkan

tingkah laku yang tidak biasa) atau

hypomania

(keadaan yang serupa

dengan

mania

tetapi kurang teruk)

masalah hati

masalah buah pinggang

Mengandung dan menyusukan anak

Keselamatan sertraline semasa

mengandung dan penyusuan tidak

dapat dipastikan. Jangan mengambil

Apo-Sertraline jika anda hamil,

menyusukan bayi, cuba untuk hamil

atau fikir anda mungkin hamil kecuali

pada situasi di mana kebaikan kepada

melebihi risiko kepada janin. Tanya

doktor atau ahli farmasi anda untuk

nasihat sebelum mengambil sebarang

ubat.

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 boleh mengganggu

Apo-Setraline. Ini termasuk:

MAOIs (rujuk

bila tidak boleh

menggunakan

pimozide

(rujuk

bila tidak boleh

menggunakan

ubat-ubatan sawan (seperti

carbamazepine, phenytoin

tryptophan

, sejenis asid amino.

St. John Wort

, sejenis herba yang

digunakan untuk merawat

kemurungan

Litium

, sejenis ubat yang

digunakan untuk merawat

penyakit mental.

Tramadol (Untuk kesakitan yang

sederhana hingga teruk),

sumatriptan (Untuk sakit kepala

migrain)

Fenfluramine (Untuk obesiti)

Alkohol

cimetidine (Untuk pedih ulu hati,

ulser perut)

warfarin (Untuk menghalang

pembekuan darah)

Cara menggunakan Apo-Sertraline

Berapa banyak harus digunakan

Ikut arahan doktor atau ahli farmasi

anda dengan teliti. Ia mungkin berbeza

dari maklumat pada risalah ini. Jika

anda tidak memahami arahan pada

label ubat anda, sila rujuk kepada

doktor atau ahli farmasi.

Kemurungan dan Kecelaruan Obsesif-

kompulsif

: Dos sebanyak 50 mg / hari

disyorkan sebagai dos awal.

Kecelaruan panik

: Rawatan Apo-

Setraline harus dimulakan dengan dos

25 mg sekali sehari.

2

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Titratan

: Dalam kecelaruan bersifat

secara beransur-ansur seperti

kemurungan, OCD dan kecelaruan

panik, peningkatan dos secara

berperingkat boleh dipertimbangkan

sekiranya tiada penambahbaikan

klinikal diperhatikan. Dos tidak boleh

melebihi maksimum 200 mg / hari.

Respons terapi sepenuhnya mungkin

tertunda sehingga 4 minggu rawatan

atau lebih.

Dos pengekalan

: Semasa terapi jangka

panjang bagi apa-apa indikasi, dos

perlu dikekalkan pada dos terendah

yang berkesan dan anda perlu dinilai

semula dari semasa ke semasa untuk

menentukan keperluan untuk rawatan

yang berterusan.

Jika anda menghadapi masalah hati,

doktor mungkin membuat keputusan di

mana anda harus mengambil dos Apo-

Sertraline yang lebih rendah.

Apo-sertraline tidak boleh digunakan

dalam rawatan kanak-kanak dan

remaja di bawah umur 18 tahun

dengan gangguan utama depresi.

Bila perlu digunakan

Ikut arahan doktor atau ahli farmasi

anda.

Apo-Sertraline perlu diambil dengan

makanan sekali sehari, sebaik-baiknya

dengan makan malam. Jika anda

memilih untuk mengambil ia pada

waktu pagi, ambil dengan sarapan

pagi.

Berapa lama perlu digunakan

Teruskan penggunaan ubat ini untuk

tempoh masa yang ditetapkan oleh

doktor anda.

Jika terlupa menggunakan

Rujuk kepada doktor atau ahli farmasi

anda tentang apa yang perlu dilakukan

jika anda terlupa menggunakan ubat

ini.

Ambil dos yang terlepas sebaik sahaja

anda teringat. Sekiranya sudah hampir

masa untuk dos seterusnya, abaikan

dos terlepas dan tunggu untuk

mengambil dos seterusnya pada masa

biasa. Jangan ambil dos berganda

untuk menggantikan dos yang

tertinggal.

Jika mengambil berlebihan (terlebih

dos)

Hubungi doktor anda dengan segera

atau pergi ke 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.

Gejala dos berlebihan dengan

sertraline sahaja termasuk sifat tidur,

mengantuk, loya, muntah,

tachycardia

(kadar degupan jantung laju),

keresahan dan anak mata membesar.

Semasa menggunakan Apo-Sertraline

Perkara yang perlu dilakukan

Ambil ubat anda mengikut arahan

doktor.

Maklumkan kepada semua doktor,

doktor gigi dan ahli farmasi yang

merawat anda bahawa anda sedang

menggunakan Apo-Sertraline.

Beritahu doktor anda dengan segera

jika anda menjadi hamil semasa

menggunakan ubat ini.

Perkara yang tidak boleh dilakukan

Jangan berhenti menggunakan ubat ini

kecuali diarahkan oleh doktor anda.

Doktor anda mungkin menginginkan

anda mengurangkan jumlah

pengambilan Apo-Setraline anda

secara beransur-ansur sebelum

berhenti sepenuhnya. Ini akan

membantu mengurangkan peluang

simptom pemberhentian ubatan

(seperti pening,

paraesthesia

(sensasi

mencucuk), sakit kepala, perasaan

resah dan loya)

Jangan mula mengambil sebarang ubat

baru tanpa berbincang dengan doktor

atau ahli farmasi anda.

Jangan memberi Apo-Sertraline

kepada sesiapa, walaupun mereka

mempunyai simptom atau keadaan

yang sama dengan anda.

Perkara yang perlu diberi perhatian

Memandu dan menggunakan jentera

Ubat ini mungkin mengganggu

keupayaan anda untuk memandu atau

mengendalikan jentera, Jika ubat ini

menyebabkan anda terasa loya, pening,

letih, atau sakit kepala, jangan

memandu atau mengendalikan jentera

dan hubungi doktor anda dengan

segera.

Perasaan ingin mati dalam Kanak-

kanak dan Remaja

Apo-sertraline meningkatkan risiko

pemikiran ingin membunuh diri dan

tingkah laku sebegitu pada kanak-

kanak. Walaupun begitu, doktor anda

boleh menetapkan Apo-sertraline

untuk anda atau anak anda apabila dia

memutuskan bahawa ini adalah dalam

rawatan terbaik untuk mereka.

Jika doktor anda telah menetapkan

Apo-sertraline untuk seseorang yang

berumur di bawah 18 dan anda ingin

membincangkan tentang perubatan ini,

sila kembali ke doktor anda. Keluarga

atau penjaga perlu memberi tumpuan

kepada anak anda setiap kali Apo-

sertraline dimulakan atau ketika

terdapat perubahan dalam dos.

Hubungi doktor anda jika anda

mendapati apa-apa perubahan secara

tiba-tiba atau luar biasa berlaku pada

kamu atau tingkah laku anak anda

Kesan-kesan sampingan

Seperti ubat-ubatan lain, Apo-Sertraline

boleh menyebabkan kesan sampingan,

walaupun bukan semua orang

mengalaminya.

Jika anda mengalami kesan sampingan

yang sangat serius berikut, berhenti

mengambil Apo-sertraline dan beritahu

doktor anda dengan segera atau hubungi

hospital yang terdekat:

alahan termasuk ruam kulit, bengkak

pada muka, bibir, lidah atau tekak,

3

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

kesukaran bernafas

pemikiran membunuh diri atau cuba

membunuh diri atau mencederakan diri

sendiri

sindrom serotonin termasuk demam

yang sangat tinggi, kekejangan otot,

degupan jantung yang pantas,

kekeliruan, dan koma.

Anda mungkin mengalami beberapa

kesan sampingan seperti:

Kardiovaskular

: gangguan tekanan darah

Gastro-usus

: muntah, sakit perut.

Gangguan mata

: penglihatan tidak

normal.

Sistem saraf

amnesia

(ingatan menjadi

lemah), sakit kepala,

mengantuk, gangguan pergerakan,

halusinasi (pemikiran sesuatu yang tidak

wujud), tindak balas agresif, kegelisahan,

keresahan.

Sawan

sertraline

perlu dihentikan untuk

orang yang mengalami sawan.

Rangka Otot

: sakit otot atau sakit sendi.

Hati / pankreas

: Jarang berlaku,

keradangan pankreas dan masalah hati

yang serius.

Gangguan buah pinggang

: pengekalan

air kencing.

Reproduktif

Hyperprolactinemia

(hormon tertentu berlebihan),

galactorrhoea

(penghasilan susu secara

berlebihan ataupun secara tidak wajar),

haid tidak tetap.

Kulit dan reaksi alergi

: Ruam,

angioedema

(bengkak pada muka, bibir,

tangan dan tapak kaki).

Metabolik

: Jarang berlaku: hyponatremia

(tahap sodium yang rendah dalam badan

anda.)

Haematologik (darah)

: Fungsi platlet

terubahsuai dan/atau keputusan makmal

klinikal tidak biasa telah dilaporkan.

Trombositopenia

(penurunan bilangan

platelet darah), pendarahan yang tidak

normal atau

purpura

(perdarahan dalam

kulit yang dicirikan oleh bintik-bintik

ungu kemerahan) pada beberapa orang

yang mengambil sertraline telah

dilaporkan tetapi adalah tidak jelas sama

ada sertraline adalah penyebab.

Am

Malaise

(perasaan tidak selesa).

Kesan sampingan yang lain tidak

disenaraikan di atas juga boleh berlaku

pada sesetengah orang.

Jumpa doktor atau ahli farmasi anda

dengan segera jika anda mengalami

sebarang kesan sampingan selepas

menggunakan ubat ini.

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

Apo-Sertraline

Penyimpanan

Jauhi semua ubat daripada kanak-

kanak.

Simpan pada suhu 15-25 °C.

Pelupusan

Ubat-ubatan tidak harus dilupuskan

melalui air buangan atau sisa isi

rumah. Sila rujuk kepada ahli farmasi

anda mengenai cara yang betul untuk

melupuskan ubat yang tidak

diperlukan lagi. Langkah-langkah ini

dapat membantu melindungi alam

sekitar.

Maklumat lanjut

Rupa dan warna produk

Apo-Sertaline 50 mg ialah kapsul

gelatin keras dengan badan legap

berwarna putih, penutup legap

berwarna kuning, tertera APO 50, dan

berisi serbuk putih hingga putih sejuk.

Setiap kapsul mengandungi

sertraline

hydrochloride

bersamaan dengan 50

mg sertraline.

Bahan-bahan kandungan

Bahan aktif

Sertraline hydrochloride

Bahan tidak aktif

Croscarmellose sodium, stearic

acid, colloidal silicon dioxide and

starch (corn), talc

Penutup kapsul yang dicetak dengan

dakwat hitam yang boleh dimakan

mengandungi bahan bukan ubat

seperti gelatin, titanium dioxide,

D&C yellow #10 and FD&C yellow

#6..

Nombor MAL

MAL 06071046AZ

Pengilang

Apotex Inc.

150 Signet Drive

Weston Toronto Ontario

M9L 1T9 Canada

Pemegang Pendaftaran Produk

Pharmaforte (M) Sdn Bhd

2, Jalan PJU 3/49

Sunway Damansara

47810 Petaling Jaya

Tarikh kemaskini RiMUP

03/03/2016

Nombor Siri

BPFK(R4/1)241115/00454

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16-1-2019

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho pouches due to an unlabeled peanut allergen.

FDA - U.S. Food and Drug Administration

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

11-12-2018

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

The recalled product does not have proper consumer chemical hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

18-3-2019


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

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

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

Europe - EMA - European Medicines Agency

18-3-2019


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

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

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

Europe - EMA - European Medicines Agency

18-3-2019


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

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

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

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

6-3-2019

Fortekor and associated names

Fortekor and associated names

Fortekor and associated names (Active substance: Benazepril hydrochloride) - Corrigendum - Commission Decision (2012)772 of Wed, 06 Mar 2019

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/888 (DLRC Pharma Services Ltd)

EU/3/11/888 (DLRC Pharma Services Ltd)

EU/3/11/888 (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)1623 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003766

Europe -DG Health and Food Safety

26-2-2019

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

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

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