Allavin

Maklumat utama

  • Nama dagangan:
  • Allavin Plus Expectorant
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Allavin Plus Expectorant
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL05012316
  • Kemaskini terakhir:
  • 31-08-2017

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

ALLAVIN PLUS EXPECTORANT

Diphenhydramine hydrochloride/Ammonium chloride/Pseudoephedrine hydrochloride (14mg/135mg/30mg per 5ml)

1

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Apakah yang ada pada risalah ini

Apakah kegunaan Allavin Plus

Expectorant

Bagaimana Allavin Plus Expectorant

berfungsi

Sebelum menggunakan Allavin Plus

Expectorant

Cara menggunakan Allavin Plus

Expectorant

Semasa menggunakan Allavin Plus

Expectorant

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Allavin Plus Expectorant

Maklumat lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah

kegunaan

Allavin

Plus

Expectorant

Allavin

Plus

Expectorant

digunakan

untuk

menghilangkan

batuk

yang

berkahak dengan hidung tersumbat.

Bagaimana Allavin Plus Expectorant

berfungsi

Diphenhydramine

hydrochloride

berfungsi

dengan

menyekat

bahan

semulajadi

badan

(histamina)

yang

dihasilkan

semasa

tindak

balas

alergik/alahan.

Kesan

pengeringan

atas simptom-simptom mata dan hidung

berair

adalah

disebabkan

oleh

penyekatan satu lagi bahan semulajadi

badan (

acetylcholine

Ammonium chloride

adalah ekspektoran

yang

bertindak

dengan

merangsang

mukosa

bronkial

(saluran

udara).

menyebabkan

penghasilan

rembesan

yang

berlebihan

dalam

saluran

pernafasan dan mengurangkan kelikatan

kahak

yang

mungkin

memudahkan

kahak dibatuk keluar.

Pseudoephedrine

hydrochloride

berfungsi

dengan

mengecutkan

saluran

darah di kawasan sinus di dalam hidung,

mengurangkan

kebengkakan

sinus

memudahkan pernafasan.

Sebelum menggunakan Allavin Plus

Expectorant

Bila tidak boleh menggunakan

Jangan

mengambil

Allavin

Plus

Expectorant sekiranya anda:

alergik/alah kepada sebarang ubat-

ubatan

yang

mengandungi

diphenhydramine,

pseudoephedrine

atau

ammonium chloride

penyakit jantung termasuk penyakit

jantung

iskemia

(pengurangan

bekalan darah ke jantung), penyakit

arteri

koronari

(gangguan

bekalan

darah

jantung

disebabkan

oleh

obstruksi saluran darah) dan tekanan

darah tinggi.

Mengandung dan menyusukan bayi

Jangan

mengambil

ubat

sekiranya

anda hamil, atau merancang untuk hamil

atau anda rasa anda telah hamil.

Ubat

akan

dirembeskan

dalam

susu

ibu.

Penggunaan

oleh

yang

menyusukan

bayi

adalah

tidak

digalakkan.

Dapatkan

nasihat

daripada

doktor atau ahli farmasi anda sebelum

mengambil ubat ini.

Jangan

mengambil

ubat

selepas

tarikh

luputnya

seperti

tertulis

pada

bungkusannya atau sekiranya bungkusan

sudah

koyak

atau

tanda

sudah

dibuka.

Sekiranya

sudah

tamat

tempoh

atau

rosak, kembalikan pada ahli farmasi anda

untuk dilupuskan.

Sekiranya anda tidak pasti sama ada anda

harus

mengambil

ubat

ini,

bincang

dengan ahli farmasi atau doktor anda.

Sebelum mula menggunakan Allavin

Plus Expectorant

Beritahu doktor atau ahli farmasi anda

sekiranya

anda

alergi/alahan

terhadap sebarang ubat, makanan, bahan

pengawet atau pewarna.

Jika

anda

sensitif

kepada

sympathomimetics

seperti

albuterol,

amfetamin

,

ephedrine,

terbutaline

epinerphine,

anda

mungkin

sensitif

kepada ubat ini juga.

Jangan

berikan

ubat

kepada

bayi

pramatang atau bayi yang baru lahir .

Jangan

gunakan

ubat

pada

kanak-

kanak di bawah 2 tahun.

Ubat ini perlu digunakan dengan berhati-

hati

atas

nasihat

doktor

atau

ahli

farmasi untuk kanak-kanak 2 hingga 6

tahun.

Bagi warga tua, sila beritahu doktor anda

jika anda mempunyai hipertrofi prostat

(pembesaran kelenjar prostat).

Jika mengambil ubat-ubat lain

Beritahu ahli farmasi anda ubat-ubatan

yang anda beli termasuk ubat yang dibeli

tanpa preskripsi dari farmasi, pasaraya,

atau kedai makanan kesihatan.

Allavin

Plus

Expectorant

ubat-

ubatan

lain

boleh

mengganggu

antara

satu sama lain. Ini termasuk:

ubat atau bahan yang merencatkan

sistem

saraf

pusat

seperti

alkohol,

barbiturat,

hipnotik, sedatif dan ubat

penenang

ubat yang digunakan untuk merawat

tekanan darah tinggi seperti perencat

beta

ubat

yang

digunakan

untuk

melegakan kesakitan seperti

cocaine

monoamine oxidase inhibitors

(ubat

yang

digunakan

untuk

merawat

kemurungan)

seperti

furazolidone,

procarbazine,selegiline.

Ubat ini tidak boleh diambil semasa

atau dalam tempoh 14 hari selepas

rawatan dengan MAOIs

Ubat

boleh

mengganggu

kesan

Allavin

Plus

Expectorant

atau

mempengaruhi bagaimana ia bertindak.

2

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Doktor

atau

ahli

farmasi

anda

mempunyai

maklumat

tentang

ubat-

ubatan yang perlu diambil perhatian atau

dielakkan semasa mengambil ubat ini.

Cara menggunakan Allavin Plus

Expectorant

Ikuti dengan berhati-hati segala arahan

yang

diberikan

oleh

ahli

farmasi

atau

doktor anda. Arahan tersebut mungkin

berbeza

daripada

maklumat

dalam

risalah ini.

Sekiranya anda tidak memahami arahan

yang bertulis pada label botol, bertanya

kepada

ahli

farmasi,

jururawat

atau

doktor anda untuk menerangkan kepada

anda arahan tersebut.

Berapa banyak harus digunakan

Dos dewasa dan kanak-kanak lebih 12

tahun

10ml tiga kali sehari.

Dos kanak-kanak 4-12 tahun

2.5ml hingga 5ml tiga kali sehari.

Bagi kanak-kanak berumur 2-3 tahun

Seperti yang diarahkan oleh doktor

Bila perlu digunakan

Ubat ini perlu diambil tiga kali sehari

jika perlu.

Ikut

arahan

doktor

atau

ahli

farmasi

anda.

Berapa lama perlu digunakan

Ubat

batuk

selesema

biasanya

diambil untuk jangka masa yang singkat

sahaja sehingga simptom anda hilang.

Teruskan

penggunaan

Allavin

Plus

Expectorant

untuk

tempoh

masa

yang

ditetapkan oleh doktor anda.

Jika terlupa menggunakan

Sekiranya anda mengambil ubat ini pada

masa

yang

tetap

anda

terlupa

mengambil

satu

dos,

ambillah

dengan segera sebaik sahaja teringat.

Walau

bagaimanapun,

jika

sudah

menghampiri

waktu

untuk

berikutnya,

biarkan

sahaja

yang

terlupa

tadi

teruskan

dengan

yang

berikutnya

mengikut

jadual

pengambilan ubat. Jangan gandakan dos

untuk

menggantikan

yang

terlupa

diambil.

Jika mengambil berlebihan (terlebih

dos)

Dapatkan

pemeriksaan

perubatan

sekiranya anda telah terlebih mengambil

ubat ini.

Bagi

bayi

kanak-kanak,

kesan

perangsang sistem saraf pusat melebihi

kesan

perencat

sistem

saraf

pusat,

menyebabkan

ataksia

(gangguan

koordinasi

pergerakan),

keterujaan,

terketar-ketar, psikosis (penyakit mental

yang

menyebabkan

kehilangan

perhubungan

dengan

realiti),

khayalan,

konvulsi (sawan) dan suhu badan yang

sangat tinggi. Koma yang berpanjangan

kegagalan

sistem

kardiorespiratori

(pemberhentian fungsi jantung dan paru-

paru

secara

tiba-tiba)

juga

mungkin

menyusul.

Bagi orang dewasa, depresi sistem saraf

pusat

lebih

biasa

berlaku

iaitu

mengantuk,

koma

konvulsi

yang

boleh

membawa

kepada

kegagalan

pernafasan

atau

kegagalan

sistem

kardiovaskular

(pemberhentian

fungsi

jantung secara tiba-tiba).

Ammonium

chloride

pada

yang

tinggi

boleh

menyebabkan

asidosis

(peningkatan keasidan dalam darah dan

tisu badan yang lain) dan hipokalemia

(tahap

kalium

yang

rendah

daripada

normal).

Semasa menggunakan Allavin Plus

Expectorant

Perkara yang perlu dilakukan

Beritahu ahli farmasi dan doktor anda

sekiranya simptom anda tidak bertambah

baik. Ahli farmasi atau doktor anda akan

memeriksa

keadaan

anda

akan

memberitahu

sama

anda

perlu

meneruskan atau tidak pengambilan ubat

ini.

Beritahu

doktor,

doktor

gigi

ahli

farmasi

anda

bahawa

anda

sedang

mengambil Allavin Plus Expectorant.

Beritahu

doktor

anda

dengan

segera

sekiranya anda hamil semasa mengambil

ubat ini.

Perkara yang tidak boleh dilakukan

Elakkan

minuman

beralkohol.

akan

meningkatkan kesan sampingan ubat ini.

Jangan membeli atau menggunakan ubat-

ubat lain untuk merawat masalah batuk,

selsema atau alergi/alahan tanpa bertanya

kepada

ahli

farmasi

atau

doktor

anda

terlebih

dahulu.

Jika

anda

mengambil

sesetengah

ubat

bersama-sama,

anda

berkemungkinan

mengambil

terlalu

banyak ubat yang sama. Baca label ubat

lain

yang

anda

gunakan

untuk

memastikan

sama

ianya

mengandungi

diphenhydramine,

pseudoephedrine

atau

ammonium

chloride

Jangan

mengambil

ubat

untuk

merawat masalah lain kecuali atas arahan

ahli farmasi atau doktor anda.

Jangan

beri

ubat

kepada

orang

lain

walaupun

mereka

mengalami

masalah

yang sama seperti anda.

Jangan

mengambil

lebih

daripada

yang disarankan kecuali atas arahan ahli

farmasi atau doktor anda.

Perkara yang perlu diberi perhatian

Allavin

Plus

Expectorant

boleh

menyebabkan

kesan

sampingan

yang

boleh mengganggu cara anda berfikir dan

bertindak.

Berhati-hati

sekiranya

anda

memandu,

mengendalikan

jentera

atau

melakukan

aktiviti

yang

memerlukan

kewaspadaan.

Elakkan minuman beralkohol. Ini boleh

meningkatkan

sesetengah

kesan

sampingan

daripada

Allavin

Plus

Expectorant.

3

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Kesan-kesan sampingan

Beritahu doktor atau ahli farmasi anda

sekiranya anda berasa tidak sihat semasa

mengambil

Allavin

Plus

Expectorant.

Ubat

membantu

kebanyakan

orang

tetapi

juga

mempunyai

kesan

sampingan pada sesetengah orang.

Kadang-kadang ianya serius dan kadang-

kadang

ianya

tidak.

Anda

mungkin

memerlukan

perhatian

perubatan

sekiranya anda mengalami kesan-kesan

sampingan tersebut.

Jangan

bimbang

dengan

senarai

kesan

sampingan berikut. Anda mungkin tidak

akan mengalaminya. Bertanyalah dengan

doktor dan ahli farmasi anda jika anda

mempunyai sebarang persoalan.

Hubungi doktor atau ahli farmasi anda

sekiranya

anda

mengalami

kesan

sampingan

berikut

ianya

membimbangkan anda:

kekurangan tenaga

mengantuk

pening

berkordinasi

mulut kering

penebalan mukus

sesak dada

penglihatan kabur

kesukaran atau sakit semasa kencing

sembelit

peningkatan kemasukan gastrik

kadar jantung yang luar biasa cepat

atau kadar jantung yang tidak teratur

ketakutan, kegelisahan

masalah untuk tidur

Kesemua

kesan

sampingan

tersebut

boleh

disebabkan

oleh

mana-mana

antihistamina

pseudoephedrine

Garam

ammonium

akan

merengsa

lapisan mukosa perut dan membuatkan

anda merasa mual dan muntah sekiranya

diambil dalam dos yang besar.

bukanlah

senarai

lengkap

kesan-

kesan sampingan.

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

Allavin Plus Expectorant

Penyimpanan

Simpan ubat ini di tempat yang sejuk dan

kering

mana

suhunya

sentiasa

bawah 30°C. Lindungi daripada cahaya.

Pastikan semua ubat tidak dapat dilihat

dan dicapai oleh kanak-kanak

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

dapat

membantu melindungi alam sekitar.

Maklumat lanjut

Rupa dan warna produk

Sirap berperisa dan berwarna merah.

Bahan-bahan kandungan

Bahan-bahan aktif

Setiap 5ml mengandungi

Ammonium

chloride

135mg,

Diphenhydramine

hydrochloride

14mg

Pseudoephedrine

hydrochloride

30mg.

Bahan-bahan tidak aktif

Chloroform spirit

Liquid glucose

Cherry red carmoisine

Strawberry flavour

Blackcurrant flavour

Sugar

Methylparaben

Propylparaben

Trisodium citrate

Menthol

Propylene Glycol

Deionised water

Saccharin sodium

Nombor MAL

MAL05012316AC

Pengilang

UPHA

PHARMACEUTICAL

MFG.

(M) SDN BHD (53667-M)

Lot 2&4, Jalan P/7, Section 13,

Bangi Industrial Estate,

43650 Bandar Baru Bangi,

Selangor Darul Ehsan.

Pemegang Pendaftaran Produk

PHARMACEUTICALS

BHD (277454-W)

Lot 2&4, Jalan P/7, Section 13,

Bangi Industrial Estate,

43650 Bandar Baru Bangi,

Selangor Darul Ehsan.

Tarikh kemaskini RiMUP

26/01/2016

Nombor siri

BPFK(R4/1)031115/00394

7-3-2019

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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


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): 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

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety