PIP-AMITRIPTYLINE

Main information

  • Trade name:
  • PIP-AMITRIPTYLINE amitriptyline hydrochloride 25mg tablet bottle pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PIP-AMITRIPTYLINE amitriptyline hydrochloride 25mg tablet bottle pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215348
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215348

PIP-AMITRIPTYLINE amitriptyline hydrochloride 25mg tablet bottle pack

ARTG entry for

Medicine Registered

Sponsor

Ipca Pharma (Australia) Pty Ltd

Postal Address

6 Morotai Avenue,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

22/08/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. PIP-AMITRIPTYLINE amitriptyline hydrochloride 25mg tablet bottle pack

Product Type

Single Medicine Product

Effective date

25/02/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of major depression. Amitriptyline 50 mg tablets are indicated only for the maintenance treatment of major depression ,Nocturnal

enuresis where organic pathology has been excluded.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

12 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. PIP-AMITRIPTYLINE amitriptyline hydrochloride 25mg tablet bottle pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Yellow colour, circular, biconvex, film coated tablets with 'IA' over '25'

debossed on one side and plain on the other side

Active Ingredients

amitriptyline hydrochloride

25 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 09:01:16 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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

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

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...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

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

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

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Worphmed Srl)

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

Europe -DG Health and Food Safety

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

15-3-2019

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

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

EU/3/06/349 (Active substance: Apomorphine hydrochloride (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)2115 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004495

Europe -DG Health and Food Safety

12-3-2019

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use (Active substance: nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequine) - Community Referrals - Art 31 - Commission Decision (2019)2050 of Tue, 12 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1452/C/2789

Europe -DG Health and Food Safety

11-3-2019


Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019

EU/3/16/1738 (F2G Biotech GmbH)

EU/3/16/1738 (F2G Biotech GmbH)

EU/3/16/1738 (Active substance: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide) - Transfer of orphan designation - Commission Decision (2019)1946 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004537

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1713 (F2G Biotech GmbH)

EU/3/16/1713 (F2G Biotech GmbH)

EU/3/16/1713 (Active substance: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide) - Transfer of orphan designation - Commission Decision (2019)1945 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004529

Europe -DG Health and Food Safety

8-3-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Europe - EMA - European Medicines Agency

6-3-2019


Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan), Treatment of granulomatosis with polyangiitis, 19/11/2014, Positive

Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan), Treatment of granulomatosis with polyangiitis, 19/11/2014, Positive

Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan), Treatment of granulomatosis with polyangiitis, 19/11/2014, Positive

Europe - EMA - European Medicines Agency

6-3-2019


Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide, Treatment of microscopic polyangiitis (avacopan), 19/11/2014, Positive

Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide, Treatment of microscopic polyangiitis (avacopan), 19/11/2014, Positive

Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide, Treatment of microscopic polyangiitis (avacopan), 19/11/2014, 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

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Domagrozumab, decision type: , therapeutic area: , PIP number: P/0327/2017

Opinion/decision on a Paediatric investigation plan (PIP): Domagrozumab, decision type: , therapeutic area: , PIP number: P/0327/2017

Opinion/decision on a Paediatric investigation plan (PIP): Domagrozumab, decision type: , therapeutic area: , PIP number: P/0327/2017

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface ant

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface ant

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B, decision type: , therapeutic area: , PIP number: P/208/2010

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)

Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)

Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066), decision type: , therapeutic area: , PIP number: P/0183/2014

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145)

Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145)

Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004), decision type: , therapeutic area: , PIP number: P/0210/2012

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Europe - EMA - European Medicines Agency

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

25-2-2019

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1619 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004220

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1620 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004218

Europe -DG Health and Food Safety

22-2-2019

Eurartesim (Alfasigma S.p.A.)

Eurartesim (Alfasigma S.p.A.)

Eurartesim (Active substance: piperaquine tetraphosphate/artenimol) - PSUSA - Modification - Commission Decision (2019)1579 of Fri, 22 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00001069/201804

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4 methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib), Treatment of neuroblastoma, 11/11/2015, Withdrawn

Orphan designation: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4 methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib), Treatment of neuroblastoma, 11/11/2015, Withdrawn

Orphan designation: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4 methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib), Treatment of neuroblastoma, 11/11/2015, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Prevymis,Letermovir, decision type: , therapeutic area: , PIP number: P/0385/2018

Opinion/decision on a Paediatric investigation plan (PIP): Prevymis,Letermovir, decision type: , therapeutic area: , PIP number: P/0385/2018

Opinion/decision on a Paediatric investigation plan (PIP): Prevymis,Letermovir, decision type: , therapeutic area: , PIP number: P/0385/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Peanut flour, decision type: , therapeutic area: , PIP number: P/0377/2018

Opinion/decision on a Paediatric investigation plan (PIP): Peanut flour, decision type: , therapeutic area: , PIP number: P/0377/2018

Opinion/decision on a Paediatric investigation plan (PIP): Peanut flour, decision type: , therapeutic area: , PIP number: P/0377/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate), decision type: , therapeutic area: , PIP number: P/0357/2018

Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate), decision type: , therapeutic area: , PIP number: P/0357/2018

Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate), decision type: , therapeutic area: , PIP number: P/0357/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab, decision type: , therapeutic area: , PIP number: P/0316/2014

Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab, decision type: , therapeutic area: , PIP number: P/0316/2014

Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab, decision type: , therapeutic area: , PIP number: P/0316/2014

Europe - EMA - European Medicines Agency

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): Taltz,ixekizumab, decision type: , therapeutic area: , PIP number: P/0352/2018

Opinion/decision on a Paediatric investigation plan (PIP): Taltz,ixekizumab, decision type: , therapeutic area: , PIP number: P/0352/2018

Opinion/decision on a Paediatric investigation plan (PIP): Taltz,ixekizumab, decision type: , therapeutic area: , PIP number: P/0352/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0356/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0356/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0356/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Orkambi,Lumacaftor,ivacaftor, decision type: , therapeutic area: , PIP number: P/0407/2018

Opinion/decision on a Paediatric investigation plan (PIP): Orkambi,Lumacaftor,ivacaftor, decision type: , therapeutic area: , PIP number: P/0407/2018

Opinion/decision on a Paediatric investigation plan (PIP): Orkambi,Lumacaftor,ivacaftor, decision type: , therapeutic area: , PIP number: P/0407/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cholera vaccine, live attenuated, oral (strain CVD 103-HgR), decision type: , therapeutic area: , PIP number: P/0381/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cholera vaccine, live attenuated, oral (strain CVD 103-HgR), decision type: , therapeutic area: , PIP number: P/0381/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cholera vaccine, live attenuated, oral (strain CVD 103-HgR), decision type: , therapeutic area: , PIP number: P/0381/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine, decision type: , therapeutic area: , PIP number: P/0402/2018

Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine, decision type: , therapeutic area: , PIP number: P/0402/2018

Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine, decision type: , therapeutic area: , PIP number: P/0402/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Forxiga,dapagliflozin, decision type: , therapeutic area: , PIP number: P/0373/2018

Opinion/decision on a Paediatric investigation plan (PIP): Forxiga,dapagliflozin, decision type: , therapeutic area: , PIP number: P/0373/2018

Opinion/decision on a Paediatric investigation plan (PIP): Forxiga,dapagliflozin, decision type: , therapeutic area: , PIP number: P/0373/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): lasmiditan, decision type: , therapeutic area: , PIP number: P/0358/2018

Opinion/decision on a Paediatric investigation plan (PIP): lasmiditan, decision type: , therapeutic area: , PIP number: P/0358/2018

Opinion/decision on a Paediatric investigation plan (PIP): lasmiditan, decision type: , therapeutic area: , PIP number: P/0358/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib, decision type: , therapeutic area: , PIP number: P/0394/2018

Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib, decision type: , therapeutic area: , PIP number: P/0394/2018

Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib, decision type: , therapeutic area: , PIP number: P/0394/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, decision type: , therapeutic area: , PIP number: P/0348/2018

Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, decision type: , therapeutic area: , PIP number: P/0348/2018

Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, decision type: , therapeutic area: , PIP number: P/0348/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, decision type: , therapeutic area: , PIP number: P/0349/2018

Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, decision type: , therapeutic area: , PIP number: P/0349/2018

Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, decision type: , therapeutic area: , PIP number: P/0349/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Xalkori,crizotinib, decision type: , therapeutic area: , PIP number: P/0361/2018

Opinion/decision on a Paediatric investigation plan (PIP): Xalkori,crizotinib, decision type: , therapeutic area: , PIP number: P/0361/2018

Opinion/decision on a Paediatric investigation plan (PIP): Xalkori,crizotinib, decision type: , therapeutic area: , PIP number: P/0361/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

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

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Liposomal combination of cytarabine and daunorubicin, decision type: , therapeutic area: , PIP number: P/0388/2018

Opinion/decision on a Paediatric investigation plan (PIP): Liposomal combination of cytarabine and daunorubicin, decision type: , therapeutic area: , PIP number: P/0388/2018

Opinion/decision on a Paediatric investigation plan (PIP): Liposomal combination of cytarabine and daunorubicin, decision type: , therapeutic area: , PIP number: P/0388/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), decision type: , therapeutic area: , PIP number: P/0360/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), decision type: , therapeutic area: , PIP number: P/0360/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), decision type: , therapeutic area: , PIP number: P/0360/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen,Naltrexone HCl,D-Sorbitol (PXT3003), decision type: , therapeutic area: , PIP number: P/0363/2018

Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen,Naltrexone HCl,D-Sorbitol (PXT3003), decision type: , therapeutic area: , PIP number: P/0363/2018

Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen,Naltrexone HCl,D-Sorbitol (PXT3003), decision type: , therapeutic area: , PIP number: P/0363/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surfa

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surfa

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc], decision type: , therapeutic area: , PIP number: P/0387/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine,dexamethasone (SHP640), decision type: , therapeutic area: , PIP number: P/0369/2018

Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine,dexamethasone (SHP640), decision type: , therapeutic area: , PIP number: P/0369/2018

Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine,dexamethasone (SHP640), decision type: , therapeutic area: , PIP number: P/0369/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0371/2018

Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0371/2018

Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0371/2018

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

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): 4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781), decision type: , therapeutic area: , PIP

Opinion/decision on a Paediatric investigation plan (PIP): 4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781), decision type: , therapeutic area: , PIP

Opinion/decision on a Paediatric investigation plan (PIP): 4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781), decision type: , therapeutic area: , PIP number: P/0366/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro,Ixazomib, decision type: , therapeutic area: , PIP number: P/0376/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro,Ixazomib, decision type: , therapeutic area: , PIP number: P/0376/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro,Ixazomib, decision type: , therapeutic area: , PIP number: P/0376/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lenvima,Lenvatinib, decision type: , therapeutic area: , PIP number: P/0389/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lenvima,Lenvatinib, decision type: , therapeutic area: , PIP number: P/0389/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lenvima,Lenvatinib, decision type: , therapeutic area: , PIP number: P/0389/2018

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, decision type: , therapeutic area: , PIP number: P/0378/2018

Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, decision type: , therapeutic area: , PIP number: P/0378/2018

Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, decision type: , therapeutic area: , PIP number: P/0378/2018

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cimzia,Certolizumab pegol, decision type: , therapeutic area: , PIP number: P/0397/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cimzia,Certolizumab pegol, decision type: , therapeutic area: , PIP number: P/0397/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cimzia,Certolizumab pegol, decision type: , therapeutic area: , PIP number: P/0397/2018

Europe - EMA - European Medicines Agency