Adecure

Maklumat utama

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

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Adecure Syrup
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL09100270
  • 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)

ADECURE SYRUP

Methadone Hydrochloride (5mg/ml)

Apakah yang ada pada risalah ini

Apakah kegunaan Adecure Syrup

5mg/ml

Bagaimana

Adecure

Syrup

5mg/ml berfungsi

Sebelum menggunakan Adecure

Syrup 5mg/ml

Cara

menggunakan

Adecure

Syrup 5mg/ml

Semasa

menggunakan

Adecure

Syrup 5mg/ml

Kesan-kesan sampingan

Cara

penyimpanan

pelupusan

Adecure

Syrup

5mg/ml

Maklumat lanjut

Pengilang

Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan Adecure Syrup

5mg/ml

Methadone

Hydrochloride

adalah

kandungan

aktif

Adecure

Syrup

5mg/ml.

diindikasikan

untuk

rawatan

detoksifikasi atau rawatan pengekalan

penagihan narkotik.

Bagaimana Adecure Syrup 5mg/ml

berfungsi

Adecure

Syrup

mengandungi

Methadone

Hydrochloride

sebagai

bahan

aktif.

tergolong

dalam

kumpulan ubat-ubatan yang dipanggil

opioid.

Tanya

doktor

anda

jika

anda

mempunyai

sebarang

soalan

mengenai

mengapa

ubat

dipreskrib untuk anda. Doktor anda

mungkin mempreskrib ubat ini untuk

sebab yang lain.

Sebelum

menggunakan

Adecure

Syrup 5mg/ml

Bila tidak boleh menggunakan

Jika

anda

hipersensitif

terhadap

Methadone

Hydrochloride

atau

bahan-

bahan

lain

dalam

Adecure

Syrup 5mg/ml.

Jika

anda

mempunyai

depresi

respiratori

(pernafasan

yang

sangat

perlahan,

cetek),

penyakit

obstruktif

saluran

udara

(penyakit

paru-paru

atau

mana-mana

penyakit

yang

menyebabkan

kesukaran

bernafas),

kolitis

ulseratif

(radang gangguan usus) atau

fungsi

hati

terjejas

yang

teruk.

Jika anda sedang mengambil

atau telah mengambil dalam

minggu

yang

lepas,

ubat-ubatan

untuk

kemurungan

dikenali

sebagai Monoamine Oxidase

Inhibitors (MAIOs).

Jika

anda

menghadapi

serangan

asma

akut,

alkoholisme

akut

(mabuk

disebabkan

penggunaan

berlebihan minuman keras),

risiko

ileus

kelumpuhan

(sembelit

teruk

atau

sebarang halangan di dalam

usus)

atau

peningkatan

tekanan

intrakranial

(peningkatan

tekanan

sekitar otak) atau kecederaan

kepala.

Sebelum

menggunakan

Adecure

Syrup 5mg/ml

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

keadaan

asma

masalah

pernafasan.

Anda

mempunyai

kecederaan

kepala

peningkatan

tekanan

intrakranial.

Anda

mempunyai

masalah

kebimbangan.

Anda

perlu

memandu

atau

mengendalikan jentera.

Anda

mempunyai

penyakit

perut akut.

Anda

kebergantungan

kepada dadah yang lain.

Anda

mempunyai

penyakit

tekanan darah rendah.

Anda adalah pesakit tua atau

lemah.

Anda

menghadapi

kemerosotan buah pinggang

atau hati.

Anda

mempunyai

masalah

kelenjar tiroid atau kelenjar

pituitari.

Anda

mempunyai

masalah

prostat.

Anda

mempunyai

urethral

stricture

(penyempitan

saluran kencing).

Jika mengambil ubat-ubat lain

Sila

beritahu

doktor

atau

ahli

farmasi

anda

sekiranya

anda

sedang

mengambil

mana-mana

ubat beikut;

Depresan-depresan

sistem

saraf pusat yang lain seperti

narcotic

analgesics,

phenothiazines,

penenang

lain,

sedative-hyponotics,

tricyclic

antidepressants,

dan alkohol.

Pentazocine, ubat digunakan

untuk

merawat

kesakitan

jenis sederhana hingga serius,

termasuk

sebelum

pembedahan dan anesthesia.

Rifampin,

ubat

yang

digunakan

untuk

merawat

jangkitan.

Monoamine

Oxidase

Inhibitors

Naloxone, ubat-ubatan yang

digunakan

untuk

menterbalikkan

kesan-kesan

dadah

yang

digunakan

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

semasa

pembedahan

atau

untuk merawat kesakitan.

Naltrexone,

ubat

untuk

merawat

ketagihan

dadah

narkotik atau alcohol.

Antiviral,

ubat

untuk

merawat jangkitan virus.

Narcotic

antagonist

antagonist digunakan untuk

menyeimbangkan

kesan-

kesan narkotik (terutamanya

untuk

mengatasi

kemurungan pernafasan)

Sila

beritahu

doktor

atau

ahli

farmasi

anda

sekiranya

anda

sedang

mengambil

mana-mana

ubat,

termasuk

tonik

herba,

pelengkap

tambahan

ubat

yang dibeli tanpa preskripsi.

Cara menggunakan Adecure Syrup

5mg/ml

Adecure

Syrup

5mg/ml

hendaklah

diberikan

setiap

hari

bawah

pengawasan rapat.

Berapa banyak harus digunakan

Untuk rawatan detoksifikasi:

Dos permulaan ialah 15 hingga

20mg setiap hari.

Dos ini boleh diselaraskan oleh

doktor

bergantung

kepada

keadaan anda.

Jangan mengambil lebih daripada

dos yang disyorkan.

Tanya doktor atau ahli farmasi

anda

jika

anda

tidak

pasti

yang betul untuk anda. Mereka

akan memberitahu anda dengan

tepat

berapa

banyak

untuk

mengambil.

Adecure Syrup tidak digalakkan

untuk

digunakan

pada

kanak-

kanak.

Bagi pesakit-pesakit hamil:

Sila

berjumpa

dengan

doktor

sebelum

bermula

menggunakan

Adecure

Syrup

jika

anda

mengandung,

merancang

untuk

mengandung,

menyusukan

anak

atau

berniat

untuk

menyusukan

anak.

Doktor

anda

akan

menimbang

risiko

anda

mengambil

Adecure

Syrup

terhadap manfaat yang mungkin

berlaku terhadap anda.

Bila perlu digunakan

Ikut

arahan

doktor

atau

ahli

farmasi anda.

Berapa lama perlu digunakan

Jangan berhenti mengambil ubat

atau

menukar

tanpa

arahan daripada doktor anda.

Doktor

anda

mungkin

akan

mengurangkan jumlah yang anda

mengambil

dengan

beransur-

ansur

sebelum

berhenti

sepenuhnya untuk mengurangkan

kesan

sampingan

selepas

berhenti yang mungkin berlaku.

Jika terlupa mengunakan

Sekiranya anda terlupa satu

dos,

ambil

dengan

segera sebaik sahaja teringat.

Tetapi,

sekiranya

telah

hampir

masa

untuk

berikutnya,

abaikan

yang terlepas.

Jangan

mengambil

berganda

untuk

menggantikan

yang

dilupa.

Jika

mengambil

berlebihan

(terlebih dos)

Hubungi

doktor

anda

dengan

segera

atau

pergi

Jabatan

Kecemasan hospital terdekat, jika

anda atau sesiapa telah terambil

dos berlebihan.

perlu

dilakukan

walaupun

tiada sebarang kesan keracunan

atau

rasa

tidak

selesa.

Anda

mungkin

memerlukan

perhatian

perubatan segera.

Mengambil

terlalu

banyak

Adecure

Syrup

boleh

menyebabkan

Kesukaran bernafas

Somnolen

(mengantuk)

mungkin menjadi koma

Anak mata menjadi kecil

Kelembikan

pada

rangka

otot (kekurangan tonus otot)

Kulit sejuk dan lembap

Bradycardia (mengurangkan

kadar jantung)

Hypotension (tekanan darah

rendah)

Apnea (masalah pernafasan)

Kegagalan peredaran darah

Serangan jantung

Kematian

Semasa menggunakan Adecure

Syrup 5mg/ml

Perkara yang perlu dilakukan

Hubungi

doktor

sekiranya

simptom-simptom anda menjadi

lebih teruk atau tidak bertambah

baik.

Jika anda menjadi hamil semasa

mengambil

Adecure

Syrup

5mg/ml,

sila

beritahu

doktor

anda.

Perkara yang tidak boleh

dilakukan

Jangan

berikan

Adecure

Syrup

5mg/

kepada

orang

lain,

walaupun

mereka

mempunyai

simptom atau keadaan yang sama

seperti anda.

Doktor anda telah mempreskrib

Adecure

Syrup

5mg/ml

untuk

anda dan keadaan anda.

Perkara

yang

perlu

diberi

perhatian

Berhati-hati

semasa

memandu

atau

mengendalikan

jentera

sehingga

anda

tahu

bagaimana

Adecure

Syrup

5mg/ml

mempengaruhi anda.

Kesan-kesan sampingan

Seperti ubat-ubat lain, Adecure Syrup

5mg/ml mempunyai kesan sampingan

walaupun

bukan

semua

akan

mendapatnya.

Kesan-kesan

sampingan

berikut

mungkin

akan

terjadi dengan ubat ini:

KESAN

BAHAYA

UTAMA

METHADONE

ADALAH

DEPRESI

RESPIRATORI,

KEGAGALAN

PEREDARAN

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

DARAH,

KEJUTAN

PERNAFASAN DAN SERANGAN

JANTUNG.

Paling biasa: kepeningan, sedasi, loya,

muntah dan berpeluh.

Lain-lain:

Sistem saraf pusat: euforia (rasa

sangat gembira), disforia (sedih),

kelemahan,

sakit

kepala,

insomnia,

agitasi,

disorientasi,

gangguan

penglihatan,

tekanan

intrakranial meningkat.

Gastrointestinal (perut dan usus):

mulut

kering, anoreksia (hilang

selera

makan),

sembelit,

kekejangan saluran biliari.

Kardiovaskular:

muka

merah,

bradikardia

(kadar

jantung

perlahan),

palpitasi

(degupan

jantung secara tidak teratur, keras

atau

pantas),

rasa

pengsan,

syncope

(pengsan),

hipotensi

(tekanan darah rendah).

Genito-urinary:

retensi

atau

hesitancy

urinari,

kesan

antidiuretik (kurang pengeluaran

kencing),

mengurangkan

libido

(nafsu

seks)

dan/atau

potensi.

Alergi: pruritus (gatal), urtikaria

(sejenis ruam), ruam-ruam kulit

lain, edema (bengkak) dan jarang

urtikaria pendarahan (erupsi kulit

yang

dicirikan

dengan

pendarahan pada gelang).

Berbincang dengan doktor atau ahli

farmasi anda jika anda ragu-ragu atau

memerlukan maklumat lanjutan.

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.

Anda

boleh

melaporkan

sebarang

kesan sampingan atau kesan advers

terus

kepada

Pusat

Pemantauan

Kesan

Advers

Ubat

Kebangsaan

melalui No. Tel: 03-78835550, atau

laman

portal.bpfk.gov.my

(Consumers→Reporting)

Cara penyimpanan dan pelupusan

Adecure Syrup 5mg/ml

Penyimpanan

Jangan guna selepas tarikh tamat

tempoh

yang

dinyatakan

pada

bungkusan. Tarikh tamat tempoh

merujuk

kepada

hari

terakhir

bulan tersebut.

Adecure

Syrup

5mg/ml

perlu

disimpan dalam bekas tertutup di

bawah

suhu

25ºC.

Lindungi

daripada cahaya, kepanasan dan

kelembapan.

Jauhi dari kanak-kanak.

Pelupusan

Ubat-ubatan

tidak

seharusnya

dilupuskan melalui sisa air atau

sisa

rumah.

Tanya

ahli

farmasi anda cara-cara pelupusan

ubat-ubatan

yang

tidak

lagi

diperlukan. Langkah-langkah ini

akan membantu melindungi alam

sekitar.

Maklumat lanjut

Rupa dan warna produk

Sirap ini adalah cecair berwarna

merah.

Ia dibekalkan dalam botol plastik

Bahan-bahan Kandungan

Bahan aktif

Setiap ml sirap mengandungi

bahan

aktif,

Methadone Hydrochloride.

Bahan tidak aktif

Bahan-bahan kandungan lain

termasuklah

sodium citrate,

citric

acid

hydrous,

sodium benzoate, sucrose

suspension

grade,

ponceau

4R

propylene glycol.

Nombor MAL

MAL09100270AZ

Pengilang

dan

Pemegang

Pendaftaran Produk

Malaysian Pharmaceutical Industries

Sdn Bhd.

Plot 14, Lebuhraya Kampung Jawa,

11900 Bayan Lepas, Pulau Pinang,

Malaysia.

Tarikh kemaskini RiMUP

20/11/2015

Nombor Siri:

BPFK(R4/1)191115/00442

22-3-2019

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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