ALFAGLANDIN

Main information

  • Trade name:
  • Alfaglandin C 0.250 mg/ml Solution for Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Alfaglandin C 0.250 mg/ml Solution for Injection
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cloprostenol
  • Therapeutic area:
  • Cattle Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0146/001
  • Authorization date:
  • 24-03-2010
  • EU code:
  • NL/V/0146/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALFAGLANDINC0.250mg/mlsolutionforinjectionforcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perml:

Activesubstance:

Eachmlsolutioncontains0.250mgcloprostenol(ascloprostenolsodium)

Excipient(s):

Chlorocresol1mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

4.2 Indicationsforuse,specifyingthetargetspecies

Pyometra

Suboestrus

Oestrussynchronisation

Terminationofabnormalpregnancyincattleuptoday150ofthepregnancy(forabnormal

pregnancy)

Ovarianlutealcysts

Inductionofparturition

4.3 Contraindications

Donotadministertopregnantanimalsunlesstheobjectiveistoterminategestationortoinduce

parturition.

4.4 Specialwarningsforeachtargetspecies

Arefractoryperiodof4to5daysafterovulatinghastobetakenintoaccountduringwhichcattlewill

notbesensitivetotheluteolyticeffectsofprostaglandins.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Administerbyintramuscularinjectionobservingtheusualasepticprecautions.

Careshouldbetakentoavoidinjectionthroughwetordirtyareasofskin.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

- ProstaglandinsoftheF

2α typecanbeabsorbedthroughtheskinandmaycausebronchospasm

ormiscarriage.

- Directcontactwiththeskinoreyesmaycauseirritationandallergicreactions.

- Theproductshouldnotbeadministeredbypregnantwomenorwomenwhoareintendingto

becomepregnant.

- Peoplewithaknownhypersensitivitytocloprostenolorchlorocresolshouldavoidcontact

withtheveterinarymedicinalproduct.

- Thisproductcanbeabsorbedthroughtheskinandthereforecareshouldbetakenwhen

handlingtheproduct,especiallybywomenofchild-bearingpotential,asthmaticsandpeople

withbronchialandotherrespiratoryproblems.

- Avoiddirectcontactwiththeskinandeyes.

- Avoidaccidentalself-injection

- Weargloves.

- Accidentalspillageontheskinorintotheeyesshouldbewashedoffimmediatelywithplenty

ofwater.

- Incaseofaccidentalself-injectionorrespiratoryproblems,seekmedicaladviceimmediately

andshowthepackageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Localisedpost-injectionbacterialinfections,whichmaybecomegeneralised,areoccasionallyreported.

4.7 Useduringpregnancy,lactationorlay

Donotadministerduringpregnancy,iftheobjectiveisnottoinduceterminationofanabnormal

gestationortoinduceparturition.

Theproducthasnonegativeinfluenceonfertility.Nonegativeeffectsonoffspringhavebeen

reportedafterinseminationornaturalserviceaftertreatmentwithcloprostenol.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Simultaneoususeofoxytocinandcloprostenolincreasestheeffectoncontractilityofthemusculature

oftheuterus.

4.9 Amountstobeadministeredandadministrationroute

Byintramuscularinjection:0.5mg(2ml)cloprostenolperanimal.

Oestrussynchronisation:twoinjectionswith11daysinterval.

Terminationofabnormalpregnancy:betweenday5and150afterinsemination.

Inductionofparturition:within10daysbeforetheexpecteddateofparturition.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproducthasawidesafetymargin.Thereisnoantidoteavailable.

4.11 Withdrawalperiod(s)

Milk:0days.

Meat:1day.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Prostaglandins

ATCvetcode:QG02AD90

5.1 Pharmacodynamicproperties

CloprostenolisasyntheticprostaglandinanaloguestructurallyrelatedtoProstaglandinF2α.

Itisapotentluteolyticagentforuseincattle.Cloprostenolcausesfunctionalandmorphological

regressionofthecorpusluteum(luteolysis)followedbyreturntooestrusandnormalovulation.

5.2 Pharmacokineticparticulars

Afterintramuscularinjectionsoftheproductincowsthefollowingpharmacokineticparameterswere

found:aCmaxat16min.andaT1/2of44min.Theseparametersindicatearapidabsorptionfromthe

injectionsiteandalsoarapidelimination.Afterintramuscularadministrationof0.5mgand10mg

(C14)cloprostenoltocowstheexcretionbyurinewas58%and56%ofthedosesrespectively.

Unchangedcloprostenolandtetranoracidwerethemainmetabolitesfoundintheurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumchloride

Sodiumcitrate

Citricacid

Chlorocresol

Sodiumhydroxide(forpHadjustment)

Waterforinjections

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

Incompatiblewithstrongacidic/alkalineproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4. Specialprecautionsforstorage

Protectfromlight.Donotfreeze.Protectfromfrost.

Storeinarefrigerator(2

C–8

C)afterfirstopeningtheimmediatepackaging.

6.4 Natureandcompositionofimmediatepackaging

Amberglass,20ml,typeIIvialwithbromobutylrubberstopperandaluminiumclosure.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

P.O.Box78

3440ABWoerden

TheNetherlands

Tel.:0031-348416945

Fax0031-348483676

e-mail:a lfasan@wxs.nl

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

LABELLINGANDPACKAGELEAFLET

A.LABELLING

>

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

POLYSTYRENEBOX

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALFAGLANDINC0.250mg/mlsolutionforinjectionforcattle.

Cloprostenolsodium

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlsolutioncontains0.250mgcloprostenol(ascloprostenolsodium)

Excipient(s):chlorocresol1mg/ml

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

28vialsx20ml.

5. TARGETSPECIES

Cattle.

6. INDICATION(S)

Pyometra

Suboestrus

Oestrussynchronisation

Terminationofabnormalpregnancyincattleuptoday150ofthepregnancy(forabnormal

pregnancy)

Ovarianlutealcysts

Inductionofparturition

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscular.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Milk:0days.

Meat:1day.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

Administerbyintramuscularinjectionobservingtheusualasepticprecautions.

Careshouldbetakentoavoidinjectionthroughwetordirtyareasofskin.

UserWarnings

-ProstaglandinsoftheF

2α typecanbeabsorbedthroughtheskinandmaycausebronchospasmor

miscarriage.

-Directcontactwiththeskinoreyesmaycauseirritationandallergicreactions.

-Theproductshouldnotbeadministeredbypregnantwomenorwomenwhoareintendingtobecome

pregnant.

-Peoplewithaknownhypersensitivitytocloprostenolorchlorocresolshouldavoidcontactwiththe

veterinarymedicinalproduct.

-Thisproductcanbeabsorbedthroughtheskinandthereforecareshouldbetakenwhenhandlingthe

product,especiallybywomenofchild-bearingpotential,asthmaticsandpeoplewithbronchialand

otherrespiratoryproblems.

-Avoiddirectcontactwiththeskinandeyes.

-Avoidaccidentalself-injection

-Weargloves.

-Accidentalspillageontheskinorintotheeyesshouldbewashedoffimmediatelywithplentyof

water.

-Incaseofaccidentalself-injectionorrespiratoryproblems,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.

10. EXPIRYDATE

EXP{month/year}Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

11. SPECIALSTORAGECONDITIONS

Protectfromlight.Donotfreeze.Protectfromfrost.

Storeinarefrigerator(2

C–8

C)afterfirstopeningtheimmediatepackaging.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithnationalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription-

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

P.O.Box78

3440ABWoerden

TheNetherlands

Tel.:0031-348416945

Fax0031-348483676

e-mail: Alfasan@wxs.nl

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

GLASSVIAL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALFAGLANDINC0.250mg/mlsolutionforinjectionforcattle

Cloprostenolsodium

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Eachmlsolutioncontains0.250mgcloprostenol(ascloprostenolsodium)

Excipient(s):Chlorocresol1mg/ml

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

20mlsolutionforinjection

4. ROUTE(S)OFADMINISTRATION

Intramuscular.

5. WITHDRAWALPERIOD

Milk:0days.

Meat:1day.

6. BATCHNUMBER

Batch:

7. EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

AlfaglandinC0.250mg/ml,solutionforinjectionforcattle

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE

Marketingauthorisationholderandmanufacturer

AlfasanNederlandBV

P.O.Box78

3440ABWoerden

TheNetherlands

Tel.:0031-348416945

Fax0031-348483676

e-mail: alfasan@wxs.nl

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AlfaglandinC0.250mg/ml,solutionforinjectionforcattle

Cloprostenolsodium

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlsolutioncontains0.250mgcloprostenol(ascloprostenolsodium).

Excipient(s):Chlorocresol1mg/ml

4. INDICATION(S)

Pyometra

Suboestrus

Oestrussynchronisation

Terminationofabnormalpregnancyincattleuptoday150ofthepregnancy(forabnormal

pregnancy)

Ovarianlutealcysts

Inductionofparturition

5. CONTRAINDICATIONS

Donotadministertopregnantanimalsunlesstheobjectiveistoterminateanabnormalgestationorto

induceparturition.

6. ADVERSEREACTIONS

Localisedpost-injectionbacterialinfections,whichmaybecomegeneralised,areoccasionallyreported.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cattle.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Byintramuscularinjection:0.5mg(2ml)cloprostenolperanimal.

Oestrussynchronisation:twoinjectionswith11daysinterval.

Terminationofabnormalpregnancy:betweenday5and150afterinsemination.

Inductionofparturition:within10daysbeforetheexpecteddateofparturition.

9. ADVICEONCORRECTADMINISTRATION

Weargloves.

10. WITHDRAWALPERIOD

Milk:0days.

Meat:1day.

11. SPECIALSTORAGEPRECAUTIONS

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Protectfromlight.Donotfreeze.Protectfromfrost.

Storeinarefrigerator(2

C–8

C)afterfirstopeningtheimmediatepackaging.

Donotuseaftertheexpirydatestatedonthelabel/carton.

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Donotmixwithanyotherveterinarymedicinalproduct.

Incompatiblewithstrongacidic/alkalineproducts.

Arefractoryperiodof4to5daysafterovulatinghastobetakenintoaccountduringwhichcattlewill

notbesensitivetotheluteolyticeffectsofprostaglandins.

Simultaneoususeofoxytocinandcloprostenolincreasestheeffectsoncontractilityofthemusculature

oftheuterus.

Donotadministertopregnantanimalsunlesstheobjectiveistoterminateanabnormalgestationorto

induceparturition.

Administerbyintramuscularinjectionobservingtheusualasepticprecautions.

Careshouldbetakentoavoidinjectionthroughwetordirtyareasofskin.

UserWarnings

-ProstaglandinsoftheF

2α typecanbeabsorbedthroughtheskinandmaycausebronchospasmor

miscarriage.

-Directcontactwiththeskinoreyesmaycauseirritationandallergicreactions.

-Theproductshouldnotbeadministeredbypregnantwomenorwomenwhoareintendingtobecome

pregnant.

-Peoplewithaknownhypersensitivitytocloprostenolorchlorocresolshouldavoidcontactwiththe

veterinarymedicinalproduct.

-Thisproductcanbeabsorbedthroughtheskinandthereforecareshouldbetakenwhenhandlingthe

product,especiallybywomenofchild-bearingpotential,asthmaticsandpeoplewithbronchialand

otherrespiratoryproblems.

-Avoiddirectcontactwiththeskinandeyes.

-Avoidaccidentalself-injection

-Weargloves.

-Accidentalspillageontheskinorintotheeyesshouldbewashedoffimmediatelywithplentyof

water.

-Incaseofaccidentalself-injectionorrespiratoryproblems,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithnationalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Packaging:polystyreneboxcontaining28x20mlvials.

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AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

Europe - EMA - European Medicines Agency

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

FDA - U.S. Food and Drug Administration

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

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 (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

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 (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

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 (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety