Actifed

Maklumat utama

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

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Actifed® Syrup
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL19860257
  • Kemaskini terakhir:
  • 31-08-2017

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

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

ACTIFED

®

SYRUP

Pseudoephedrine hydrochloride/Triprolidine hydrochloride (30 mg/1.25 mg per 5 ml)

Apakah yang ada pada risalah

ini

Apakah kegunaan ACTIFED

Bagaimana ACTIFED

berfungsi

Sebelum mengambil

ACTIFED

Cara menggunakan ACTIFED

Semasa menggunakan

ACTIFED

Kesan-kesan sampingan

Cara penyimpanan dan

pelupusan ACTIFED

Maklumat Lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan ACTIFED

Sirap ACTIFED merupakan

sejenis ubat yang digunakan

untuk melegakan simptom-

simptom gangguan saluran

pernafasan atas seperti rinitis

alergi (radang membran mukus

dalam hidung), vasomotor

(bukan alahan) rinitis, selesema

biasa dan influenza termasuk

bersin, hidung berair, mata

berair, hidung tersumbat dan

sinus tersumbat.

Bagaimana ACTIFED

berfungsi

ACTIFED mengandungi

pseudoephedrine hydrochloride

yang merupakan sejenis

dekongestan yang berfungsi

dengan menyempitkan saluran

darah bagi mengurangkan

bengkak dan hidung tersumbat

dan triprolidine hydrochloride

yang merupakan sejenis

antihistamina yang berfungsi

dengan menyekat bahan

semulajadi tertentu (histamina)

yang dihasilkan oleh badan anda

semasa reaksi alahan.

Sebelum mengambil

ACTIFED

Bila tidak boleh mengambil

Jangan gunakan ubat ini jika:

Anda alah terhadap

pseudoephedrine, triprolidine,

atau mana-mana bahan

kandungan lain.

Anda mempunyai tekanan

darah yang sangat tinggi atau

penyakit jantung yang teruk.

Anda sedang mengambil, atau

telah mengambil dalam masa

dua minggu yang lalu, ubat-

ubat untuk kemurungan yang

dikenali sebagai Penyekat

Monoamine Oxidase

(MAOIs).

Anda sedang mengambil

produk –produk yang

mengandungi antihistamina

Anda sedang mengambil ubat-

ubat lain untuk melegakan

batuk, selesema, kongesi atau

hidung tersumbat.

Sebelum mula mengambil

Berjumpa dengan doktor atau

ahli farmasi anda jika anda:

Mempunyai masalah hati atau

buah pinggang

Mempunyai tekanan darah

tinggi atau penyakit jantung

Mempunyai degupan jantung

yang tidak teratur

Mempunyai diabetes atau jika

anda pernah diberitahu oleh

doktor anda bahawa anda

mempunyai ketidaktoleransi

terhadap sesetengah gula

Mempunyai kelenjar tiroid

yang terlalu aktif

Mempunyai glaukoma

(peningkatan tekanan dalam

mata)

Mempunyai masalah prostat

(kesukaran membuang air

kencing atau perlu membuang

air kencing dengan kerap)

Mempunyai epilepsi atau asma

Mempunyai bronkitis (radang

saluran udara) atau

bronchiectasis (saluran udara

paru-paru menjadi lebar secara

tidak normal)

Phaeochromocytoma

(ketumbuhan yang jarang

ditemui pada kelenjar adrenal

yang terletak di atas buah

pinggang)

Tanya doktor atau ahli farmasi

anda untuk nasihat sebelum

mengambil ubat ini jika anda

hamil atau sedang menyusukan

anak.

Jika mengambil ubat-ubat lain

Berjumpa dengan doktor atau

ahli farmasi anda jika anda

sedang mengambil sebarang

ubat lain, termasuk:

Sedatif (ubat-ubat yang

digunakan untuk merawat

keresahan dan ketegangan).

Antihipertensif (ubat-ubat

yang digunakan untuk

merawat tekanan darah tinggi

seperti guanethidine,

methyldopa, penyekat alfa dan

beta serta debrisoquine),

Ubat-ubat simpatomimetik

(perangsang atau penahan

selera makan dan ubat-ubat

yang digunakan untuk

merawat kongesi dan asma).

Jika anda tidak pasti tentang

sebarang ubat yang anda sedang

ambil, tunjukkan botol atau pek

itu kepada ahli farmasi anda.

Cara menggunakan ACTIFED

Berapa banyak harus

digunakan

Dewasa dan kanak-kanak

berumur 12 tahun dan ke atas:

Sirap 10 ml setiap 4-6 jam,

diambil secara oral.

Dos harian maksimum: Sirap

40 ml dalam masa 24 jam

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Kanak-kanak berumur 6 hingga

11 tahun:

Sirap 5 ml setiap 4-6 jam,

diambil secara oral.

Dos harian maksimum: Sirap

20 ml dalam masa 24 jam

Kanak-kanak berumur 2 hingga

5 tahun:

Sirap 2.5 ml setiap 4-6 jam,

diambil secara oral.

Dos harian maksimum: Sirap

10 ml dalam masa 24 jam

Tidak harus digunakan untuk

kanak-kanak berumur kurang

daripada 2 tahun. Untuk

digunakan dengan berhati-hati

dengan nasihat doktor/ahli

farmasi anda bagi kanak-kanak

berumur 2 hingga 6 tahun.

Bila perlu digunakan

Gunakan sebagaimana yang

diarahkan oleh doktor atau ahli

farmasi anda.

Berapa lama perlu digunakan

Terus mengambil ACTIFED

untuk jangka masa yang

disyorkan oleh doktor anda. Sila

dapatkan nasihat perubatan jika

simptom-simptom berterusan

lebih daripada 7 hari.

Jika terlupa menggunakan

Jika anda terlupa mengambil

satu dos, ambil dos seterusnya

jika perlu dengan syarat dos

terakhir diambil sekurang-

kurangnya 4 jam yang lepas.

Jangan ambil dos berganda

untuk menggantikan dos yang

tertinggal.

Jika mengambil berlebihan

(terlebih dos)

Hubungi doktor anda dengan

segera atau pergi ke Jabatan

Kecemasan di hosopital yang

terdekat jika anda rasa anda atau

sesiapa sahaja mungkin telah

terlebih mengambil ubat ini.

Lakukannya walaupun tiada

tanda-tanda ketidakselesaan atau

keracunan. Anda mungkin

memerlukan rawatan perubatan

segera.

Pseudoephedrine yang

berlebihan boleh menyebabkan

simptom-simptom yang

disebabkan oleh sistem saraf

pusat dan rangsangan

kardiovaskular (contohnya

kegembiraan, keresahan,

halusinasi, darah tinggi dan

degupan jantung tidak seragam.

Dalam kes-kes yang teruk,

psikosis, sawan, koma dan

peningkatan tekanan darah yang

sangat tinggi mungkin berlaku.

Kandungan potasium yang

rendah dalam darah mungkin

berlaku.

Tripolidine yang berlebihan

berkemungkinan untuk

menyebabkan kesan yang sama

seperti yang disenaraikan di

dalam kesan-kesan sampingan.

Simptom-simptom tambahan

termasuk hilang kawalan

pergerakan , kelemahan,

kekurangan upaya untuk

bernafas, kekeringan kulit dan

mukus membran, demam panas

yang sangat tinggi, gegaran,

psikosis, sawan, kadar degupan

jantung yang terlalu laju dan

degupan jantung tidak seragam.

Semasa menggunakan

ACTIFED

Perkara yang perlu dilakukan

Berjumpa dengan doktor atau

ahli farmasi anda sebelum

mengambil ubat anda dan

mengambilnya seperti yang

dipreskripsikan oleh doktor

anda.

Beritahu semua doktor, doktor

pergigian dan ahli farmasi yang

merawat anda bahawa anda

sedang mengambil ACTIFED.

Beritahu doktor anda dengan

segera jika anda hamil semasa

mengambil ubat ini.

Perkara yang tidak boleh

dilakukan

Ubat ini hanya dipreskripsikan

untuk anda sahaja. Jangan

berinya kepada orang lain. Ia

mungkin memudaratkan mereka,

walaupun gejala mereka sama

dengan anda.

Jangan melebihi kekerapan dos.

Perkara yang perlu diberi

perhatian

Ubat ini mungkin akan

menjejaskan kebolehan anda

untuk memandu atau

mengendalikan jentera dan ia

mungkin menyebabkan

mengantuk, pening dan

penglihatan yang kabur. Jika

terjejas jangan memandu atau

mengendalikan jentera.Elakkan

minuman beralkohol.

ACTIFED mengandungi 3.93g

sukrosa dalam setiap5 ml. Ini

harus diambil kira sekiranya

anda menghidapi kencing manis.

Kanak-kanak dan warga tua

lebih cenderung mendapat kesan

sampingan.

Kesan-kesan sampingan

ACTIFED boleh menyebabkan

kesan-kesan sampingan, seperti

semua ubat, tetapi bukan setiap

orang mengalami mereka dan

biasanya adalah ringan.

Semasa menggunakan produk

ini anda mungkin akan

mengalami:

Kesan sedasi dan mengantuk

yang biasa berlaku

Gemuruh, sukar tidur, pening,

mulut, hidung atau tekak

kering, loya, muntah-muntah,

gangguan dalam tumpuan dan

koordinasi yang tidak normal

yang mungkin kadang-kadang

berlaku.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Halusinasi (terutamanya

dalam kalangan kanak-kanak)

yang jarang dilaporkan.

Berhenti menggunakan produk

ini dan dapatkan nasihat doktor

anda jika anda mengalami:

Sakit perut secara tiba-tiba

atau darah dalam najis anda.

Sakit kepala yang teruk secara

tiba-tiba

Kesukaran untuk membuang

air. Ini lebih berkemungkinan

berlaku jika anda menghidapi

pembesaran kelenjar prostat.

Reaksi alahan seperti ruam

kulit, kadang-kadang bersama

dengan masalah pernafasan

atau pembengkakkan muka

dan/atau tekak, Reaksi-reaksi

ini jarang berlaku.

Jika anda mengalami sebarang

kesan sampingan yang tidak

tersenarai dalam risalah ini atau

tidak pasti tentang apa-apa,

berjumpa dengan doktor atau

ahli farmasi anda.

Anda boleh melaporkan

sebarang kesan sampingan atau

kesan advers ubat kepada Pusat

Pemantauan Kesan Advers Ubat

Kebangsaan melalui No. Tel:

03-78835550, atau laman

webportal.bpfk.gov.my

(Consumers

Reporting)

Cara penyimpanan dan

pelupusan ACTIFED

Penyimpanan

Simpan di bawah suhu 25

Simpan di dalam pakej asal

untuk melindunginya daripada

cahaya dan kelembapan.

Jauhkan produk ini daripada

capaian dan penglihatan kanak-

kanak.

Jangan gunakan selepas akhir

bulan yang ditunjukkan sebagai

tarikh luput atas bungkusan.

Pelupusan

Ubat-ubat tidak harus

dilupuskan melalui air sisa atau

sisa-sisa buangan isi rumah.

Rujuk kepada ahli farmasi anda

cara-cara pelupusan ubat-ubatan

yang tidak diperlukan lagi.

Langkah-langkah ini akan

membantu melindungi alam

sekitar.

Maklumat lanjut

Rupa dan warna produk

Sirap ACTIFED dibekalkan

dalam botol 100ml.

Bahan-bahan kandungan

Bahan-bahan aktif

1.25 mg triprolidine

hydrochloride dan 30 mg

pseudoephedrine hydrochloride

dalam setiap 5 ml.

Bahan-bahan tidak aktif

Syrup, quinoline yellow E104,

purified water, glycerol, sodium

benzoate, sunset yellow E110,

sodium hydroxide, methyl

parahydroxybenzoate

Nombor MAL

MAL19860257ACZ

Pengilang

Aspen Bad Oldesloe GMBH

Industriestrasse 32-36,

23843, Bad Oldesloe,

Germany

Pemegang Pendaftaran

Produk

GlaxoSmithKline

Pharmaceutical Sdn. Bhd.

Level 6, Quill 9,

112 Jalan Semangat,

46300 Petaling Jaya,

Selangor, Malaysia

Tarikh kemaskini RiMUP

- 28/01/2016

Nombor siri

BPFK(R4/1)111115/00414

22-3-2019

Safety and efficacy of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species

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Published on: Thu, 21 Mar 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). O...

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Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

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Product defect correction - potentially damaged tablets

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1-2-2019

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

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Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

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1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

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Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-11-2018

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

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Update - medicine shortage

Therapeutic Goods Administration - Australia

18-3-2019

EU/3/16/1742 (Worphmed Srl)

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EU/3/16/1742 (Active substance: Acebutolol hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2157 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004715

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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

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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

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18-3-2019


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

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EU/3/06/349 (Vectura Ireland Limited)

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

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

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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

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

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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

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20-2-2019


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20-2-2019


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20-2-2019


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

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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

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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


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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