Cyanocobalamin 50microgram tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Cyanocobalamin
Available from:
Alliance Healthcare (Distribution) Ltd
ATC code:
B03BA01
INN (International Name):
Cyanocobalamin
Dosage:
50microgram
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 09010200

Read the complete document

Cyanocobalamin

50 micrograms Tablets

Vitamin B

50 Tablets

P

Each film coated tablet contains

50 micrograms cyanocobalamin.

Also contains lactose.

See leaflet for further information.

To be taken by mouth.

Use as directed by your doctor.

Dosage: Adults and Elderly -

Usual dose is 1 to 3 tablets or

more, daily between meals.

Children: Usual dose is 1 tablet.

Keep out of the sight and reach

of children.

Do not store above 25°C.

Store in the original container in

order to protect from light.

Keep the container tightly closed.

Marketing Authorisation Holder:

Mercury Pharma Group Ltd.,

Capital House,

85 King William Street,

London EC4N 7BL, UK

PL 10972/0028

LL-117965-01

50

micrograms

Cyanocobalamin

50 micrograms Tablets

Vitamin B

50 Tablets

P

Each film coated tablet contains

50 micrograms cyanocobalamin.

Also contains lactose.

See leaflet for further information.

To be taken by mouth.

Use as directed by your doctor.

Dosage: Adults and Elderly - Usual

dose is 1 to 3 tablets or more, daily

between meals.

Children: Usual dose is 1 tablet.

Keep out of the sight and reach of

children.

Do not store above 25°C.

Store in the original container in

order to protect from light.

Keep the container tightly closed.

Marketing Authorisation Holder:

Mercury Pharma Group Ltd.,

Capital House,

85 King William Street,

London EC4N 7BL, UK

PL 10972/0028

LL-117965-01

11001620

50

micrograms

B.No :

Exp :

Pregnancy, breast feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning

to have a baby, ask your doctor or pharmacist for advice before taking this

medicine.

As with all drugs Cyanocobalamin Tablets should only be given in pregnancy

and when breast feeding if absolutely necessary.

Cyanocobalamin Tablets contains lactose

This medicine also contains lactose (which is a sugar). If you have been told by your

doctor that you have an intolerance to some sugars, contact your doctor before taking

this medicinal product.

3. How to take Cyanocobalamin Tablets

Always take this medicine exactly as described in this leaflet or as your doctor

or pharmacist has told you. Check with your doctor or pharmacist if you are not

sure.

Please read the label carefully, it will tell you how many Cyanocobalamin Tablets

to take each day.

The recommended dose is:

Adults and Elderly: one to three tablets daily.

Children: one tablet daily.

Cyanocobalamin Tablets should be swallowed with water and taken between

meals. Do not stop taking this medicine, except on your doctor’s advice. Your

doctor may change the dose, depending on how you react to it.

If you take more Cyanocobalamin Tablets than you should:

If you accidentally take too much of this medicine, bring any remaining tablets

and this leaflet with you to your doctor or pharmacist so that they know exactly

what you have taken.

If you forget to take Cyanocobalamin Tablets:

If you miss a dose, take it as soon as you remember, if it is within a few hours

of the normal time. Otherwise, leave out that dose completely and take your next

dose at the normal time it is due.

Do not take a double dose to make up for forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

Allergic reactions to these tablets are rare but may show as an itchy rash. Very

rarely, a severe allergic reaction may occur causing sudden onset of swelling of

the face and neck, and shortness of breath.

Acne-like and blister rashes have been reported rarely.

If any of the side effects become serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report

side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or

search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cyanocobalamin Tablets

Keep this medicine out of the sight and reach of children.

Do not use Cyanocobalamin Tablets after the expiry date which is stated on label.

The expiry date refers to the last day of that month. If your medicine is out of date,

take it to your pharmacist who will get rid of it safely.

Do not store above 25°C (room temperature). Store in the original container/package.

Protect from light.

6. Contents of the pack and other Information

What Cyanocobalamin tablets contains

The active substance is cyanocobalamin. Each film coated tablet contains 50

micrograms cyanocobalamin.

Cyanocobalamin Tablets also contains lactose, maize starch, magnesium stearate

and purified water. The film coating includes hydroxypropyl methylcellulose,

ethylcellulose, acetylated monoglyceride, speed colour white 27120 anstead HSE,

isopropyl alcohol and dichloromethane.

What Cyanocobalamin Tablets looks like and contents of pack

The tablets are engraved ‘Cytacon’ on one face and plain on the reverse.

Cyanocobalamin Tablets are available in container packs of 50 and 100 tablets and

blister packs of 28, 56 and 112 tablets (Not all pack sizes may be marketed).

Marketing authorisation holder

Mercury Pharma Group Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer

Recipharm Limited, Vale of Bardsley, Ashton under-Lyne, Lancashire OL7 9RR,

United Kingdom

This leaflet was last revised in April 2019.

LL-117965-01

Read all of this leaflet carefully before you start using this medicine because it

contains important information for you.

This medicine is available without prescription. However, you still need to take

Cyanocobalamin Tablets carefully to get the best results from it.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need

more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel worse

The name of your medicine is Cyanocobalamin 50 micrograms Tablets.

It will be referred to as Cyanocobalamin Tablets for ease of use hereafter.

What is in this leaflet:

1. What Cyanocobalamin Tablets are and what they are used for

2. What you need to know before you take Cyanocobalamin Tablets

3. How to take Cyanocobalamin Tablets

4. Possible side effects

5. How to store Cyanocobalamin Tablets

6. Contents of the pack and other information

1. What Cyanocobalamin Tablets are and what they are used for

Cyanocobalamin Tablets contain cyanocobalamin,which is known as vitamin B

Most people get enough vitamin B

from their food, but if you have had

stomach surgery, or certain diseases of the intestines, or a restricted diet, you

may not absorb enough vitamin B

Lack of vitamin B

in the body causes a disease called pernicious anaemia (reduction

in the number of red blood cells) which is often treated with vitamin B

injections.

Cyanocobalamin tablets are used to treat vitamin B

deficiency when injections

cannot be used.

2. What you need to know before you take Cyanocobalamin Tablets

DO NOT take Cyanocobalamin Tablets :

if you are allergic to cyanocobalamin or any of the other ingredients of this

medicine (listed in section 6 ).

Those who have an allergic reaction to Cyanocobalamin by injection are often

able to take Cyanocobalamin Tablets without problems.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Cyanocobalamin Tablets

If you have any other medical conditions, speak to your doctor before you take

these tablets.

Your doctor will want to monitor your response to this medicine carefully,

particularly if you are young or elderly.

This will probably involve regular examination of your blood every three months

for 18 months and then annually.

Other medicines and Cyanocobalamin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might

take any other medicines.

The absorption of Cyanocobalamin tablets may be affected by:

Neomycin and chloramphenicol which are antibiotics

Colchicine, a treatment for gout

Biguanides, e.g. metformin, which are used to treat diabetes

Cholestyramine which is used to reduce the amount of

cholesterol (fats) in the blood

Potassium chloride which is used to correct potassium deficiency

Methyldopa which is used to treat high blood pressure

Cimetidine which is used to treat excess acid in the stomach causing

indigestion or ulcer

Oral contraceptives.

Antibiotics (used to treat infections) and antimetabolites (used to treat some

cancers) can affect the blood tests to measure vitamin B

Cyanocobalamin Tablets with food, drink and alcohol

Cyanocobalamin Tablets should be swallowed with water and taken between

meals.

Package leaflet: Information for the patient

Cyanocobalamin 50 micrograms Tablets

Vitamin B

12

Open Here

CYANOCOBAL-

aMIN tablets

CYANOCOBAL-

aMIN tablets

BRAILLE READS:

113.0 mm

32.0 mm

77.0 mm

77.0 mm

77.0 mm

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78.0 mm

98.0 mm

561.0 mm

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71.0 mm

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71.0 mm

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72.0 mm

77.0 mm

98.0 mm

78.0 mm

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72.0 mm

71.0 mm

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32.0 mm

26.0 mm

3.0 mm

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32.0 mm

26.0 mm

PAGE 1 OF 1

Dimension:

(LF: 561 x 32mm)

(LB: 113 x 32mm)

Commodity No.:

11001620

Pharma Code:

Core Spec Ref.:

Print Colours:

365 C, 7502 C &

Black

Non-Print Colours:

Cutter & Braille

Min. Font Size:

4 pt

AMS Component No.:

LL-117965-01

Proof Number:

2

Revision Date:

03-May-2019

Product Description:

Cyanocobalamin

50 microgram

Tablets

Component:

Label Leaflet

Product Code:

102040

Country:

Vendor Name:

Recipharm Limited

CRF(s):

PR 30733

Revised by:

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Cytacon 50micrograms Tablets

Cyanocobalamin 50micrograms Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 50 micrograms Cyanocobalamin BP.

Excipient(s) with known effect

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic Indications

Recommended Clinical Indications:

Treatment of nutritional Vitamin B

deficiency.

Treatment of vitamin B 12 deficiency following partial gastrectomy.

Treatment of tropical sprue, alone or with folic acid.

Treatment

pernicious

anaemia

when

parenteral

administration

possible or not advised.

4.2

Posology and method of administration

Posology

Elderly:

The normal dose for adults is appropriate for the elderly.

Adults:

One to three tablets (50 to 150 micrograms) or more daily at the discretion of the

physician.

In pernicious anaemia intramuscular therapy is preferable for initial correction of

vitamin B12 deficiency. However, if necessary, the oral route may be used to follow

this, in which case at least 300 micrograms should be given daily

Paediatric population:

One tablet (50 micrograms) daily at the discretion of the physician.

When possible,

This medicine

doses should be taken between meals.

Method of administration: Oral.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in

section 6.1.

Hypersensitivity to the product or any of the excipients.

4.4

Special Warnings and Special Precautions for use

For pernicious anaemia, an adequate dose must be used and the blood picture

must be examined regularly at least every three months for 18 months until

stabilised, and then annually.

Indiscriminate administration of this medicine may mask precise diagnosis.

Patients with rare hereditary problems of galactose intolerance, total lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

4.5

Interactions

with

other

Medicinal

products

and

other

Forms

of

Interaction

Absorption may be reduced by Para-aminosalicylic acid, colchinine, biguanides,

neomycin, cholestyramine, potassium chloride, methyldopa, and cimetidine.

Patients treated with chloramphenicol may respond poorly to this medicine.

Serum levels of this medicine may be lowered by oral contraceptives. These

interactions are unlikely to have clinical significance.

Anti-metabolities

most

antibiotics

invalidate

vitamins

assays

microbiological techniques.

4.6

Fertility, pregnancy and lactation

Pregnancy

This medicine should not be used to treat megaloblastic anaemia of pregnancy

because this is due to folate deficiency.

4.7

Effects on Ability to Drive and Use Machines

None.

4.8

Undesirable Effects

Sensitisation to this medicine is rare, but may present as an itching exanthema,

and exceptionally as anaphylactic shock.

Acneform and bullous eruptions have been reported rarely.

Patients who have become sensitised to this medicine by injection are often

able to tolerate the oral route without trouble.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal

product is important. It allows continued monitoring of the benefit/risk balance

of the medicinal product. Healthcare professionals are asked to report any

suspected

adverse

reactions

Yellow

Card

Scheme

www.mhra.gov.uk/yellowcard

search

MHRA

Yellow

Card

Google Play or Apple App Store.

4.9

Overdose

Overdosage is unlikely to require treatment.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

his medicine

contain cyanocobalamin vitamin B 12, which is used for the treatment

of pernicious anaemia, and nutritional deficiencies of vitamin B 12 which results in

macrocytic anaemia.

ATC code: B03BA01

5.2

Pharmacokinetic Properties

Absorption

The absorption of cobalamins from the gut is dependent upon the glycoprotein

intrinsic factor.

Distribution

Cobalamins are transported rapidly into the blood bound to protein, known as

transcobalamins.

Elimination

Cobalamins are stored in the liver and excreted in the bile. They are known to

cross the placenta.

5.3

Preclinical safety data

No further relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose BP

Maize Starch BP

Magnesium Stearate BP

Purified Water BP

Film coat

Hydroxypropyl Methylcellulose 2910 Ph.Eur

Ethylcellulose Ph Eur

Acetylated Monoglyceride

Speedcolour

White

27120

Ansteads

(Titanium

dioxide,

talc

polysorbate)

Isopropyl Alcohol BP

Dichloromethane BP

6.2

Incompatibilities

None stated.

6.3

Shelf Life

24 months in securitainers.

24 months in blisters

6.4

Special Precautions for Storage

Securitainer

Protect from light.

Store in well closed containers.

Blisters

Store below 25°C, protected from light.

6.5

Nature and Contents of Container

Polyproylene container with a tamper evident low density polyethylene lid,

containing 50 or 100 Cyanocobalamin Tablets.

Tampertainer staysafe made from high density polyethylene containing 50 or

100 tablets.

PVC/PVdC /Aluminium blister packs with 28, 56 or 112 tablets.

6.6

Instructions for Use, Handling and Disposal

None

7

MARKETING AUTHORISATION HOLDER

Mercury Pharma Group Ltd

Capital House, 85 King William Street,

London EC4N 7BL, UK

8.

MARKETING AUTHORISATION NUMBER

PL 10972/0028

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

06/11/2003

10

DATE OF REVISION OF THE TEXT

24/05/2019

Read the complete document

Public Assessment Report

Cyanocobalamin 50microgram film-coated tablets

(Cyanocobalamin)

UK Licence No: PL 30684/0243

DAWA Limited

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

2

LAY SUMMARY

Cyanocobalamin 50microgram film-coated tablets

(Cyanocobalamin)

This is a summary of the Public Assessment Report (PAR) for Cyanocobalamin 50microgram film-

coated tablets (PL 30684/0243). It explains how Cyanocobalamin 50microgram film-coated tablets were

assessed and their authorisation recommended, as well as the conditions of use. It is not intended to

provide practical advice on how to use Cyanocobalamin 50microgram film-coated tablets.

This product will be referred to as Cyanocobalamin Tablets in this lay summary for ease of reading.

For practical information about using Cyanocobalamin Tablets, patients should read the package leaflet

or contact their doctor or pharmacist.

What are Cyanocobalamin Tablets and what are they used for?

Cyanocobalamin Tablets are a ‘generic medicine’. This means that Cyanocobalamin Tablets are similar

to a ‘reference medicine’ already authorised in the UK called Cytacon 50micrograms

Tablets/Cyanocobalamin 50micrograms Tablets (PL 10972/0028; Mercury Pharma Group Limited).

Cyanocobalamin Tablets are used to treat vitamin B12 deficiency when injections cannot be used.

How do Cyanocobalamin Tablets work?

Cyanocobalamin tablets contain the active ingredient cyanocobalamin, which is known as vitamin B12.

This medicine helps to treat pernicious anaemia (reduction in the number of red blood cells) which is

caused by lack of vitamin B12 in the body.

How are Cyanocobalamin Tablets used?

Cyanocobalamin Tablets are taken by mouth. The tablets must be swallowed with water and should be

taken between meals. Patients should not stop taking this medicine unless advised by a doctor. The

dosage may be adjusted at the discretion of a doctor.

The usual dosage in adults and elderly is one to three tablets daily.

The recommended dose in children is one tablet daily.

This medicine can be obtained from a pharmacy.

For further information on how Cyanocobalamin Tablets are used, please refer to the Summary of

Product Characteristics and the Patient Information Leaflet available on the MHRA website.

How have Cyanocobalamin Tablets been studied?

Because Cyanocobalamin Tablets are a generic medicine, studies in patients have been limited to tests to

determine that they are bioequivalent to the reference medicine, Cytacon 50micrograms

Tablets/Cyanocobalamin 50micrograms Tablets. Two medicines are bioequivalent when they produce

the same levels of the active substance in the body.

What are the benefits and risks of Cyanocobalamin Tablets?

Because Cyanocobalamin Tablets are a generic medicine, and are bioequivalent to the reference

medicine, Cytacon 50micrograms Tablets/Cyanocobalamin 50micrograms Tablets, their benefits and

risks are taken as being the same as the reference medicine.

Why are Cyanocobalamin Tablets approved?

It was concluded that, in accordance with EU requirements, Cyanocobalamin Tablets have been shown

to have comparable quality and to be bioequivalent to Cytacon 50micrograms Tablets/Cyanocobalamin

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

3

50micrograms Tablets. Therefore, the view was that, as for Cytacon 50micrograms

Tablets/Cyanocobalamin 50micrograms Tablets, the benefits outweigh the identified risks.

What measures are being taken to ensure the safe and effective use of Cyanocobalamin Tablets?

A risk management plan has been developed to ensure that Cyanocobalamin Tablets are used as safely

as possible. Based on this plan, safety information has been included in the Summary of Product

Characteristics (SmPC) and the PIL for Cyanocobalamin Tablets, including the appropriate precautions

to be followed by healthcare professionals and patients.

Known side effects are continuously monitored. Furthermore new safety signals reported by patients and

healthcare professionals will also be monitored and reviewed continuously.

Other information about Cyanocobalamin Tablets

A Marketing Authorisation was granted in the UK on 10 April 2017.

The full PAR for Cyanocobalamin Tablets follows this summary.

This summary was last updated in June 2017.

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

4

TABLE OF CONTENTS

Introduction

Page 5

Quality aspects

Page 6

Non-clinical aspects

Page 7

Clinical aspects

Page 8

User consultation

Page 9

Overall conclusion, benefit/risk assessment and

Page 10

recommendation

Table of content of the PAR update

Page 17

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

5

I

INTRODUCTION

Based on the review of the data on quality, safety and efficacy, the Medicines and Healthcare products

Regulatory Agency (MHRA) granted DAWA Limited, a Marketing Authorisation for the medicinal

product Cyanocobalamin 50microgram film-coated tablets (PL 30684/0243) on 10 April 2017. The

product can be obtained from a pharmacy and is used for the following indications:

Treatment of nutritional Vitamin B12 deficiency.

Treatment of vitamin B12 deficiency following partial gastrectomy.

Treatment of tropical sprue, alone or with folic acid.

Treatment of pernicious anaemia when parenteral administration is not possible or not advised.

This application was submitted according to Article 10(1) of Directive 2001/83/EC, as amended,

claiming to be a generic medicinal product of the UK Reference Product, Cytacon 50micrograms

Tablets/Cyanocobalamin 50micrograms Tablets, which was originally granted a Marketing

Authorisation to Mercury Pharma Group Limited (PL 10972/0028) on 16 November 1993.

This medicine contains cyanocobalamin vitamin B12, which is used for the treatment of pernicious

anaemia, and nutritional deficiencies of vitamin B12 which results in macrocytic anaemia.

No new non-clinical or clinical studies were provided with this application.

No bioequivalence study was submitted and this application is based on a Biopharmaceutics

Classification System (BCS) class III biowaiver.

A satisfactory Risk Management Plan (RMP) and a summary of the pharmacovigilance system have

been provided with this application.

No new or unexpected safety concerns arose during the review of information provided by the

Marketing Authorisation Holder and it was, therefore, judged that the benefits of taking

Cyanocobalamin 50microgram film-coated tablets outweigh the risks and a Marketing Authorisation

was granted.

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

6

II

QUALITY ASPECTS

II.1

Introduction

Each film-coated tablet contains 50 microgram cyanocobalamin, as an active ingredient. The excipients

present in this product are cellulose microcrystalline, croscarmellose sodium, povidone, silica, colloidal

anhydrous and magnesium stearate making up the tablet core, and the film coat composed of

hypromellose, propylene glycol and titanium dioxide.

All excipients comply with their respective European Pharmacopoeia monographs. Satisfactory

Certificates of Analysis have been provided for these excipients.

None of the excipients used contain material of animal or human. Confirmation has been given that the

magnesium stearate used in the tablets is of vegetable origin.

The finished product is packaged either in a clear polyvinylchloride (PVC)/polyvinylidenechloride

(PVdC)/aluminium blister packs containing 28, 56, 100 and 112 tablets, or in a securitainer

(polyproylene container with a polyethylene cap) with a silica gel bag in packs containing 50 and 100

tablets.

Satisfactory specifications and Certificates of Analysis have been provided for all packaging

components. All primary packaging complies with the current European regulations concerning

materials in contact with food.

II.2

Drug Substance

INN:

Cyanocobalamin

Chemical name(s):

α-(5,6-Dimethylbenzimidazol-1-yl)cobamide cyanide

Structure:

Molecular formula:

Molecular weight:

1355 g/mol

Appearance:

A dark-red, crystalline powder or dark-red crystals. It is odourless and tasteless.

Solubility:

Sparingly soluble in water and in alcohol, practically insoluble in acetone. The

anhydrous substance is very hygroscopic.

Cyanocobalamin is the subject of a European Pharmacopoeia monograph.

All aspects of the manufacture and control of the active substance, cyanocobalamin, are covered by

European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificates of Suitability.

II.3

Medicinal Product

Pharmaceutical Development

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

7

Suitable pharmaceutical development data have been provided for this application.

The physico-chemical properties of the drug product have been compared with those of the originator

product. These data demonstrate that the proposed product can be considered a generic medicinal

product of Cytacon 50micrograms Tablets/Cyanocobalamin 50micrograms Tablets.

Manufacture of the product

A satisfactory batch formula has been provided for the manufacture of the product, along with an

appropriate account of the manufacturing process. The manufacturing process has been validated and

has shown satisfactory results. Process validation data on commercial batches have been provided. The

results are satisfactory.

Finished Product Specification

The finished product specification is satisfactory. The test methods have been described and have been

adequately validated. Batch data have been provided that comply with the release specification.

Certificates of Analysis have been provided for any working standards used.

Stability of the products

Finished product stability studies have been conducted in accordance with current guidelines and in the

packaging proposed for marketing.

Based on the results, a shelf-life of 24 months for blister and securitainer with storage conditions of “Do

not store above 25ºC” and “Keep the blisters in the outer carton in order to protect from light” for blister

and “Do not store above 25ºC” and “Store in the original package in order to protect from light” for the

securitainer are set. These are satisfactory.

II.4

Discussion on chemical, pharmaceutical and biological aspects

The grant of a Marketing Authorisation is recommended.

III

NON-CLINICAL ASPECTS

III.1

Introduction

The pharmacodynamic, pharmacokinetic and toxicological properties of cyanocobalamin are well-

known. The applicant has submitted a bibliographic review of the pharmacology, pharmacokinetics and

toxicology of cyanocobalamin. The non-clinical overview has been written by an appropriately qualified

person and is a suitable summary of the non-clinical aspects of the dossier. No new non-clinical data

have been supplied with this application. This is acceptable.

III.2

Pharmacology

Not applicable for this product type. Refer to section ‘III.1; Introduction’ detailed above.

III.3

Pharmacokinetics

Not applicable for this product type. Refer to section ‘III.1; Introduction’ detailed above.

III.4

Toxicology

Not applicable for this product type. Refer to section ‘III.1; Introduction’ detailed above.

III.5

Ecotoxicity/environmental risk assessment (ERA)

The Marketing Authorisation holder has provided adequate justification for not submitting an

Environmental Risk Assessment (ERA). This is acceptable as vitamins are unlikely to result in

significant risk to the environment.

III.6

Discussion on the non-clinical aspects

There are no objections to the approval of this product from a non-clinical point of view.

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

8

IV

CLINICAL ASPECTS

IV.1

Introduction

For this generic application, the Applicant applied for a Biopharmaceutics Classification System (BCS)

based biowaiver. No bioequivalence study was performed.

No new clinical data have been submitted and none are required for applications of this type. A clinical

overview has been submitted to justify the biowaiver. The applicant’s clinical overview has been written

by an appropriately qualified person and is considered acceptable.

IV.2

Pharmacokinetics

The Applicant applied for a Biopharmaceutics Classification System (BCS)-based biowaiver. In line

with the ‘Note for Guidance on the investigation of bioavailability and bioequivalence’

(CPMP/EWP/QWP/1401/98 Rev 1/ Corr**), this was considered acceptable as cyanocobalamin is

highly soluble (BCS class III) and the product is an immediate release solid dose preparation for oral use

with the same pharmaceutical form as the reference product. Satisfactory data has been submitted to

justify the BCS biowaiver.

IV.3

Pharmacodynamics

No new pharmacodynamics data were submitted and none were required for an application of this type.

IV.4

Clinical efficacy

No new efficacy data were submitted and none were required for an application of this type.

IV.5

Clinical safety

No new clinical safety data are required for this application and none have been submitted.

IV.6

Risk Management Plan (RMP)

The Marketing Authorisation Holder has submitted a risk management plan, in accordance with the

requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and

interventions designed to identify, characterise, prevent or minimise risks relating to Cyanocobalamin

50microgram film-coated tablets.

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

9

A summary of safety concerns and planned risk minimisation activities, as approved in the RMP,

is listed below:

Routine pharmacovigilance and routine risk minimisation are proposed for all safety concerns.

IV.7

Discussion on the clinical aspects

The grant of a Marketing Authorisation is recommended.

V

USER CONSULTATION

The package leaflet has been evaluated via a user consultation study, in accordance with the

requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC, as amended. The language used for

the purpose of user testing the PIL was English.

The results show that the package leaflet meets the criteria for readability, as set out in the guideline on

the readability of the labelling and package leaflet of medicinal products for human use.

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

10

VI

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

QUALITY

The quality of the product is acceptable and no new non-clinical or clinical concerns have been

identified. Extensive clinical experience with cyanocobalamin is considered to have demonstrated the

therapeutic value of the compound. The benefit risk is, therefore, considered to be positive.

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

11

Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and labelling

In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPCs) and

Patient Information Leaflets (PILs) for products that are granted Marketing Authorisations at a national

level are available on the MHRA website.

The approved labelling for Cyanocobalamin 50microgram film-coated tablets is presented below:

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

12

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

13

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

14

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

15

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

16

PAR Cyanocobalamin 50microgram film-coated tablets

PL 30684/0243

17

Table of content of the PAR update

Steps taken after the initial procedure with an influence on the Public Assessment Report

Date

submitted

Application type

Scope

Outcome

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